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

University of West Attica

Status: Invitation-only

Conditions: Lateral Epicondylitis

Treatments: Other: Exercise with Blood Flow Restriction (BFR); Other: Exercise without Blood Flow Restriction (BFR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05919914

11168 - 06/02/2023

Details and patient eligibility

About

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).

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Wrist extensor exercise with Blood Flow Restriction

Experimental group

Description:

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).

Treatment:

Other: Exercise with Blood Flow Restriction (BFR)

Wrist extensor exercise without Blood Flow Restriction

Active Comparator group

Description:

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.

Treatment:

Other: Exercise without Blood Flow Restriction (BFR)