Achilles TendinopathyNCT05751785
Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
A study testing Physical Therapy, Shockwave Therapy and Photobiomodulation Therapy in people with Achilles Tendinopathy, run by Musculoskeletal Injury Rehabilitation Research for Operational Readiness at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Physical Therapy, Shockwave Therapy and Photobiomodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 14 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DEERS Eligible
- Between the ages of 18-64
- Currently Active Duty in any of the US Armed Forces
- Clinical diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral) by a healthcare provider based on accepted diagnostic criteria.
- Able to read and understand English language for consent purposes
- Able to commit to 3-weeks of intervention and 6-months of follow-up
Who cannot join
- Primary insertional Achilles tendinopathy
- Platelet Rich Plasma (PRP), corticosteroid injection, or prolotherapy within 3 months
- Received dry needling within the past 4 weeks
- Previously completed the Silbernagel protocol for Achilles tendinopathy within the past 3 months
- Received SWT within the past 3 months to their Achilles
- Tattoo in the area of treatment (due to sensitivity to PBMT)
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- Current use of pacemaker
- Patients with a known underlying cardiac disease that could be affected by SWT
- Patients with neuropathy affecting sensation to pain
- Current use of medications associated with sensitivity to heat or light (e.g. amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)
- Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling.
- Achilles tendon tear or prior Achilles tendon surgery
- Recent lower extremity injury within the last 3 months that required professional medical attention (e.g., ankle sprain, meniscus)
- Concurrent participation in another research study addressing pain issue
- Previously enrolled in the study for contralateral (opposite) leg
- Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy) as determined by hCG urine test
- Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside of Achilles tendinopathy, or other contraindications to PBMT or SWT
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Investigation of the Effectiveness of Shockwave Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function, decrease pain, and resolve symptoms in individuals with non-insertional Achilles tendinopathy. The main question it aims to answer is:
- What is the most effective treatment method for non-insertional Achilles tendinopathy?
Participants will
Researchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.
Read the detailed description
Non-insertional Achilles Tendinopathy (AT) is a common overuse injury in adults who are both athletes and nonactive. Tendinopathy occurs when there is either a failed healing response or the failure of normal turnover or remodeling response, and results in pain and limited movement. In the military, lower-extremity injuries due to overuse, (e.g., AT) are the most common category of injuries. The most common treatment of choice for AT is exercise loading programs, however eccentric strengthening (ECC) may only improve symptoms in approximately 60% of patients. Laser-induced photobiomodulation (PBM) has been shown to increase cell proliferation and metabolism, which may aid in the repair and remodeling process. Studies have found that PBM was effective in the treatment of AT. Extracorporeal shockwave therapy (ESWT) is a process in which energy is delivered to the muscles or tendons for pain relief. Current literature supports the use of ESWT as an effective treatment for AT in combination with ECC. Overall, studies indicate that ESWT and photobiomodulation therapy (PBMT) will be effective in treating tendon injuries such as AT, however, these treatment methods have not been evaluated in comparison or combination with each other. The sub-section of AT amongst Active-Duty personnel has very limited research and given the high prevalence, should be addressed. Therefore, our study will compare three different treatment arms utilizing traditional physical therapy (PT), PT plus ESWT, PT plus PBMT, and PT plus ESWT and PBMT. Both self-reported questionnaires and measured outcomes will be used to assess the most effective treatment for AT.
- Conditions
- Achilles Tendinopathy
- Being tested
- Physical Therapy, Shockwave Therapy, Photobiomodulation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Also called SOC PT
All participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving.
Shockwave TherapyDevice
Also called SWT
A medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment.
Photobiomodulation TherapyDevice
Also called PBMT
PBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm^2 that is applied in a serpentine manner over the site of injury.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy (PT) Only | Active comparator | Participants in the PT only arm will follow the PT program outlined above. Twice a week for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check-in Data Collection CRF). These check-ins may occur virtually or in person.
In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). Receives: Other: Physical Therapy |
| PT + Photobiomodulation Therapy (PBMT) | Active comparator | The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above.
A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W. Receives: Other: Physical Therapy; Device: Photobiomodulation Therapy |
| PT + Shockwave Therapy (SWT) | Active comparator | The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment described above. Twice a week, for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check- in Data Collection CRF). The first check-in of the week will occur in-person after the SWT, if, however, this is not feasible, it may be conducted virtually; the second check-in of the week may occur virtually or in-person.
In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes. Receives: Other: Physical Therapy; Device: Shockwave Therapy |
| PT + SWT and PBMT | Active comparator | The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described above. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF).
