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

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: Active, not recruiting
• Conditions: Achilles Tendinopathy
• Intervention / Treatment: Other: Physical Therapy; Device: Shockwave Therapy; Device: Photobiomodulation Therapy

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

• Study Contact: Name: Adam Tenforde, MD; Phone Number: 617-952-6808; Email: atenforde@partners.org
• Study Contact Backup: Name: Linh Pham; Phone Number: 6177242168; Email: lpham9@mgh.harvard.edu

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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 to fatigue	The number of calf raises to fatigue that the participant is able to be performed by will be recorded at different time points	0-6 months
Ultrasound measurements	The cross-sectional area will be measure on the ultrasound	0-6 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).	0-6 months

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 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 (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• 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