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Compensation: Varies

Number of Visits: 14

Duration: 3 weeks

48 Participants Needed

Combination Therapies for Achilles Tendinopathy

Overseen ByRobert Rossi

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Must not be taking: Heat/light sensitivity drugs

Disqualifiers: Cardiac disease, Neuropathy, Sciatica, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that make you sensitive to heat or light, like doxycycline or naproxen.

What data supports the effectiveness of this treatment for Achilles tendinopathy?

Research suggests that physical therapy, including progressive tendon-loading exercises, is effective for improving Achilles tendinopathy. Additionally, shockwave therapy may be beneficial for cases that do not respond to initial treatments.¹ ² ³ ⁴ ⁵

How is physical therapy unique for treating Achilles tendinopathy?

Physical therapy for Achilles tendinopathy is unique because it focuses on progressive tendon-loading exercises, which help strengthen the tendon and improve its function. This approach is different from other treatments like injections or shockwave therapy, which are more invasive and often used when physical therapy alone is not effective.¹ ³ ⁶ ⁷ ⁸

What is the purpose of this trial?

This trial is comparing different treatments for people with a painful Achilles tendon condition. It looks at regular physical therapy, physical therapy with a special light treatment, physical therapy with a high-energy sound wave treatment, and physical therapy with both light and sound wave treatments. The goal is to find out which combination works best to reduce pain and improve movement.

Research Team

Jeremy D Schroeder

Principal Investigator

Madigan Army Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Able to read and understand English language for consent purposes

DEERS Eligible

Currently Active Duty in any of the US Armed Forces

See 2 more

Exclusion Criteria

I finished the Silbernagel protocol for Achilles tendinopathy recently.

I have had shock wave therapy on my Achilles in the last 3 months.

I have a heart condition that could be worsened by shock wave therapy.

See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive physical therapy (PT) with various combinations of shockwave therapy (SWT) and photobiomodulation therapy (PBMT) for three weeks

3 weeks

8 visits (in-person), additional check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

6-week follow-up (virtual or in-person), 3-month follow-up (in-person)

Treatment Details

Interventions

Photobiomodulation Therapy
Physical Therapy
Shockwave Therapy

Trial Overview 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.

Participant Groups

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.