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

Lateral Epicondylitis Clinical Trial

— BFR  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05919914
• Other study ID #: 11168 - 06/02/2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 29, 2023
• Est. completion date: May 2024

Study information

• Verified date: July 2023
• Source: University of West Attica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Elbow Tendinopathy
• Lateral Epicondylitis
• Tendinopathy
• Tennis Elbow

Intervention

Other:
• 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.
• Exercise without Blood Flow Restriction (BFR)
Wrist extensor exercise (concentric - eccentric)

Locations

Country	Name	City	State
Greece	University of West Attica	Aigáleo	Attiki
Greece	University of West Attica	Aigáleo	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of West Attica

Country where clinical trial is conducted

Greece, 

References & Publications (7)

Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid. 2011 Jun 27;2011:1117. — View Citation

Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17. — View Citation

Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13. — View Citation

Karanasios S, Lignos I, Gioftsos G. Wrist Extensor Training With Blood Flow Restriction for the Management of Lateral Elbow Tendinopathy: A Case Report. Cureus. 2023 Feb 25;15(2):e35468. doi: 10.7759/cureus.35468. eCollection 2023 Feb. — View Citation

Lee JH, Kim TH, Lim KB. Effects of eccentric control exercise for wrist extensor and shoulder stabilization exercise on the pain and functions of tennis elbow. J Phys Ther Sci. 2018 Apr;30(4):590-594. doi: 10.1589/jpts.30.590. Epub 2018 Apr 20. — View Citation

Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of eccentric vs. concentric graded exercise in chronic tennis elbow (lateral elbow tendinopathy). Clin Rehabil. 2014 Sep;28(9):862-72. doi: 10.1177/0269215514527595. Epub 2014 Mar 14. — View Citation

Yoon SY, Kim YW, Shin IS, Kang S, Moon HI, Lee SC. The Beneficial Effects of Eccentric Exercise in the Management of Lateral Elbow Tendinopathy: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 1;10(17):3968. doi: 10.3390/jcm10173968. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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