In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person). Receives: Other: Physical Therapy; Device: Shockwave Therapy; Device: Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Measured: Baseline
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Measured: 3-week
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations.
Measured: 6-week
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Measured: 12-week
Victorian Institute of Sports Assessment - Achilles (VISA-A)
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Measured: 6-month
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80.
Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Measured: Baseline
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80.
Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Measured: 3-week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80.
Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Measured: 6-week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80.
Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Measured: 12-week
Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80.
Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Measured: 6-month
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: Baseline
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: 3-week
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: 6-week
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: 12-week
Defense and Veteran's Pain Rating Scale (DVPRS)
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: 6-month
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Measured: Baseline
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Measured: 3-week
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Measured: 6-week
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Measured: 12-week
University of Wisconsin Running Injury and Recovery Index (UWRI)
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Measured: 6-month
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Measured: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Measured: 3-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Measured: 6-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Measured: 12-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Measured: 6-month
Cross-sectional Area
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Measured: Baseline
Cross-sectional Area
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Measured: 12-week
Cross Sectional Area
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Measured: 6-month
Width
Measures of interest include width of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Measured: Baseline
Width
Measures of interest include width of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Measured: 12-week
Width
Measures of interest include width of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Measured: 6-month
Degree of Thickening
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Measured: Baseline
Degree of Thickening
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Measured: 12-week
Degree of Thickening
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Measured: 6-month
Relative Neovascularity
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at baseline for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Measured: Baseline
Relative Neovascularity
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at 12 weeks for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Measured: 12-week
Relative Neovascularity
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at 6 months for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel's in up to 30% of the ROI
Measured: 6-months
Elastography
Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs.
Measured: Baseline
Elastography
Measures of interest include elastography. A study team member will assess ultrasound measures at 12 weeks for both limbs.
Measured: 12-week
Elastography
Measures of interest include elastography. A study team member will assess ultrasound measures at 6 months for both limbs.
Measured: 6 Months
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Quantitative function in heel raises to fatigue on both limbs.
Measured: Baseline
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Quantitative function in heel raises to fatigue on both limbs.
Measured: 12-week
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Quantitative function in heel raises to fatigue on both limbs.
Measured: 6 Months
Hops
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: Baseline
Hops
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: 12-week
Hops
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Measured: 6 Months
Ankle Range of Motion (ROM)
Quantitative function in range of motion (ROM).
Measured: Baseline
Ankle Range of Motion (ROM)
Quantitative function in range of motion (ROM)
Measured: 12-week
Ankle Range of Motion (ROM)
Quantitative function in range of motion (ROM)
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start13 Feb 2023
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational Readiness
- Sponsor type
- US federal agency
- Collaborators
- Fort Belvoir Community Hospital, The Geneva Foundation
- Responsible party
- Sponsor
- Investigators
- Jeremy D Schroeder, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751785
- Sponsor's protocol ID
- Photomedicine Project 10
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2023
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Shockwave Therapy, Photobiomodulation, and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT05751785
- Acronym / sponsor ID
- Photomedicine Project 10
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational ReadinessUS federal agency
- Collaborators
- Fort Belvoir Community Hospital, The Geneva Foundation
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 2 Mar 2023 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function, decrease pain, and resolve symptoms in individuals with non-insertional Achilles tendinopathy. The main question it aims to answer is:
- What is the most effective treatment method for non-insertional Achilles tendinopathy?
Participants will
Researchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.
