Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment
BFR
1 other identifier
interventional
104
1 country
1
Brief Summary
The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedFebruary 8, 2022
February 1, 2022
2.2 years
October 13, 2020
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Numerical Pain Rating Scale
Change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain
Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Patient-rated tennis elbow evaluation (PRTEE)
Change in score of the patient reported outcome measure (form): rating pain as well as difficulty on a scale of 0-10 with certain movements and functional activities. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.
Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Grip Strength
Assessing change in grip strength using the JAMAR dynamometer- taken with elbow straight, average of 3 measurements recorded.
Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions
Secondary Outcomes (1)
Patient-Reported Outcome Measurement Information System version 1.2- Global Health
Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Study Arms (2)
Evidence-informed care
ACTIVE COMPARATORStandardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises.
Evidence-informed care + Blood Flow Restriction (BFR)
EXPERIMENTALStandardized, evidence based rehabilitation program for lateral epicondylalgia to include: discussion of ergonomics, home exercise program performance, use of any prescribed splint or brace, forearm and shoulder stretches, soft tissue mobilization, and performance of standard resistance exercises with the addition of BFR while performing resistive exercises.
Interventions
The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The external constriction device will be applied to the proximal aspect of an individual's limb to restrict the flow of blood into and out of the extremity at 50% of usual flow. Subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist. The Delphi PTS cuff is inflated at the start of the exercise and remains inflated throughout the exercise. Once the participant has completed an exercise, the cuff is deflated for 1 minute and the same cycle is performed for each subsequent exercise.
Evidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia.
Eligibility Criteria
You may qualify if:
- Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)
- Between the ages of 18-65
- Elbow pain for 4 weeks or more
You may not qualify if:
- Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.
- Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- Current fracture in affected arm
- History of crush injury to affected arm
- Any surgery on affected arm in last 1 year
- Surgery within last year on contralateral upper extremity
- History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
- Pregnancy
- Active infection
- Current cancer diagnosis/treatment
- Sickle cell anemia or trait
- Kidney dialysis
- History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
- Inability to consent
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navy Medical Readiness & Training Command San Diego
San Diego, California, 92134, United States
Related Publications (6)
Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PMID: 28259850RESULTLoenneke JP, Wilson JM, Wilson GJ, Pujol TJ, Bemben MG. Potential safety issues with blood flow restriction training. Scand J Med Sci Sports. 2011 Aug;21(4):510-8. doi: 10.1111/j.1600-0838.2010.01290.x. Epub 2011 Mar 16.
PMID: 21410544RESULTAmerican College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PMID: 19204579RESULTSlysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.
PMID: 26463594RESULTYasuda T, Brechue WF, Fujita T, Shirakawa J, Sato Y, Abe T. Muscle activation during low-intensity muscle contractions with restricted blood flow. J Sports Sci. 2009 Mar;27(5):479-89. doi: 10.1080/02640410802626567.
PMID: 19253083RESULTDay JM, Lucado AM, Uhl TL. A COMPREHENSIVE REHABILITATION PROGRAM FOR TREATING LATERAL ELBOW TENDINOPATHY. Int J Sports Phys Ther. 2019 Sep;14(5):818-829.
PMID: 31598419RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tara Haugen, MSOT
United States Naval Medical Center, San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- LT, Physical Therapist
Study Record Dates
First Submitted
October 13, 2020
First Posted
October 29, 2020
Study Start
March 1, 2021
Primary Completion
May 15, 2023
Study Completion
June 30, 2023
Last Updated
February 8, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share