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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2024-10-01

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.

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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.

Conditions

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Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The first part of the study is a randomized control trial, the second part is an elective cross over

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physical Therapy Only

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type OTHER

Participants will enroll in physical therapy and complete an at-home exercise protocol

Shockwave Therapy and Physical Therapy

Group Type EXPERIMENTAL

Shockwave Therapy

Intervention Type DEVICE

Participants will receive shockwave therapy once a week for three weeks

Physical Therapy

Intervention Type OTHER

Participants will enroll in physical therapy and complete an at-home exercise protocol

Photobiomodulation, Shockwave Therapy and Physical Therapy

Group Type EXPERIMENTAL

Shockwave Therapy

Intervention Type DEVICE

Participants will receive shockwave therapy once a week for three weeks

Photobiomodulation Therapy

Intervention Type DEVICE

Participants will receive photobiomodulation therapy twice a week for three weeks

Physical Therapy

Intervention Type OTHER

Participants will enroll in physical therapy and complete an at-home exercise protocol

Interventions

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Shockwave Therapy

Participants will receive shockwave therapy once a week for three weeks

Intervention Type DEVICE

Photobiomodulation Therapy

Participants will receive photobiomodulation therapy twice a week for three weeks

Intervention Type DEVICE

Physical Therapy

Participants will enroll in physical therapy and complete an at-home exercise protocol

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No