Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03264326
• Other study ID #: 161202
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

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.