Achilles TendinopathyNCT04725513
Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
A study testing Shockwave Therapy, Photobiomodulation Therapy and Physical Therapy in people with Achilles Tendinopathy, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Shockwave Therapy, Photobiomodulation Therapy and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 1 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
- Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running
- VISA-A <80 at baseline to be eligible
Who cannot join
- Less than 3 months of symptoms
- Primary insertional Achilles tendinopathy
- Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT
- Have received SWT within the past 3 months to their Achilles
- Prior injection within 3 months
- Currently enrolled in PT for more than 4 weeks for their condition
Show all 9Show fewer
- Women who are pregnant.
- known history of Achilles tendon tear
- currently taking oral steroid or fluoroquinolone class of antibiotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
About this study
Official title: Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, a Combination of Shockwave Therapy and Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy: A Randomized Control Trial With Elective Cross-Over Design
This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.
Read the detailed description
This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.
- Conditions
- Achilles Tendinopathy
- Being tested
- Shockwave Therapy, Photobiomodulation Therapy, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave TherapyDevice
Participants will receive shockwave therapy once a week for three weeks
Photobiomodulation TherapyDevice
Participants will receive photobiomodulation therapy twice a week for three weeks
Physical TherapyOther
Participants will enroll in physical therapy and complete an at-home exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Only | Active comparator | Not described Receives: Other: Physical Therapy |
| Shockwave Therapy and Physical Therapy | Experimental | Not described Receives: Device: Shockwave Therapy; Other: Physical Therapy |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | Experimental | Not described Receives: Device: Shockwave Therapy; Device: Photobiomodulation Therapy; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calf Raises Performed to Fatigue and Inability to Continue
Calf raises performed to fatigue and inability to continue
Measured: Difference from 0-3 months
Ultrasound Measurements in Change of Cross Sectional Area
Changes in the cross-sectional area measured on ultrasound
Measured: Difference from 0-3 months
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better).
Measured: change from baseline to 3 month follow-up measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start29 Aug 2022
- Primary completion1 Sep 2024
- Study completion1 Oct 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- The first part of the study is a randomized control trial, the second part is an elective cross over
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Tenforde, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725513
- Sponsor's protocol ID
- 2021P000025
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2021
- Last updated
- 12 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tenforde AS, Pham L, Gaudette LW, Funk MM, Vogel KE, Bruneau MM, Yuan X, Schroeder JD, Isaacson B, Hagar N, Metzger E, Nolan DC, Tam J, Silbernagel KG. Exercise, radial pressure waves, and photobiomodulation for management of non-insertional Achilles tendinopathy in runners: a three-arm non-blinded randomised control trial. BMJ Open Sport Exerc Med. 2025 Oct 5;11(4):e002442. doi: 10.1136/bmjsem-2024-002442. eCollection 2025.
PubMed 41070206Tenforde AS, Vogel KEL, Tam J, Silbernagel KG. Research protocol to evaluate the effectiveness of shockwave therapy, photobiomodulation and physical therapy in the management of non-insertional Achilles tendinopathy in runners: a randomised control trial with elective cross-over design. BMJ Open Sport Exerc Med. 2022 Sep 27;8(3):e001397. doi: 10.1136/bmjsem-2022-001397. eCollection 2022.
PubMed 36187084
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, a Combination of Shockwave Therapy and Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy: A Randomized Control Trial With Elective Cross-Over Design
- ClinicalTrials.gov ID
- NCT04725513
- Acronym / sponsor ID
- 2021P000025
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Posted 12 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.
Detailed description
This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The first part of the study is a randomized control trial, the second part is an elective cross over
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Only | Active comparator | Other: Physical Therapy |
| Shockwave Therapy and Physical Therapy | Experimental | Device: Shockwave Therapy, Other: Physical Therapy |
| Photobiomodulation, Shockwave Therapy and Physical Therapy | Experimental | Device: Shockwave Therapy, Device: Photobiomodulation Therapy, Other: Physical Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
- Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running
- VISA-A <80 at baseline to be eligible
Key exclusion criteria (9 listed)
- Less than 3 months of symptoms
- Primary insertional Achilles tendinopathy
- Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT
- Have received SWT within the past 3 months to their Achilles
- Prior injection within 3 months
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 |
|---|---|---|
| Shockwave TherapyParticipants will receive shockwave therapy once a week for three weeks | Device | Photobiomodulation, Shockwave Therapy and Physical Therapy, Shockwave Therapy and Physical Therapy |
| Photobiomodulation TherapyParticipants will receive photobiomodulation therapy twice a week for three weeks | Device | Photobiomodulation, Shockwave Therapy and Physical Therapy |
| Physical TherapyParticipants will enroll in physical therapy and complete an at-home exercise protocol | Other | Photobiomodulation, Shockwave Therapy and Physical Therapy, Physical Therapy Only, Shockwave Therapy and Physical Therapy |
Primary outcome
Calf Raises Performed to Fatigue and Inability to Continue
Time frame: Difference from 0-3 months
Calf raises performed to fatigue and inability to continue
Ultrasound Measurements in Change of Cross Sectional Area
Time frame: Difference from 0-3 months
Changes in the cross-sectional area measured on ultrasound
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
Time frame: change from baseline to 3 month follow-up measure
Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41070206Tenforde AS, Pham L, Gaudette LW, Funk MM, Vogel KE, Bruneau MM, Yuan X, Schroeder JD, Isaacson B, Hagar N, Metzger E, Nolan DC, Tam J, Silbernagel KG. Exercise, radial pressure waves, and photobiomodulation for management of non-insertional Achilles tendinopathy in runners: a three-arm non-blinded randomised control trial. BMJ Open Sport Exerc Med. 2025 Oct 5;11(4):e002442. doi: 10.1136/bmjsem-2024-002442. eCollection 2025.
- Derived from this study: PubMed 36187084Tenforde AS, Vogel KEL, Tam J, Silbernagel KG. Research protocol to evaluate the effectiveness of shockwave therapy, photobiomodulation and physical therapy in the management of non-insertional Achilles tendinopathy in runners: a randomised control trial with elective cross-over design. BMJ Open Sport Exerc Med. 2022 Sep 27;8(3):e001397. doi: 10.1136/bmjsem-2022-001397. eCollection 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Therapy, Photobiomodulation Therapy and Physical Therapy in people with Achilles Tendinopathy, run by Spaulding Rehabilitation Hospital 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 3 inclusion and 9 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 12 Jan 2026. 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 12 Jan 2026). 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?
Calf Raises Performed to Fatigue and Inability to Continue (time frame: Difference from 0-3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725513, which also lists 2 linked publications.
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 12 Jan 2026.