Clinical trial NCT05919914: The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.
Official title: The Immediate Effects of a Wrist Extensors Exercise With Blood Flow Restriction BFR in Lateral Elbow Tendinopathy. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: tennis elbow
pain threshold
elbow tendinopathy
BFR
hypoalgesia
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pressure pain threshold
timeFrame: Baseline and 30 minutes
Secondary outcomes:
measure: Pain free grip strength (PFGS)
timeFrame: Baseline and 30 minutes
Other outcomes:
Locations:
city: Aigáleo
country: Greece
facility: University of West Attica
state: Attiki
city: Aigáleo
country: Greece
facility: University of West Attica
state: Attiki
Study officials:
affiliation: Physiotherapy Department
name: George Gioftsos, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
citation: Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid. 2011 Jun 27;2011:1117.
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.
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.