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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04725513
• Other study ID #: 2021P000025
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Device:
• Shockwave Therapy
Participants will receive shockwave therapy once a week for three weeks
• 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

Locations

Country	Name	City	State
United States	Spaulding Hospital Cambridge	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Ultrasound measurements	The cross-sectional area will be measure on the ultrasound	0-6 months
Primary	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