Detailed description
Non-insertional Achilles Tendinopathy (AT) is a common overuse injury in adults who are both athletes and nonactive. Tendinopathy occurs when there is either a failed healing response or the failure of normal turnover or remodeling response, and results in pain and limited movement. In the military, lower-extremity injuries due to overuse, (e.g., AT) are the most common category of injuries. The most common treatment of choice for AT is exercise loading programs, however eccentric strengthening (ECC) may only improve symptoms in approximately 60% of patients. Laser-induced photobiomodulation (PBM) has been shown to increase cell proliferation and metabolism, which may aid in the repair and remodeling process. Studies have found that PBM was effective in the treatment of AT. Extracorporeal shockwave therapy (ESWT) is a process in which energy is delivered to the muscles or tendons for pain relief. Current literature supports the use of ESWT as an effective treatment for AT in combination with ECC. Overall, studies indicate that ESWT and photobiomodulation therapy (PBMT) will be effective in treating tendon injuries such as AT, however, these treatment methods have not been evaluated in comparison or combination with each other. The sub-section of AT amongst Active-Duty personnel has very limited research and given the high prevalence, should be addressed. Therefore, our study will compare three different treatment arms utilizing traditional physical therapy (PT), PT plus ESWT, PT plus PBMT, and PT plus ESWT and PBMT. Both self-reported questionnaires and measured outcomes will be used to assess the most effective treatment for AT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy (PT) Only | Active comparator | Other: Physical TherapyParticipants in the PT only arm will follow the PT program outlined above. Twice a week for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check-in Data Collection CRF). These check-ins may occur virtually or in person. In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person). |
| PT + Photobiomodulation Therapy (PBMT) | Active comparator | Other: Physical Therapy, Device: Photobiomodulation TherapyThe physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above. A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W. |
| PT + Shockwave Therapy (SWT) | Active comparator | Other: Physical Therapy, Device: Shockwave TherapyThe physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment described above. Twice a week, for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check- in Data Collection CRF). The first check-in of the week will occur in-person after the SWT, if, however, this is not feasible, it may be conducted virtually; the second check-in of the week may occur virtually or in-person. In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes. |
| PT + SWT and PBMT | Active comparator | Other: Physical Therapy, Device: Shockwave Therapy, Device: Photobiomodulation TherapyThe PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described above. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF). In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- DEERS Eligible
- Between the ages of 18-64
- Currently Active Duty in any of the US Armed Forces
- Clinical diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral) by a healthcare provider based on accepted diagnostic criteria.
- Able to read and understand English language for consent purposes
Key exclusion criteria (17 listed)
- Primary insertional Achilles tendinopathy
- Platelet Rich Plasma (PRP), corticosteroid injection, or prolotherapy within 3 months
- Received dry needling within the past 4 weeks
- Previously completed the Silbernagel protocol for Achilles tendinopathy within the past 3 months
- Received SWT within the past 3 months to their Achilles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyAlso: SOC PTAll participants may complete a PT program as standard of care (SOC) treatment addressing individual strength, mobility, and flexibility deficits in both proximal (e.g. spine and hip girdle) along with distal (thigh, leg, and foot/ankle) muscle groups. The provider may also use other modalities to address distal issues. To standardize the loading program, all participants will be given an at-home exercise program designed by Dr. Karin Sibernagel for progressive Achilles tendon loading. The participants will also follow the University of Delaware Return to Sport protocol for return to running. This will be completed alongside the standard of care PT participants will be receiving. | Other | PT + Photobiomodulation Therapy (PBMT), PT + SWT and PBMT, PT + Shockwave Therapy (SWT), Physical Therapy (PT) Only |
| Shockwave TherapyAlso: SWTA medical provider will conduct SWT on study participants using the OrthoPlus Ultra 100. This Extracorporeal Pressure Activation Treatment device will be used at a radial shockwave of 3000 counts treatment settings of 15 Hz minimum 2 bars with a focus applicator head at mid-portion of Achilles using clinical focusing technique, and 3000 counts at 15 Hz minimum 2.5 bars using broad oscillator to myotendinous region and over symptomatic areas of gastrocnemius and soleus, treatment will be applied distally to proximally to facilitate lymphatic return adjusting treatment air pressure and amount of force applied by applicator head by patient comfort. The maximum setting for each treatment applicator will be 4 bars of air pressure, and the first 500 counts using each applicator will be applied at 1.5 bars to help desensitize the tissue prior to increasing energy settings. The settings used for each participant will be recorded and followed in a similar approach to treatment. | Device | PT + SWT and PBMT, PT + Shockwave Therapy (SWT) |
| Photobiomodulation TherapyAlso: PBMTPBMT is delivered with the LightForce® XPi 25W device through the Smart Hand Piece technology. The therapy is transmitted with a rolling glass massage ball at 10 Joules/cm^2 that is applied in a serpentine manner over the site of injury. | Device | PT + Photobiomodulation Therapy (PBMT), PT + SWT and PBMT |
Primary outcome
Victorian Institute of Sports Assessment - Achilles (VISA-A)
Time frame: Baseline
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Victorian Institute of Sports Assessment - Achilles (VISA-A)
Time frame: 3-week
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Victorian Institute of Sports Assessment - Achilles (VISA-A)
Time frame: 6-week
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations.
