Achilles Tendinopathy Clinical Trial
Official title:
Efficacy of Blood Flow Restriction Training Combined With Eccentric Exercise as Assessed by Shear Wave Elastography in Subjects With Chronic Achilles Tendinopathy: A Randomized Single Blinded Controlled Trial
Verified date | May 2019 |
Source | Womack Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this randomized controlled trial is to use Shear Wave Elastography (SWE) to assess Achilles tendinopathy and the effectiveness of Blood Flow Restriction (BFR) training in patients with Achilles tendinopathy as measured by Numeric Pain Rating Scale, functional self-report, and objective functional measures. SWE will be utilized to objectively quantify tendon properties and BFR training and eccentric exercise will be utilized to treat Achilles tendinopathy.
Status | Terminated |
Enrollment | 16 |
Est. completion date | December 30, 2018 |
Est. primary completion date | September 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Achilles pain for > 3 months - Unilateral symptoms only - DOD beneficiary, between the ages of 18 and 65 - Clinical diagnosis of Achilles tendinopathy - Read and speak English well enough to provide informed consent and follow study instructions. - Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks Exclusion Criteria: - Any disease or disease process that would preclude the participant from safely performing any of the exercises or intervention at the discretion of the PI. (Uncontrolled diabetes, cardiac disease, severe COPD, open wounds, current infection, etc.) - Any LE surgery on either side in the last 2 years - History of Achilles rupture - Any vascular disorder (varicose veins, Hx of DVT) - Leaving post/station in the following 3 months precluding them being able to come in for f/u visits - Self-report of pregnancy (currently or within last 6 months) - Other foot/LE disorder that prevents the completion of the eccentric exercises or BFR exercise - Unable/unwilling to hop on symptomatic leg - Pain < 2/10 of average pain on NPRS - VISA A score > 80% - Currently going through MEB/worker's comp |
Country | Name | City | State |
---|---|---|---|
United States | Womack Army Medical Center | Fort Bragg | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Womack Army Medical Center | Telemedicine & Advanced Technology Research Center, The Geneva Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blinding/Group assignment assessment | Question asking which group they believe they are in (interventional vs control) | At 12 weeks and 24 weeks. | |
Primary | Shear Wave Elastography velocity | Difference between involved and uninvolved Achilles tendon | At baseline. | |
Primary | VISA-A | Change in subjective self-report of Achilles function | From baseline to 24 weeks | |
Secondary | Triple hop test | Distance in length of 3 consecutive hops on one foot | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | |
Secondary | SL Calf Raise Endurance | Number of single leg calf raises to failure | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | |
Secondary | SL Jump Height | Distance in height of single leg jump | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | |
Secondary | Thigh Circumference | circumferential measurement of thigh | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | |
Secondary | Calf Circumference | circumferential measurement of calf | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | |
Secondary | Numerical Pain Rating Scale | Pain level on a 0 to 10 scale | At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. | |
Secondary | Global Rating of Change | 15 point Likert scale from -7 to +7 | At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. | |
Secondary | Shear Wave Elastography velocity | Change in shear wave elastography of symptomatic Achilles tendon over time. | Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks. |
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