Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy

Not Applicable

Completed

• Conditions: Achilles Tendinopathy
• Interventions: Other: Physical Therapy; Device: Shockwave Therapy; Device: Photobiomodulation Therapy

• Registration Number: NCT05751785
• Lead Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Brief Summary

The goal of this clinical trial is to learn more about and compare the effectiveness of standard of care (SOC) physical therapy (PT), PT with photobiomodulation therapy (PBMT; low-level laser therapy), PT with shockwave therapy (SWT; high-energy acoustic wave therapy), and PT with PBMT and SWT, to improve function, decrease pain, and resolve symptoms in individuals with non-insertional Achilles tendinopathy. The main question it aims to answer is:

• What is the most effective treatment method for non-insertional Achilles tendinopathy?

Participants will

Researchers will compare PT, PT + SWT, PT + SWT and PBMT to assess the most effective treatment for Achilles tendinopathy.

Detailed Description

Non-insertional Achilles Tendinopathy (AT) is a common overuse injury in adults who are both athletes and nonactive. Tendinopathy occurs when there is either a failed healing response or the failure of normal turnover or remodeling response, and results in pain and limited movement. In the military, lower-extremity injuries due to overuse, (e.g., AT) are the most common category of injuries. The most common treatment of choice for AT is exercise loading programs, however eccentric strengthening (ECC) may only improve symptoms in approximately 60% of patients. Laser-induced photobiomodulation (PBM) has been shown to increase cell proliferation and metabolism, which may aid in the repair and remodeling process. Studies have found that PBM was effective in the treatment of AT. Extracorporeal shockwave therapy (ESWT) is a process in which energy is delivered to the muscles or tendons for pain relief. Current literature supports the use of ESWT as an effective treatment for AT in combination with ECC. Overall, studies indicate that ESWT and photobiomodulation therapy (PBMT) will be effective in treating tendon injuries such as AT, however, these treatment methods have not been evaluated in comparison or combination with each other. The sub-section of AT amongst Active-Duty personnel has very limited research and given the high prevalence, should be addressed. Therefore, our study will compare three different treatment arms utilizing traditional physical therapy (PT), PT plus ESWT, PT plus PBMT, and PT plus ESWT and PBMT. Both self-reported questionnaires and measured outcomes will be used to assess the most effective treatment for AT.

Study Timeline

• Study First Submitted: 2023-01-27
• Study Start: 2023-02-13
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-02
• Primary Completion: 2024-11-14
• Study Completion: 2024-11-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PT + SWT and PBMT	Photobiomodulation Therapy	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).
PT + Photobiomodulation Therapy (PBMT)	Physical Therapy	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.
PT + Photobiomodulation Therapy (PBMT)	Photobiomodulation Therapy	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.
PT + Shockwave Therapy (SWT)	Shockwave Therapy	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.
Physical Therapy (PT) Only	Physical Therapy	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).
PT + Shockwave Therapy (SWT)	Physical Therapy	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.
PT + SWT and PBMT	Shockwave Therapy	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).
PT + SWT and PBMT	Physical Therapy	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).

Primary Outcome Measures

Name	Time	Method
Victorian Institute of Sports Assessment - Achilles (VISA-A)	6-month	Symptoms severity specific to Achilles will be Victorian Institute of Sports Assessment - Achilles (VISA-A). The VISA-A is currently the only valid and reliable measure to assess function and pain in AT (validity, P\<0.01; test-re-test reliability, r = 0.98). Rating scale between 0-10.
University of Wisconsin Running Injury and Recovery Index (UWRI)	6-month	The University of Wisconsin Running Injury and Recovery Index (UWRI)will measure aspects unique to returning to running. Rating scale from 0-4.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)	6-month	Patient-Reported Outcomes Measurement Information System (PROMIS-29) will be used to capture other aspects of non-disease specific measures of health-related domains (physical, mental and social health). Rating scale from 1-5.
Width	6-month	Measures of interest include width of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Degree of thickening	6-month	Measures of interest include degree of thickening of tendon. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Lower Extremity Functional Scale (LEFS)	6-month	Lower Extremity Functional Scale (LEFS) will capture functional status. Rating scale from 0-4.
Elastography	6 Months	Measures of interest include elastography. A study team member will assess ultrasound measures at baseline for both limbs. The elastography evaluation should be conducted in two orthogonal planes at the area of maximal thickness/width, IAW manufacture guidance on elastography image collections.
Ankle range of motion	6 Months	Quantitative function in range of motion. Ankle- dorsiflexion and plantar flexion range of motion (ROM), both active and passive, will be; measured using a goniometer.
Defense and Veteran's Pain Rating Scale (DVPRS)	6-month	Defense and Veteran's Pain Rating Scale (DVPRS)will capture pain; basic applied after hop test and supplemental provided at each visit. Rating scale from 0-10.
Relative neovascularity	6-months	Measures of interest include relative neovascularity. A study team member will assess ultrasound measures at baseline for both limbs. The relative level of neovascularization will be rated from grade 0: no visible vessels, grade 2: 3 to 5 vessels within the region of interest (ROI), grade 3: vessel's in up to 30% of the ROI
Cross-sectional area	12-week	Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Cross Sectional area	6-month	Measures of interest include cross-sectional area. A study team member will assess ultrasound measures at baseline for both limbs, measured in centimeters (cm).
Heel raises-Quantitative function in heel raises to fatigue.	6 Months	Quantitative function in heel raises to fatigue on both limbs.
Hops	6 Months	Quantitative function in ankle strength, we will also ask the participants to complete 20 hops and rate their pain using the Defense and Veteran's Pain Rating Scale (DVPRS).

Trial Locations

Locations (1)

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States