Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy

NCT04725513 | Completed Results FDA Device

• 1 other identifier: 2021P000025
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (3)

• Calf Raises Performed to Fatigue and Inability to Continue

  Calf raises performed to fatigue and inability to continue

  Difference from 0-3 months

• Ultrasound Measurements in Change of Cross Sectional Area

  Changes in the cross-sectional area measured on ultrasound

  Difference from 0-3 months

• Victorian Institute of Sports Assessment (VISA-A) Questionnaire

  Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better).

  change from baseline to 3 month follow-up measure

Study Arms (3)

Physical Therapy Only

ACTIVE COMPARATOR

Other: Physical Therapy

Shockwave Therapy and Physical Therapy

EXPERIMENTAL

Device: Shockwave Therapy; Other: Physical Therapy

Photobiomodulation, Shockwave Therapy and Physical Therapy

EXPERIMENTAL

Device: Shockwave Therapy; Device: Photobiomodulation Therapy; Other: Physical Therapy

Interventions

Physical Therapy OTHER

Participants will enroll in physical therapy and complete an at-home exercise protocol

Photobiomodulation, Shockwave Therapy and Physical Therapy; Physical Therapy Only; Shockwave Therapy and Physical Therapy

Shockwave Therapy DEVICE

Participants will receive shockwave therapy once a week for three weeks

Photobiomodulation, Shockwave Therapy and Physical Therapy; Shockwave Therapy and Physical Therapy

Photobiomodulation Therapy DEVICE

Participants will receive photobiomodulation therapy twice a week for three weeks

Photobiomodulation, Shockwave Therapy and Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
• Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running
• VISA-A \<80 at baseline to be eligible

You may not qualify if:

• Less than 3 months of symptoms
• Primary insertional Achilles tendinopathy
• Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT
• Have received SWT within the past 3 months to their Achilles
• Prior injection within 3 months
• Currently enrolled in PT for more than 4 weeks for their condition
• Women who are pregnant.
• known history of Achilles tendon tear
• currently taking oral steroid or fluoroquinolone class of antibiotics

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (2)

• Tenforde AS, Pham L, Gaudette LW, Funk MM, Vogel KE, Bruneau MM, Yuan X, Schroeder JD, Isaacson B, Hagar N, Metzger E, Nolan DC, Tam J, Silbernagel KG. Exercise, radial pressure waves, and photobiomodulation for management of non-insertional Achilles tendinopathy in runners: a three-arm non-blinded randomised control trial. BMJ Open Sport Exerc Med. 2025 Oct 5;11(4):e002442. doi: 10.1136/bmjsem-2024-002442. eCollection 2025.

  PMID: 41070206 DERIVED

• Tenforde AS, Vogel KEL, Tam J, Silbernagel KG. Research protocol to evaluate the effectiveness of shockwave therapy, photobiomodulation and physical therapy in the management of non-insertional Achilles tendinopathy in runners: a randomised control trial with elective cross-over design. BMJ Open Sport Exerc Med. 2022 Sep 27;8(3):e001397. doi: 10.1136/bmjsem-2022-001397. eCollection 2022.

  PMID: 36187084 DERIVED

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Low-Level Light Therapy; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Rehabilitation; Laser Therapy; Phototherapy

Results Point of Contact

• Title: Adam Tenforde, MD
• Organization: Spaulding Rehabilitation Hospital

atenforde@mgh.harvard.edu

6179526800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first part of the study is a randomized control trial, the second part is an elective cross over

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 26, 2021
• Study Start: August 29, 2022
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 12, 2026
• Results First Posted: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)