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Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy

Primary Purpose

Lateral Epicondylitis, Tennis Elbow, Tendonitis Elbow

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Blood flow restriction
Multimodal rehabilitation
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral elbow tendinopathy, blood flow restriction, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Between 18 and 65 years of age, Lateral tendinopathy diagnosis, Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test (PRTEE). Exclusion Criteria: Dysfunction in the shoulder, neck and/or chest area, Local or generalized arthritis. The neurological deficit. Radial dysfunction, Limitation of arm functions, A history of shoulder or upper extremity pathology requiring surgery or treatment; Venous thromboembolism Inflammation or other hematological disorders. Coronary artery disease, Peripheral arterial disease or hypertension (systolic/diastolic blood pressure >140 mm Hg/90 mmHg), To be pregnant, Irritation of median nerves. Irritation of radial nerves. Irritation of the ulnar nerves, The pain score is less than 30 mm.

Sites / Locations

  • Istanbul University - CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

8 weeks, 2 days a week, a multi-model rehabilitation program is implemented.

8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets.

Outcomes

Primary Outcome Measures

Visual Analog Scale
In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.
Painless Grip Strength
Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.
Patient-rated tennis elbow evaluation (PRTEE)
It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.

Secondary Outcome Measures

SF-12 Quality of Life Questionnaire
The SF-12 consist of 12 items assesing physical and mental health and yields 2 summary scores; the mental component summary and physical component summary. Scoring is norm based with a mean of 50; higher scores indicate better health.
Global Rating of Change
Global rating of change scale quantifies a patient's improvement or deterioration over time, and identifies the effect of an intervention or charts the clinical course of a condition. The patient selects between "much worse", "slightly worse", "stayed at same", "slightly better" and, "much better".
Range of Motion
The range of motion clarity of the shoulder, elbow, front arm and wrist joints in resting position using the gonyometer will be tested.
Manual Muscle Testing
The upper, middle and lower trapezoidal muscles, serratus anterior, biceps brachii and triceps brachii will be evaluated.
Pressure-Pain Threshold Measurement
An algometer is a device consisting of a frame displaying the pressure to be applied to this piston with a metal piston containing a round disk of about 1 cm in diameter at the end. The algometer will be asked to tell the patient the level of discomfort by pressing it at a straight angle to the most sensitive area in the lateral epicondyl area. The pressure value for the pain sensation will be determined as the pain threshold and the values obtained in kilograms (kg) will be recorded.

Full Information

First Posted
June 1, 2023
Last Updated
August 18, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT06001944
Brief Title
Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy
Official Title
Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
April 11, 2024 (Anticipated)
Study Completion Date
April 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