Victorian Institute of Sports Assessment - Achilles (VISA-A)
Time frame: 12-week
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Victorian Institute of Sports Assessment - Achilles (VISA-A)
Time frame: 6-month
The VISA-A (Victorian Institute of Sport Assessment - Achilles) is a questionnaire designed to assess the severity of Achilles tendinopathy. It consists of eight questions that evaluate pain, function in daily life, and sports activities. The minimum score is 0 and the maximum score is 100, with lower scores indicating more severe symptoms and limitations
Lower Extremity Functional Scale (LEFS)
Time frame: Baseline
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Lower Extremity Functional Scale (LEFS)
Time frame: 3-week
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Lower Extremity Functional Scale (LEFS)
Time frame: 6-week
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Lower Extremity Functional Scale (LEFS)
Time frame: 12-week
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Lower Extremity Functional Scale (LEFS)
Time frame: 6-month
The Lower Extremity Functional Scale (LEFS) is a questionnaire used to assess a person's ability to perform everyday activities involving the lower limbs. It consists of 20 questions, each scored from 0 to 4, with a minimum score of 0 and maximum total score of 80. Key Points: Higher scores indicate better lower extremity function. Lower scores suggest greater disability or difficulty in movement.
Defense and Veteran's Pain Rating Scale (DVPRS)
Time frame: Baseline
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Defense and Veteran's Pain Rating Scale (DVPRS)
Time frame: 3-week
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Defense and Veteran's Pain Rating Scale (DVPRS)
Time frame: 6-week
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Defense and Veteran's Pain Rating Scale (DVPRS)
Time frame: 12-week
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Defense and Veteran's Pain Rating Scale (DVPRS)
Time frame: 6-month
The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: Baseline
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: 3-week
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: 6-week
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: 12-week
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
University of Wisconsin Running Injury and Recovery Index (UWRI)
Time frame: 6-month
The University of Wisconsin Running Injury and Recovery Index (UWRI) is a questionnaire designed to assess a runner's recovery from running-related injuries. Scores range from 0-36, with higher scores equaling better outcomes.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 3-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 6-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 12-week
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 6-month
Patient-Reported Outcomes Measurement Information System (PROMIS-29) has seven categories: Physical Function (higher scores = better function), Anxiety (higher scores = more anxiety), Depression (higher scores = more depression), Fatigue (higher scores = more fatigue), Sleep Disturbance (higher scores = more disturbance during sleep), Pain (higher scores = more pain), and Social Function (higher scores = more socialization). Minimum score is 20 and maximum is 80 for each of the seven categories.
Cross-sectional Area
Time frame: Baseline
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Cross-sectional Area
Time frame: 12-week
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Cross Sectional Area
Time frame: 6-month
Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Width
Time frame: Baseline
Measures of interest include width of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Width
Time frame: 12-week
Measures of interest include width of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Width
Time frame: 6-month
Measures of interest include width of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Degree of Thickening
Time frame: Baseline
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Degree of Thickening
Time frame: 12-week
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 12 weeks for both limbs, measured in centimeters (cm).
Degree of Thickening
Time frame: 6-month
Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at 6 months for both limbs, measured in centimeters (cm).
Relative Neovascularity
Time frame: Baseline
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at baseline for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Relative Neovascularity
Time frame: 12-week
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at 12 weeks for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 1: 1 to 2 vessels within the region of interest, grade 2: 3 to 5 vessels within the region of interest (ROI), or grade 3: vessel's in up to 30% of the ROI.
Relative Neovascularity
Time frame: 6-months
Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at 6 months for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel's in up to 30% of the ROI
Elastography
Time frame: Baseline
Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs.
Elastography
Time frame: 12-week
Measures of interest include elastography. A study team member will assess ultrasound measures at 12 weeks for both limbs.
Elastography
Time frame: 6 Months
Measures of interest include elastography. A study team member will assess ultrasound measures at 6 months for both limbs.
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Time frame: Baseline
Quantitative function in heel raises to fatigue on both limbs.
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Time frame: 12-week
Quantitative function in heel raises to fatigue on both limbs.
Heel Raises-Quantitative Function in Heel Raises to Fatigue.
Time frame: 6 Months
Quantitative function in heel raises to fatigue on both limbs.
Hops
Time frame: Baseline
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Hops
Time frame: 12-week
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Hops
Time frame: 6 Months
Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS). The Defense and Veterans Pain Rating Scale (DVPRS) is a pain assessment tool designed specifically for military personnel and veterans Rating scale from 0-10. Higher scores equal worse outcomes.
Ankle Range of Motion (ROM)
Time frame: Baseline
Quantitative function in range of motion (ROM).
Ankle Range of Motion (ROM)
Time frame: 12-week
Quantitative function in range of motion (ROM)
Ankle Range of Motion (ROM)
Time frame: 6 Months
Quantitative function in range of motion (ROM)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy D Schroeder principal investigator
Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy, Shockwave Therapy and Photobiomodulation Therapy in people with Achilles Tendinopathy, run by Musculoskeletal Injury Rehabilitation Research for Operational Readiness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute of Sports Assessment - Achilles (VISA-A) (time frame: Baseline). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.