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

Not Applicable
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Wrist extensor exercise without Blood Flow RestrictionExercise 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 RestrictionExercise 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
NameTimeMethod
Pressure pain thresholdBaseline 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
NameTimeMethod
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

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