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

5. Study Description

Brief Summary
The investigators believe that blood flow-restricted training can result in increased caste hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that changes in local metabolic activities can be effective in the process of tendon healing. The researchers' aim in the study is to investigate the effectiveness of blood flow restriction training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50% occlusion recommended for the upper extremity using the patient's systolic pressure to the severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes period for the top extremity.
Detailed Description
Physiotherapy is the first step in the treatment algorithm for lateral elbow tendinopathy (LET), which is characterized by pain in the lateral epicondyl of the humerus during wrist extension and which limits hand-to-hand movements such as grabbing and thinning and consequently negatively affects hand functions. Extender carpi radialis brevis (ECRB) and extender digitorum, communis (EDC) are the muscles that contribute most to the onset of symptoms. Exercise, either alone or as part of a multimodal physiotherapy program, is central to the management of many patients with LDT. Exercise in patients with chronic LDT has been shown to result in more and faster relief of pain, less use of illness, less medical consultation, and increased working capacity. In literature, loading with recommended exercises is considered necessary to re-form the tendon, while on the other hand some patients may not tolerate this loading. For rehabilitation practitioners, it is quite difficult to design optimal exercise programs that facilitate musculo-skeletal system (MSK) adaptations while also enabling biological healing and safe loading of the injured body. In these cases, there has been a search for a new method that can generate physiological benefits associated with higher intensity training with exercise at lower loads. Increasing evidence supports the use of resistance training at a reduced load along with blood flow restriction (BFR) therapy to increase hypertrophic and force responses in skeletal muscle. The American Association of Sports Physicians (ACSM) recommends that at least 65% of the 1 maximum repetition, similar to exercising at high intensity with 8-12 repetition resistant weight lifting strength training, can be used in low loads such as 20% to 30% of 1 maximum repeat in the treatment to caste hypertrophy and strength. Effects of blood flow-restricted training on muscle lithium excitement, mechanical tension, metabolic stress, systemic and local hormones, vascular endothelial growth factor (VEGF) and oxidative stress mechanisms have been. There have been no randomized controlled studies in the literature on the effectiveness of BFR training in tendinopathies. However, case studies and series of cases have been included and no contraindications of BFR have been for patients with tendinopathy. The increasing number of studies on various diseases in the literature is a proof of this.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tennis Elbow, Tendonitis Elbow
Keywords
lateral elbow tendinopathy, blood flow restriction, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.
Allocation
Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
8 weeks, 2 days a week, a multi-model rehabilitation program is implemented.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets.
Intervention Type
Other
Intervention Name(s)
Blood flow restriction
Intervention Description
The BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength.
Intervention Type
Other
Intervention Name(s)
Multimodal rehabilitation
Intervention Description
Patients with LDT will be informed that the condition will be gradually resolved with adequate rest and time. Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Title
Painless Grip Strength
Description
Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Title
Patient-rated tennis elbow evaluation (PRTEE)
Description
It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Secondary Outcome Measure Information:
Title
SF-12 Quality of Life Questionnaire
Description
The SF-12 consist of 12 items assesing physical and mental health and yields 2 summary scores; the mental component summary and physical component summary. Scoring is norm based with a mean of 50; higher scores indicate better health.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Title
Global Rating of Change
Description
Global rating of change scale quantifies a patient's improvement or deterioration over time, and identifies the effect of an intervention or charts the clinical course of a condition. The patient selects between "much worse", "slightly worse", "stayed at same", "slightly better" and, "much better".
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Title
Range of Motion
Description
The range of motion clarity of the shoulder, elbow, front arm and wrist joints in resting position using the gonyometer will be tested.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Title
Manual Muscle Testing
Description
The upper, middle and lower trapezoidal muscles, serratus anterior, biceps brachii and triceps brachii will be evaluated.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up
Title
Pressure-Pain Threshold Measurement
Description
An algometer is a device consisting of a frame displaying the pressure to be applied to this piston with a metal piston containing a round disk of about 1 cm in diameter at the end. The algometer will be asked to tell the patient the level of discomfort by pressing it at a straight angle to the most sensitive area in the lateral epicondyl area. The pressure value for the pain sensation will be determined as the pain threshold and the values obtained in kilograms (kg) will be recorded.
Time Frame
Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 18 and 65 years of age, Lateral tendinopathy diagnosis, Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test (PRTEE). Exclusion Criteria: Dysfunction in the shoulder, neck and/or chest area, Local or generalized arthritis. The neurological deficit. Radial dysfunction, Limitation of arm functions, A history of shoulder or upper extremity pathology requiring surgery or treatment; Venous thromboembolism Inflammation or other hematological disorders. Coronary artery disease, Peripheral arterial disease or hypertension (systolic/diastolic blood pressure >140 mm Hg/90 mmHg), To be pregnant, Irritation of median nerves. Irritation of radial nerves. Irritation of the ulnar nerves, The pain score is less than 30 mm.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fulya DEMIRHAN, PHd Student
Phone
+90-532-353-2208
Email
f.gurcenan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yıldız ANALAY AKBABA, Assoc.prof.
Phone
+90-532-377-4013
Email
yildizanalay@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yıldız ANALAY AKBABA, Assoc. prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University - Cerrahpasa
City
Istanbul
State/Province
Büyükçekmece
ZIP/Postal Code
No:5/9/1
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fulya DEMIRHAN, PHd Student
Phone
+90-532-353-2208
Email
f.gurcenan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33002980
Citation
Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440.
Results Reference
background
PubMed Identifier
31543413
Citation
Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.
Results Reference
background
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
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
background
PubMed Identifier
36914496
Citation
Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Mar 11:S0894-1130(22)00113-2. doi: 10.1016/j.jht.2022.11.005. Online ahead of print.
Results Reference
background

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Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy

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