Achilles Tendinopathy
Conditions
Brief summary
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.
Interventions
OTHERBlood Flow Restriction Training
Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.
OTHEREccentric Exercise
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
Sponsors
The Geneva Foundation
Telemedicine & Advanced Technology Research Center
Womack Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant blinded to group assignment, assessor blinded to group assignment, investigator blinded to analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shear Wave Elastography velocity | At baseline. | Difference between involved and uninvolved Achilles tendon |
| VISA-A | From baseline to 24 weeks | Change in subjective self-report of Achilles function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SL Calf Raise Endurance | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | Number of single leg calf raises to failure |
| SL Jump Height | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | Distance in height of single leg jump |
| Thigh Circumference | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | circumferential measurement of thigh |
| Calf Circumference | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | circumferential measurement of calf |
| Numerical Pain Rating Scale | At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. | Pain level on a 0 to 10 scale |
| Global Rating of Change | At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks. | 15 point Likert scale from -7 to +7 |
| Shear Wave Elastography velocity | Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks. | Change in shear wave elastography of symptomatic Achilles tendon over time. |
| Triple hop test | At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks. | Distance in length of 3 consecutive hops on one foot |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blinding/Group assignment assessment | At 12 weeks and 24 weeks. | Question asking which group they believe they are in (interventional vs control) |
Countries
United States
Outcome results
None listed