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

Primary Purpose

Lateral Epicondylitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Exercise with Blood Flow Restriction (BFR)
Exercise without Blood Flow Restriction (BFR)
Sponsored by
University of West Attica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring tennis elbow, pain threshold, elbow tendinopathy, BFR, hypoalgesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of West Attica
  • University of West Attica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wrist extensor exercise with Blood Flow Restriction

Wrist extensor exercise without Blood Flow Restriction

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2023
Last Updated
July 6, 2023
Sponsor
University of West Attica
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1. Study Identification

Unique Protocol Identification Number
NCT05919914
Brief Title
The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.
Acronym
BFR
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 29, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of West Attica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
tennis elbow, pain threshold, elbow tendinopathy, BFR, hypoalgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wrist extensor exercise with Blood Flow Restriction
Arm Type
Experimental
Arm 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).
Arm Title
Wrist extensor exercise without Blood Flow Restriction
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Exercise with Blood Flow Restriction (BFR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise without Blood Flow Restriction (BFR)
Intervention Description
Wrist extensor exercise (concentric - eccentric)
Primary Outcome Measure Information:
Title
Pressure pain threshold
Description
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.
Time Frame
Baseline and 30 minutes
Secondary Outcome Measure Information:
Title
Pain free grip strength (PFGS)
Description
'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
Time Frame
Baseline and 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Gioftsos, PhD
Organizational Affiliation
Physiotherapy Department
Official's Role
Study Chair
Facility Information:
Facility Name
University of West Attica
City
Aigáleo
State/Province
Attiki
ZIP/Postal Code
12243
Country
Greece
Facility Name
University of West Attica
City
Aigáleo
State/Province
Attiki
ZIP/Postal Code
15271
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36099170
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.
Results Reference
background
PubMed Identifier
36999107
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.
Results Reference
background
PubMed Identifier
24634444
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.
Results Reference
background
PubMed Identifier
34501416
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.
Results Reference
background
PubMed Identifier
21708051
Citation
Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid. 2011 Jun 27;2011:1117.
Results Reference
background
PubMed Identifier
29706713
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.
Results Reference
background
PubMed Identifier
26381484
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.
Results Reference
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The Effects of a Wrist Extensors Exercise With Blood Flow Restriction (BFR) in Lateral Elbow Tendinopathy.

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