The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.

Study Overview
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Brief Summary
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A randomized cross-over trial comparing the immediate effects of a wrist extensor exercise with and without blood flow restriction (BFR) on pain perception in patients with lateral elbow tendinopathy (LET).

Detailed Description
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Patients with LET will participate in the study performing an exercise with and without blood flow restriction (BFR) in a randomized order (two occasions). A target of 20 patients for enrollment has been set for 80% power, p<0.05 (Effect size= 1). Two interventions will be used lasting 40 minutes each. Intervention: A wrist extension exercise (concentric-eccentric) with Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (<2/10 in numerical pain rating scale). Control Group: A wrist extension exercise (concentric-eccentric) without Blood Flow Restriction (30-15-15-15 reps). Exercises will be performed using dumbbells according to a pain monitoring approach (<2/10 in numerical pain rating scale). Primary outcomes: pressure pain thresholds lateral epicondyle, cervical spine and tibialis anterior (bilateral). Secondary outcome: pain free grip strength

Official Title
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The Immediate Effects of a Wrist Extensors Exercise With Blood Flow Restriction BFR in Lateral Elbow Tendinopathy. A Randomized Controlled Trial.

Conditions
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Lateral Epicondylitis

Intervention / Treatment
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* Other: Exercise with Blood Flow Restriction (BFR)
* Other: Exercise without Blood Flow Restriction (BFR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women diagnosed with Lateral Elbow Tendinopathy (LET) Symptoms for over 2 weeks Pain provoked by palpation on the lateral epicondyle Positive: Cohen's test, Maudsley test, Mill's test decrease in pain grip strength >5% in elbow extension compared to flexion Exclusion Criteria: Shoulder tendinopathy Cervical radiculopathy Rheumatoid arthritis Neurological deficit Radial nerve entrapment Past treatment for the elbow before entering the study Professional athletes Lateral elbow tendinopathy of the same side in the last 3 years Serious cardiovascular diseases Venous deficiency History of heart surgery Cancer history Breast surgery Orthopaedic surgeries during the last 6 months Thrombosis Body mass Index ≥ 30 Crohn syndrome Family or personal history of pulmonary embolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wrist extensor exercise with Blood Flow Restriction<br>Blood flow restriction training. Patients will execute a wrist extension exercise on standing position with the elbow extended. The load (dumbbells) will be set according to a pain monitoring approach ( exercise should not provoke pain >2/10) during wrist extension. Load is increased by 0.5 to 1kg. We will allow a 30 sec break. The session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France). An 40% occlusion pressure is set and subjects perform 4 sets of wrist extension (30-15-15-15 reps). | Other: Exercise with Blood Flow Restriction (BFR)<br>* Wrist extensor exercise (concentric - eccentric) with BFR. BFR involves the reduction of blood flow to working skeletal muscle by applying a flexible cuff to the most proximal portions of a person's arms or legs that results in decreased arterial flow to the exercising muscle and occluded venous return back to the central circulation.<br>|
| Active Comparator: Wrist extensor exercise without Blood Flow Restriction<br>Patients will execute a wrist extension exercise on standing position with the elbow extended. The load (dumbbells) will be set according to a pain monitoring approach ( exercise should not provoke pain >2/10) during wrist extension. Load is increased by 0.5 to 1kg. We will allow a 30 sec break. | Other: Exercise without Blood Flow Restriction (BFR)<br>* Wrist extensor exercise (concentric - eccentric)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold | Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using bilateral sites on lateral epicondyle, cervical spine and tibialis anterior. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group. | Baseline and 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain free grip strength (PFGS) | 'Jamar' hand dynamometer was used, calculating the mean value (kilograms) of 3 efforts, separated by 30-second rest intervals with participants lying in supine position and the elbow fully extended | Baseline and 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tennis elbow, pain threshold, elbow tendinopathy, BFR, hypoalgesia