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

January 9, 2026 updated by: Adam Tenforde, Spaulding Rehabilitation Hospital

Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, a Combination of Shockwave Therapy and Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy: A Randomized Control Trial With Elective Cross-Over Design

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Spaulding Hospital Cambridge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Physical Therapy Only
Other: Physical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol
Experimental: Shockwave Therapy and Physical Therapy
Other: Physical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol
Device: Shockwave Therapy
Participants will receive shockwave therapy once a week for three weeks
Experimental: Photobiomodulation, Shockwave Therapy and Physical Therapy
Other: Physical Therapy
Participants will enroll in physical therapy and complete an at-home exercise protocol
Device: Shockwave Therapy
Participants will receive shockwave therapy once a week for three weeks
Device: Photobiomodulation Therapy
Participants will receive photobiomodulation therapy twice a week for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calf Raises Performed to Fatigue and Inability to Continue
Time Frame: Difference from 0-3 months
Calf raises performed to fatigue and inability to continue
Difference from 0-3 months
Ultrasound Measurements in Change of Cross Sectional Area
Time Frame: Difference from 0-3 months
Changes in the cross-sectional area measured on ultrasound
Difference from 0-3 months
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
Time Frame: change from baseline to 3 month follow-up measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2022

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021P000025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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