Achilles TendinopathyNCT03264326
Efficacy of BFR Training Combined With Eccentric Exercise as Assessed by SWE in Subjects With Chronic AT
A study testing Blood Flow Restriction Training and Eccentric Exercise in people with Achilles Tendinopathy, run by Womack Army Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Blood Flow Restriction Training and Eccentric Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
About this study
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
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.
- Conditions
- Achilles Tendinopathy
- Being tested
- Blood Flow Restriction Training, Sham Blood Flow Restriction Training, Eccentric Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingOther
Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
Sham Blood Flow Restriction TrainingOther
Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.
Eccentric ExerciseOther
Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
| Study group | Role | What they receive |
|---|---|---|
| BFR Group | Experimental | Blood Flow Restriction Training with Eccentric Exercise Protocol Receives: Other: Blood Flow Restriction Training; Other: Eccentric Exercise |
| Sham BFR Group | Sham comparator | Sham Blood Flow Restriction Training with Eccentric Exercise Protocol Receives: Other: Sham Blood Flow Restriction Training; Other: Eccentric Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Wave Elastography velocity
Difference between involved and uninvolved Achilles tendon
Measured: At baseline.
VISA-A
Change in subjective self-report of Achilles function
Measured: From baseline to 24 weeks
Secondary outcomes (8)
Triple hop test
Distance in length of 3 consecutive hops on one foot
Measured: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Calf Raise Endurance
Number of single leg calf raises to failure
Measured: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Jump Height
Distance in height of single leg jump
Measured: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Thigh Circumference
circumferential measurement of thigh
Measured: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Calf Circumference
circumferential measurement of calf
Measured: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Numerical Pain Rating Scale
Pain level on a 0 to 10 scale
Measured: At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Global Rating of Change
15 point Likert scale from -7 to +7
Measured: At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Shear Wave Elastography velocity
Change in shear wave elastography of symptomatic Achilles tendon over time.
Measured: Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start26 Oct 2017
- Primary completion5 Sep 2018
- Study completion30 Dec 2018
Why it stopped: Principal Investigator left institution and not enough resources to support at MTF
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Womack Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- The Geneva Foundation, Telemedicine & Advanced Technology Research Center
- Responsible party
- Sponsor
- Investigators
- Robert A Whitehurst, DPT, Principal investigator, Womack Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264326
- Sponsor's protocol ID
- 161202
- Status last verified
- May 2019
- First submitted
- 2 Aug 2017
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03264326
- Acronym / sponsor ID
- 161202
- Conditions
- Achilles Tendinopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution and not enough resources to support at MTF
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Womack Army Medical CenterUS federal agency
- Collaborators
- The Geneva Foundation, Telemedicine & Advanced Technology Research Center
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR Group | Experimental | Other: Blood Flow Restriction Training, Other: Eccentric ExerciseBlood Flow Restriction Training with Eccentric Exercise Protocol |
| Sham BFR Group | Sham comparator | Other: Sham Blood Flow Restriction Training, Other: Eccentric ExerciseSham Blood Flow Restriction Training with Eccentric Exercise Protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction TrainingDelfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise. | Other | BFR Group |
| Sham Blood Flow Restriction TrainingDelfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment. | Other | Sham BFR Group |
| Eccentric ExerciseSubjects perform eccentric calf lowering off a step for 90 repetitions twice daily. | Other | BFR Group, Sham BFR Group |
Primary outcome
Shear Wave Elastography velocity
Time frame: At baseline.
Difference between involved and uninvolved Achilles tendon
VISA-A
Time frame: From baseline to 24 weeks
Change in subjective self-report of Achilles function
8 secondary outcomes
Triple hop test
Time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Calf Raise Endurance
Time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
SL Jump Height
Time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Thigh Circumference
Time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Calf Circumference
Time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, and 12 weeks.
Numerical Pain Rating Scale
Time frame: At baseline, then at 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Global Rating of Change
Time frame: At 3 weeks, 6 weeks, 9 weeks, 12 weeks and 24 weeks.
Shear Wave Elastography velocity
Time frame: Baseline, at 3 weeks, 6 weeks, 9 weeks, 12 weeks.
Results and safety
The study was stopped early (reason given: Principal Investigator left institution and not enough resources to support at MTF). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A Whitehurst, DPT principal investigator
Womack Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training and Eccentric Exercise in people with Achilles Tendinopathy, run by Womack Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator left institution and not enough resources to support at MTF). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Elastography velocity (time frame: At baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.