The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.
- Conditions
- Lateral Epicondylitis
- Interventions
- Other: Exercise without Blood Flow Restriction (BFR)Other: Exercise with Blood Flow Restriction (BFR)
- Registration Number
- NCT05919914
- Lead Sponsor
- University of West Attica
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Wrist extensor exercise without Blood Flow Restriction Exercise without Blood Flow Restriction (BFR) 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. Wrist extensor exercise with Blood Flow Restriction Exercise with Blood Flow Restriction (BFR) 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).
- Primary Outcome Measures
Name Time Method Pressure pain threshold Baseline and 30 minutes 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.
- Secondary Outcome Measures
Name Time Method Pain free grip strength (PFGS) Baseline and 30 minutes '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
Trial Locations
- Locations (1)
University of West Attica
🇬🇷Aigáleo, Attiki, Greece
University of West Attica🇬🇷Aigáleo, Attiki, Greece