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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03264326
Other study ID # 161202
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 26, 2017
Est. completion date December 30, 2018

Study information

Verified date May 2019
Source Womack Army Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood Flow Restriction Training
Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
Sham Blood Flow Restriction Training
Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.
Eccentric Exercise
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.

Locations

Country Name City State
United States Womack Army Medical Center Fort Bragg North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Womack Army Medical Center Telemedicine & Advanced Technology Research Center, The Geneva Foundation

Country where clinical trial is conducted

United States, 

Outcome

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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