N/A
N=46
Shockwave, Photobiomodulation, and Physical Therapy for Achilles Tendinopathy
Achilles Tendinopathy
Bottom Line
View on ClinicalTrials.gov: NCT05751785 ↗Enrolled (actual)
46
Serious AEs
17.8%
Results posted
Jul 2025
Primary outcome: Primary: Victorian Institute of Sports Assessment - Achilles (VISA-A) — 37.55; 43.82; 36.08; 46.92 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Physical Therapy (Other); Shockwave Therapy (Device); Photobiomodulation Therapy (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Musculoskeletal Injury Rehabilitation Research for Operational Readiness
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Victorian Institute of Sports Assessment - Achilles (VISA-A) |
67.50; 76.11; 61.22; 69 | — |
| PRIMARY Victorian Institute of Sports Assessment - Achilles (VISA-A) |
67.50; 76.11; 61.22; 69 | — |
| PRIMARY Victorian Institute of Sports Assessment - Achilles (VISA-A) |
67.50; 76.11; 61.22; 69 | — |
| PRIMARY Victorian Institute of Sports Assessment - Achilles (VISA-A) |
67.50; 76.11; 61.22; 69 | — |
| PRIMARY Victorian Institute of Sports Assessment - Achilles (VISA-A) |
67.50; 76.11; 61.22; 69 | — |
| PRIMARY Lower Extremity Functional Scale (LEFS) |
62.38; 64.89; 62.33; 67.10 | — |
| PRIMARY Lower Extremity Functional Scale (LEFS) |
62.38; 64.89; 62.33; 67.10 | — |
| PRIMARY Lower Extremity Functional Scale (LEFS) |
62.38; 64.89; 62.33; 67.10 | — |
| PRIMARY Lower Extremity Functional Scale (LEFS) |
62.38; 64.89; 62.33; 67.10 | — |
| PRIMARY Lower Extremity Functional Scale (LEFS) |
62.38; 64.89; 62.33; 67.10 | — |
| PRIMARY Defense and Veteran's Pain Rating Scale (DVPRS) |
1.88; 1.67; 2.11; 2.60 | — |
| PRIMARY Defense and Veteran's Pain Rating Scale (DVPRS) |
1.88; 1.67; 2.11; 2.60 | — |
| PRIMARY Defense and Veteran's Pain Rating Scale (DVPRS) |
1.88; 1.67; 2.11; 2.60 | — |
| PRIMARY Defense and Veteran's Pain Rating Scale (DVPRS) |
1.88; 1.67; 2.11; 2.60 | — |
| PRIMARY Defense and Veteran's Pain Rating Scale (DVPRS) |
1.88; 1.67; 2.11; 2.60 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index (UWRI) |
16.25; 20.78; 19.11; 20.20 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index (UWRI) |
16.25; 20.78; 19.11; 20.20 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index (UWRI) |
16.25; 20.78; 19.11; 20.20 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index (UWRI) |
16.25; 20.78; 19.11; 20.20 | — |
| PRIMARY University of Wisconsin Running Injury and Recovery Index (UWRI) |
16.25; 20.78; 19.11; 20.20 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
42.94; 45.47; 55.58; 43.95; 43.24; 44.07 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
42.94; 45.47; 55.58; 43.95; 43.24; 44.07 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
42.94; 45.47; 55.58; 43.95; 43.24; 44.07 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
42.94; 45.47; 55.58; 43.95; 43.24; 44.07 | — |
| PRIMARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
42.94; 45.47; 55.58; 43.95; 43.24; 44.07 | — |
| PRIMARY Cross-sectional Area |
0.67; 0.71; 0.62; 1.50 | — |
| PRIMARY Cross-sectional Area |
0.67; 0.71; 0.62; 1.50 | — |
| PRIMARY Cross Sectional Area |
0.76; 0.74; 0.70; 0.80 | — |
| PRIMARY Width |
.63; .65; .59; .68 | — |
| PRIMARY Width |
.63; .65; .59; .68 | — |
| PRIMARY Width |
.63; .65; .59; .68 | — |
| PRIMARY Degree of Thickening |
1.45; 1.53; 1.37; 1.55 | — |
| PRIMARY Degree of Thickening |
1.45; 1.53; 1.37; 1.55 | — |
| PRIMARY Degree of Thickening |
1.45; 1.53; 1.37; 1.55 | — |
| PRIMARY Relative Neovascularity |
.88; .56; .89; .60 | — |
| PRIMARY Relative Neovascularity |
.88; .56; .89; .60 | — |
| PRIMARY Relative Neovascularity |
.88; .56; .89; .60 | — |
| PRIMARY Elastography |
6.63; 6.76; 6.34; 6.89 | — |
| PRIMARY Elastography |
6.63; 6.76; 6.34; 6.89 | — |
| PRIMARY Elastography |
6.63; 6.76; 6.34; 6.89 | — |
| PRIMARY Heel Raises-Quantitative Function in Heel Raises to Fatigue. |
22.13; 21.44; 20.22; 21.90 | — |
| PRIMARY Heel Raises-Quantitative Function in Heel Raises to Fatigue. |
22.13; 21.44; 20.22; 21.90 | — |
| PRIMARY Heel Raises-Quantitative Function in Heel Raises to Fatigue. |
22.13; 21.44; 20.22; 21.90 | — |
| PRIMARY Hops |
.88; 2.38; 3.00; 2.10 | — |
| PRIMARY Hops |
.88; 2.38; 3.00; 2.10 | — |
| PRIMARY Hops |
.88; 2.38; 3.00; 2.10 | — |
| PRIMARY Ankle Range of Motion (ROM) |
15.75; 10.22; 10.67; 11.60 | — |
| PRIMARY Ankle Range of Motion (ROM) |
15.75; 10.22; 10.67; 11.60 | — |
| PRIMARY Ankle Range of Motion (ROM) |
15.75; 10.22; 10.67; 11.60 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05751785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.