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

Not Applicable

Active, not recruiting

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

• Registration Number: NCT04725513
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

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 Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-26
• Study Start: 2022-08-29
• Primary Completion: 2024-09-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Photobiomodulation, Shockwave Therapy and Physical Therapy	Physical Therapy	-
Physical Therapy Only	Physical Therapy	-
Shockwave Therapy and Physical Therapy	Physical Therapy	-
Shockwave Therapy and Physical Therapy	Shockwave Therapy	-
Photobiomodulation, Shockwave Therapy and Physical Therapy	Shockwave Therapy	-
Photobiomodulation, Shockwave Therapy and Physical Therapy	Photobiomodulation Therapy	-

Primary Outcome Measures

Name	Time	Method
Ultrasound measurements	0-6 months	The cross-sectional area will be measure on the ultrasound
Victorian Institute of Sports Assessment (VISA-A) Questionnaire	0-6 months	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).
Calf raises to fatigue	0-6 months	The number of calf raises to fatigue that the participant is able to be performed by will be recorded at different time points

Trial Locations

Locations (1)

Spaulding Hospital Cambridge; 🇺🇸 Cambridge, Massachusetts, United States