- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07007455
- Original Trial
Effectiveness of Wrist Extensor Strength Training With Blood Flow Restriction on Lateral Elbow Tendinopathy (BFR)
Study Overview
Status
Conditions
Detailed Description
Lateral epicondylitis is a work-related musculoskeletal disorder and is defined as persistent symptomatic degeneration of the wrist extensor muscle tendon that connects to the lateral humeral epicondyle. It is characterized by pain on the lateral side of the elbow joint, limited range of motion, and weakness in the forearm muscles.
Management of lateral epicondylitis is aimed at reducing pain and discomfort, preserving ROM, and enhancing the strength and endurance of the affected limb by using numerous techniques, including electrophysical methods and physical activity.
Blood flow restriction training (BFRT) involves partially restricting arterial blood flow into muscles while occluding venous outflow during exercise. It was first introduced into the literature in 1987 by researchers who used tourniquet ischemia to induce fatigue in muscles, dating back to Dr. Yoshiaki Sato in Japan, where it was known as "kaatsu training," meaning "training with added pressure." Kaatsu training is now performed worldwide and is more commonly referred to as "BFR training," which is achieved using a pneumatic tourniquet system.
In addition to physical rehabilitation, BFRT is used for physical training and performance in healthy individuals. There has been extensive research into its value as a training tool, including elite- and amateur-level athletes, untrained young and older adults, and hypertensive individuals.
In addition to reducing arterial blood flow to working muscles, blood flow restriction obstructs venous return. When active muscles are exposed to BFR conditions, they are subjected to ischemia, which increases the metabolic stress on them. In addition to BFR, venous occlusion increases muscle cell swelling, activates intracellular anabolic pathways, and recruits fast-twitch fibers, which are thought to be involved in muscle adaptation.
There were different Factors affecting exercise adaptations with BFR, including pressure of occlusion (partial or complete), type of occlusion (continuous or intermittent), intensity of exercise, and volume of
Exercise with BFR:
BFR, along with low-load resistance training, cardio endurance training, and other activities that are generally recommended to improve muscular mass/strength, is also associated with these adaptations in muscles.
The randomized trial done by Karanasios et al to assess the effect of low-load resistance training with blood flow restriction (LLRT-BFR) versus LLRT with sham-BFR in patients with lateral elbow tendinopathy (LET) found that LLRT with blood flow restriction produced significantly better pain, strength, and function improvement in comparison to LLRT with sham-BFR for all primary outcomes(Karanasios et al., 2022).
Regarding the study of proximal and distal effects of BFR Training, a study by Bowman et al. on Lower extremity Low-load BFR training resulted in greater increases in muscle strength and limb circumference in healthy participants after completing a standardized 6-week course of BFR training. Muscle groups at the proximal and distal ends of the body were similarly strengthened after BFR training(Bowman et al., 2019).
This study aims to explore the effects of incorporating BFR into wrist extensor strength training for athletes with lateral epicondylitis. By evaluating its impact on strength, function, pain, range of motion (ROM), and overall quality of life, this research seeks to determine whether BFR can optimize rehabilitation outcomes and provide a more effective treatment strategy for LET.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Al Riyadh
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Al Majma'ah, Al Riyadh, Saudi Arabia, 11952
- Health Rehabiltation Center
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Al-Riyadh
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Al Majma'ah, Al-Riyadh, Saudi Arabia, Majmaah University
- Majmaah University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both Male and female, aged between 18 to 45 years old.
- Subjects with a positive test of lateral epicondylitis, which will be determined based on physical therapy assessment procedures.
- The presence of tenderness over the lateral epicondyle.positive Cozen's and Mill's tests.
- Pain on grasping.
- Pain on passive flexion of the wrist with elbow extension.
- Pain with resisted wrist extension.
- Show decreased muscle strength and functional ability.
Exclusion Criteria:
- Patients with shoulder tendinopathy, cervical radiculopathy, and rheumatoid arthritis.
- Presences of sensory and motor impairment of the upper extremities
- History of cardiovascular disease
- History of trauma and surgery on the elbow
- Having a history of malignancy and peripheral vascular disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group: wrist extensor strength training with BFR.
Experimental Group: Participants will undergo wrist extensor strength training with blood flow restriction (BFR).
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Wrist extensor strength training without BFR.
Other Names:
|
|
Active Comparator: Control Group: Wrist extensor strength training without BFR.
Control Group: Participants will undergo the same wrist extensor strength training without blood flow restriction (BFR).
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wrist extensor strength training without BFR.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pressure pain thresholds (PPTs).
Time Frame: six weeks
|
before and after intervention.
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six weeks
|
|
pain-free grip strength test
Time Frame: six weeks
|
before and after intervention.
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six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Borg 6-20 scale
Time Frame: six weeks
|
Participants will be asked to rate their effort after each set of exercises on a scale from 6 (no exertion) to 20 (maximal exertion).
|
six weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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