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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Achilles Tendinopathy

Intervention / Treatment
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* Device: Shockwave Therapy
* Device: Photobiomodulation Therapy
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The first part of the study is a randomized control trial, the second part is an elective cross over
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical Therapy Only<br> | Other: Physical Therapy<br>* Participants will enroll in physical therapy and complete an at-home exercise protocol<br>|
| Experimental: Shockwave Therapy and Physical Therapy<br> | Device: Shockwave Therapy<br>* Participants will receive shockwave therapy once a week for three weeks<br>Other: Physical Therapy<br>* Participants will enroll in physical therapy and complete an at-home exercise protocol<br>|
| Experimental: Photobiomodulation, Shockwave Therapy and Physical Therapy<br> | Device: Shockwave Therapy<br>* Participants will receive shockwave therapy once a week for three weeks<br>Device: Photobiomodulation Therapy<br>* Participants will receive photobiomodulation therapy twice a week for three weeks<br>Other: Physical Therapy<br>* Participants will enroll in physical therapy and complete an at-home exercise protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Ultrasound measurements | The cross-sectional area will be measure on the ultrasound | 0-6 months | 
| 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 |