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Combination Therapies for Achilles Tendinopathy

N/A
Waitlist Available
Led By Jeremy D Schroeder
Research Sponsored by Musculoskeletal Injury Rehabilitation Research for Operational Readiness
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month
Awards & highlights

Study Summary

This trial aims to determine the best way to reduce pain and improve function in people with Achilles tendinopathy: standard of care PT, PT + PBMT, PT + SWT, or PT + SWT & PBMT.

Who is the study for?
Active duty US Armed Forces members aged 18-64 with a clinical diagnosis of mid-portion Achilles tendinopathy can join. They must be able to read English, commit to a 3-week treatment and 6-month follow-up. Exclusions include recent treatments like dry needling or shockwave therapy, tattoos in the treatment area, pacemaker use, certain heart diseases or medications, current sciatica symptoms, tendon injuries/surgery, other pain studies participation, pregnancy plans during the study period.Check my eligibility
What is being tested?
The trial is testing how well different combinations of physical therapy (PT) work for Achilles tendinopathy. It compares standard PT alone versus PT with low-level laser therapy (photobiomodulation), high-energy acoustic wave therapy (shockwave), and both therapies combined. The aim is to find out which method best improves function and reduces pain.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of treatment from shockwave or photobiomodulation therapies such as redness or swelling. There's also a risk of bruising from physical manipulation during PT sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ankle range of motion
Cross Sectional area
Cross-sectional area
+11 more

Trial Design

4Treatment groups
Active Control
Group I: PT + Shockwave Therapy (SWT)Active Control2 Interventions
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.
Group II: PT + SWT and PBMTActive Control3 Interventions
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).
Group III: Physical Therapy (PT) OnlyActive Control1 Intervention
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).
Group IV: PT + Photobiomodulation Therapy (PBMT)Active Control2 Interventions
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Physical Therapy (PT) for Achilles Tendinopathy typically involves exercise and manual techniques aimed at improving tendon strength, flexibility, and function. This helps in reducing pain and preventing further injury. Photobiomodulation Therapy (PBMT), or Low-Level Laser Therapy, uses specific wavelengths of light to reduce inflammation and promote tissue healing at the cellular level. Shockwave Therapy (SWT) employs high-energy acoustic waves to stimulate blood flow and cellular repair processes, which can accelerate tendon healing and reduce pain. These treatments are important for Achilles Tendinopathy patients as they target the underlying issues of tendon damage and inflammation, promoting recovery and improving overall tendon health.
Education and exercise supplemented by a pain-guided hopping intervention for male recreational runners with midportion Achilles tendinopathy: A single cohort feasibility study.

Find a Location

Who is running the clinical trial?

Musculoskeletal Injury Rehabilitation Research for Operational ReadinessLead Sponsor
3 Previous Clinical Trials
350 Total Patients Enrolled
The Geneva FoundationOTHER
33 Previous Clinical Trials
12,700 Total Patients Enrolled
1 Trials studying Achilles Tendinopathy
16 Patients Enrolled for Achilles Tendinopathy
Fort Belvoir Community HospitalFED
13 Previous Clinical Trials
2,096 Total Patients Enrolled

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05751785 — N/A
Achilles Tendinopathy Research Study Groups: PT + Shockwave Therapy (SWT), PT + SWT and PBMT, Physical Therapy (PT) Only, PT + Photobiomodulation Therapy (PBMT)
Achilles Tendinopathy Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT05751785 — N/A
Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05751785 — N/A
~8 spots leftby Sep 2024
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