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

Mass General Brigham

Status: Completed

Conditions: Achilles Tendinopathy

Treatments: Other: Physical Therapy; Device: Shockwave Therapy; Device: Photobiomodulation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04725513

2021P000025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

46 participants in 3 patient groups

Physical Therapy Only

Active Comparator group

Treatment:

Other: Physical Therapy

Shockwave Therapy and Physical Therapy

Experimental group

Treatment:

Device: Shockwave Therapy

Other: Physical Therapy

Photobiomodulation, Shockwave Therapy and Physical Therapy

Experimental group

Treatment:

Device: Photobiomodulation Therapy

Device: Shockwave Therapy

Other: Physical Therapy