Combination Therapies for Achilles Tendinopathy

Overseen By Robert 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 Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best treatment for non-insertional Achilles tendinopathy, which causes pain in the middle part of the Achilles tendon. It compares the effectiveness of various combinations of physical therapy, photobiomodulation therapy (a type of light therapy), and shockwave therapy (a treatment using sound waves). Individuals diagnosed with mid-portion Achilles tendinopathy, who are active duty in the U.S. Armed Forces, and can commit to a 3-week treatment and 6-month follow-up, qualify as good candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment options for Achilles tendinopathy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that physical therapy (PT) is a safe and effective treatment for tendon issues, such as Achilles tendinopathy. Exercise therapy, a key component of PT, has significantly reduced pain and improved movement over time.

Studies indicate that shockwave therapy (SWT) is a safe and effective method to reduce pain and enhance function in Achilles tendinopathy, with many individuals reporting positive results.

Photobiomodulation therapy (PBMT) uses low-level lasers to aid tissue healing. However, evidence supporting its regular use for Achilles tendinopathy remains weak. Some studies suggest it can help with pain and movement, but the quality of this evidence is low.

Overall, PT and SWT are well-tolerated and have strong evidence supporting their safety. While PBMT shows some potential, the evidence is less certain. Participants should consider these findings when deciding whether to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these combination therapies for Achilles tendinopathy because they offer innovative approaches that go beyond standard treatments like rest, ice, and anti-inflammatory medications. The addition of Shockwave Therapy (SWT) and Photobiomodulation Therapy (PBMT) to physical therapy (PT) brings new mechanisms of action. SWT uses sound waves to stimulate healing, while PBMT uses light to reduce pain and inflammation at a cellular level. This multi-faceted approach might enhance recovery and lead to more effective results, potentially transforming how Achilles tendinopathy is managed.

What evidence suggests that this trial's treatments could be effective for Achilles tendinopathy?

Research has shown that shockwave therapy (SWT), a treatment in this trial, can help with Achilles tendinopathy by reducing pain and improving mobility. One study found that SWT eased pain and swelling more effectively than some other treatments. Photobiomodulation therapy (PBMT), also known as low-level laser therapy, has shown potential to lessen pain and disability in tendinopathy cases. This trial will test the combination of SWT and PBMT with physical therapy to determine if it improves symptoms of Achilles tendinopathy. ^{2 5 6 7 8}

Who Is on the Research Team?

Jeremy D Schroeder

Principal Investigator

Madigan Army Medical Center

Are You a Good Fit for This Trial?

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

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 experience ongoing or recurring pain, numbness, or tingling in my lower body due to sciatica.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PT + Shockwave Therapy (SWT) Active Control 2 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 PBMT Active Control 3 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) Only Active Control 1 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 Control 2 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.

Who Is Running the Clinical Trial?

Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Lead Sponsor

Trials

4

Recruited

280+

The Geneva Foundation

Collaborator

Trials

39

Recruited

13,700+

Fort Belvoir Community Hospital

Collaborator

Trials

15

Recruited

2,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6860369/

Immediate effect of photobiomodulation therapy on Achilles ... Conclusion: When treated with a laser-induced PBM treatment, healthy and pathologic Achilles tendons do not have immediate (within 4 hours) changes in tendon ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8364035/

The effect of low-level red and near-infrared ... There is very-low-to-moderate quality evidence demonstrating that PBM has utility as a standalone and/or adjunctive therapy for tendinopathy disorders.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590109522000477

Photobiomodulation Associated With Conservative ... Main Outcome Measures. Primary outcome was the Achilles Tendon Rupture Score. Secondary outcomes included Numerical Pain Rating Scale at rest and during effort, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05751785

Shockwave, Photobiomodulation, and Physical Therapy for ... Overall, studies indicate that ESWT and photobiomodulation therapy (PBMT) will be effective in treating tendon injuries such as AT, however, these treatment ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/9/e059479

Efficacy of low-level laser therapy in patients with lower ... LLLT significantly reduces pain and disability in lower extremity tendinopathy and plantar fasciitis in the short and medium term.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32204620/

Photobiomodulation with low-level laser therapy for ... Conclusion: The certainty of evidence was low to very low, and the results are insufficient to support the routine use laser therapy for Achilles tendinopathy.

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/0269215520912820

Photobiomodulation with low-level laser therapy ... The purpose of this study was to determine the benefits and harms of low-level laser therapy for Achilles tendinopathy.

8. liebertpub.com liebertpub.com/doi/10.1089/photob.2021.0192

Photobiomodulation for Tendinopathy: A Review of ... Data revealed that most of the studies (86%, 19/22) reported significant outcomes of laser Photobiomodulation in the healing of injured rat ...