Clinical trial NCT04725513: Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Achilles Tendinopathy
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The first part of the study is a randomized control trial, the second part is an elective cross over
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Calf raises to fatigue
timeFrame: 0-6 months
measure: Ultrasound measurements
timeFrame: 0-6 months
measure: Victorian Institute of Sports Assessment (VISA-A) Questionnaire
timeFrame: 0-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Spaulding Hospital Cambridge
state: Massachusetts
Study officials:
References:
citation: 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.