NCT04725513

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achilles Tendinopathy

Interventions

Type	Name	Description
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
OTHER	Physical Therapy	Participants will enroll in physical therapy and complete an at-home exercise protocol

Timeline

• Start date: 2022-08-29
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2021-01-26
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study