Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
Achilles Tendinopathy
About this trial
This is an interventional treatment trial for Achilles Tendinopathy
Eligibility Criteria
Inclusion Criteria: DEERS Eligible Between the ages of 18-64 Currently Active Duty in any of the US Armed Forces Clinical diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral) by a healthcare provider based on accepted diagnostic criteria. Able to read and understand English language for consent purposes Able to commit to 3-weeks of intervention and 6-months of follow-up Exclusion Criteria: Primary insertional Achilles tendinopathy Platelet Rich Plasma (PRP), corticosteroid injection, or prolotherapy within 3 months Received dry needling within the past 4 weeks Previously completed the Silbernagel protocol for Achilles tendinopathy within the past 3 months Received SWT within the past 3 months to their Achilles Tattoo in the area of treatment (due to sensitivity to PBMT) Current use of pacemaker Patients with a known underlying cardiac disease that could be affected by SWT Patients with neuropathy affecting sensation to pain Current use of medications associated with sensitivity to heat or light (e.g. amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole) Current or chronic sciatica (lumbosacral radiculopathy) resulting in chronic or intermittent lower extremity pain, numbness, or tingling. Achilles tendon tear or prior Achilles tendon surgery Recent lower extremity injury within the last 3 months that required professional medical attention (e.g., ankle sprain, meniscus) Concurrent participation in another research study addressing pain issue Previously enrolled in the study for contralateral (opposite) leg Currently pregnant or plan to become pregnant during intervention period (safety of PBM not established in pregnancy) as determined by hCG urine test Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside of Achilles tendinopathy, or other contraindications to PBMT or SWT
Sites / Locations
- Madigan Army Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Physical Therapy (PT) Only
PT + Photobiomodulation Therapy (PBMT)
PT + Shockwave Therapy (SWT)
PT + SWT and PBMT
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).
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.
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.
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).