Plantar Fasciitis, ChronicITUNCT03254602
Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis
A study testing Intense Therapeutic Ultrasound Treatment in people with Plantar Fasciitis, Chronic, run by University Foot and Ankle Foundation.
Trial summary
A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Plantar Fasciitis, Chronic
- What is being tested?
- Intense Therapeutic Ultrasound Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2016to 10 Apr 2017
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic Pain (>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
- No History of surgery to the affected anatomy.
- No alternative treatment procedures within the last 90 days.
- Age: 18 - 85, depending on the study.
- Unilateral Pain
- Willingness to complete treatment and post treatment regimen as described.
- Patients who have provided written and verbal informed consent.
Who cannot join
- Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
- Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
- Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
- At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
About this study
Official title: Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction
A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.
Read the detailed description
Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.
- Conditions
- Plantar Fasciitis, Chronic
- Being tested
- Intense Therapeutic Ultrasound Treatment
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Therapeutic Ultrasound TreatmentDevice
Also called Guided Therapy Systems, Ardent Sound, GTS, ITU, Actisound
| Study group | Role | What they receive |
|---|---|---|
| Intense Therapeutic Ultrasound Treatment | Experimental | Intense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart. Receives: Device: Intense Therapeutic Ultrasound Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction
Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.
Measured: At 12 weeks after the first treatment
Secondary outcomes (2)
Ultrasound Changes
Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments
Measured: At 12 Weeks after the first treatment
Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline
Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)
Measured: At 12 Weeks after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start4 Aug 2016
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
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 (6)Papers the sponsor has linked to this study.
- Other trials for Plantar Fasciitis, ChronicStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Foot and Ankle Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Guided Therapy Systems
- Responsible party
- Sponsor
- Investigators
- Bob Baravarian, DPM, Principal investigator, University Foot and Ankle Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254602
- Sponsor's protocol ID
- 20160753
- Acronym
- ITU
- Status last verified
- Oct 2017
- First submitted
- 14 Aug 2017
- Last updated
- 7 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.
PubMed 17224484Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.
PubMed 20115948Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.
PubMed 17372061Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.
PubMed 18429926Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
PubMed 12696985Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305.
PubMed 16801514
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Therapeutic Ultrasound for the Treatment of Chronic Plantar Fasciitis Musculoskeletal Pain Reduction
- ClinicalTrials.gov ID
- NCT03254602
- Acronym / sponsor ID
- ITU / 20160753
- Conditions
- Plantar Fasciitis, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Foot and Ankle FoundationUniversity, hospital or other
- Collaborators
- Guided Therapy Systems
- Study start
- 4 Aug 2016 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Posted 17 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical trial evaluating the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, Plantar Fasciitis musculoskeletal tissue pain reduction began in August 2016 and was completed in April 2017. The clinical setting: University Foot and Ankle Institute, Santa Monica, California, USA; Single-Blinded, pivotal study for chronic plantar fasciitis.
Detailed description
Intense Therapeutic Ultrasound (ITU) is an established ultrasound based therapy in which sound waves are concentrated and focused into selected musculoskeletal tissue, to produce selective thermal coagulative changes over a small controlled area while leaving the surrounding tissue unaffected. These coagulative changes are known to begin the body's tissue response cascade and promote collagen generation in the targeted anatomy resulting in pain reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Intense Therapeutic Ultrasound Treatment | Experimental | Device: Intense Therapeutic Ultrasound TreatmentIntense Therapeutic Ultrasound treatment applied along the length and width of the proximal Plantar Fascia. 1000 - 5 Joule pulses were applied twice, four weeks apart. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic Pain (>90 days) from previously diagnosed Plantar Fasciitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
- No History of surgery to the affected anatomy.
- No alternative treatment procedures within the last 90 days.
- Age: 18 - 85, depending on the study.
- Unilateral Pain
Key exclusion criteria (4 listed)
- Patients currently enrolled in any other non-conservative, device, or Investigational New Drug clinical trial, or who have participated in a clinical study involving the Plantar Fascia, thirty days prior to study initiation;
- Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
- Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
- At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.
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 |
|---|---|---|
| Intense Therapeutic Ultrasound TreatmentAlso: Guided Therapy Systems, Ardent Sound, GTS, ITU, Actisound | Device | Intense Therapeutic Ultrasound Treatment |
Primary outcome
Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction
Time frame: At 12 weeks after the first treatment
Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.
2 secondary outcomes
Ultrasound Changes
Time frame: At 12 Weeks after the first treatment
Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline
Time frame: At 12 Weeks after the first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17224484White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.
- Background: PubMed 20115948Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.
- Background: PubMed 17372061Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.
- Background: PubMed 18429926Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.
- Background: PubMed 12696985Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.
- Background: PubMed 16801514Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006 Jun 26;166(12):1305-10. doi: 10.1001/archinte.166.12.1305.
- 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.
Bob Baravarian, DPM principal investigator
University Foot and Ankle Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Intense Therapeutic Ultrasound Treatment in people with Plantar Fasciitis, Chronic, run by University Foot and Ankle Foundation.
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 7 inclusion and 4 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 17 Nov 2017). 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?
Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction (time frame: At 12 weeks after the first treatment). 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 NCT03254602, which also lists 6 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 7 Dec 2017.