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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-29

Study Completion Date

2024-05-31

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).

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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

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Wrist extensor exercise with Blood Flow Restriction

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).

Group Type EXPERIMENTAL

Exercise with Blood Flow Restriction (BFR)

Intervention Type OTHER

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.

Wrist extensor exercise without Blood Flow Restriction

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.

Group Type ACTIVE_COMPARATOR

Exercise without Blood Flow Restriction (BFR)

Intervention Type OTHER

Wrist extensor exercise (concentric - eccentric)

Interventions

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Exercise with Blood Flow Restriction (BFR)

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.

Intervention Type OTHER

Exercise without Blood Flow Restriction (BFR)

Wrist extensor exercise (concentric - eccentric)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No