Blood Flow Restriction Training in Patients With Shoulder Pain

February 12, 2022 updated by: Dilara Kara, Hacettepe University

The Effect of Blood Flow Restriction Training on Muscle Thickness and Symptoms in Patients With Rotator Cuff Tendinopathy

This study was planned to investigate the effect of blood flow restriction exercise training on shoulder muscle strength and muscle thickness, and to determine the change in pain and symptoms in patients with rotator cuff tendinopathy. Patients in the study group will perform the rehabilitation exercises with a pneumatic cuff and blood flow restricted. The patients in the control group will perform the same exercise program without restricting blood flow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent years, one of the popular applications used for muscle hypertrophy and strength training is low-intensity exercise training called Blood Flow Restriction Training. This exercise training has been shown to allow the benefits of high-intensity training at a much lower intensity. Given the light-load nature and strengthening capacity of this training, it can provide an effective clinical rehabilitation stimulus without the high levels of joint stress. It is suggested that it will be a useful exercise alternative especially in individuals who cannot tolerate high-intensity exercise. Especially patients with shoulder pain cannot tolerate high-intensity exercises in early rehabilitation.

This study was planned to investigate the effect of blood flow restriction exercise training on shoulder muscle strength and muscle thickness, and to determine the change in pain and symptoms in patients with rotator cuff tendinopathy.

Hypothesis 1: There is a difference between exercise training with blood flow restriction and exercise training without blood flow restriction in terms of muscle strength and muscle thickness.

Hypothesis 2: There is a difference between exercise training with blood flow restriction and exercise training without blood flow restriction in terms of shoulder pain and shoulder function.

The study was designed as a randomized-controlled. In order to provide an evenly equal number of individuals and homogeneous gender distribution in the groups blocking and stratification will be used as a randomization method. The sample size was calculated to be an 8% difference in muscle thickness at the end of treatment with 80% power and 5% type 1 error. A total of 26 patients were planned to be included in the study, including 13 volunteers in each group. Patients in the study group will perform the determined exercises with a pneumatic cuff and blood flow restricted. The patients in the control group will perform the same exercise program without restricting blood flow. Informed consent will be obtained from all individuals.

Demographic information (age, gender, body mass index, dominant side, affected side, etc.) of all patients will be recorded. Shoulder pain (rest, night and activity- visual analog scale), shoulder range of motions (goniometer), shoulder function (Shoulder Pain and Disability Index-SPADI), shoulder rotator muscle strength (isokinetic dynamometer-Isomed 2000, D&R Ferstl GmbH, Germany) and supraspinatus, infraspinatus, deltoid, biceps, middle trapezius muscle thickness, and acromio-humeral distance (ultrasonography- Logiq P5, General Electrics, USA) will be evaluated before and after 8 weeks of exercise training.

In the first session of treatment, initial assessments and patient education to reduce shoulder pain (avoiding overhead activities and heavy work, appropriate posture, cold-pack application recommendation) will be performed. Exercise training will start in the second session. Individuals in the groups will have 2 sessions per week, 16 sessions of exercise training for 8 weeks. On other days, patients will continue their home exercises recommended by the physiotherapist.

The blood flow restriction training will be applied to patients in the study group, as defined in the literature, by wearing a pneumatic cuff from the most proximal region of the upper limb. Occlusion pressure will be calculated according to the formula for each patient. [Pressure = 0.4 x (systolic blood pressure) + 2.7 x (shoulder circumference) + 62]. Blood flow restriction training will be performed at 30-40% of the arterial occlusion pressure for the upper limb and total duration of 15 minutes. The amount of occlusion pressure will be re-evaluated every two weeks.

Statistical analyses will perform using SPSS program. Descriptive statistics will be presented with means and standard deviations for numerical data and with numbers (n) and percentages (%) for non-numerical data. The suitability of the data obtained from the patients to the normal distribution will be evaluated by the Kolmogorov-Smirnov test. In the case of the normal distribution of data, comparisons between groups will be tested using repeated-measures analysis of variance (two-way ANOVA). When the parametric test conditions are not met, before-after differences within the group will be calculated and the Mann Whitney U test will be used in the analysis of the differences between the groups. Wilcoxon test will be used in intra-group comparisons before and after treatment. In all analyzes, the significance value will be determined as p=0.05.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University
      • Ankara, Turkey, 06230
        • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with rotator cuff related shoulder pain (tendinopathy findings in ultrasonographic evaluation).

Description

Inclusion Criteria:

  • Volunteer to participate in the study
  • Being 18-45 years
  • Unilateral rotator cuff related shoulder pain
  • No symptoms in the contralateral shoulder

Exclusion Criteria:

  • Diagnosis of hypertension, cardiovascular diseases, peripheral vascular diseases, deep vein thrombosis history, neurological diseases, systemic inflammation, obesity, diabetes
  • Subject has cancer
  • Pregnancy status
  • Cervical symptoms
  • Shoulder range of motion limitation
  • Injection to the shoulder joint in the last 6 months
  • Individuals who do not agree to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exercise with BFR
Patients with rotator cuff tendinopathy will perform the exercises with a pneumatic cuff and blood flow restricted.
Other: Exercise training
Exercise with blood flow restriction (with a pneumatic cuff).
Other Names:
  • Blood flow restriction training
Control
Patients with rotator cuff tendinopathy will perform the exercises without a pneumatic cuff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in shoulder muscle thickness and acromio-humeral distance
Time Frame: baseline and 8 weeks
Ultrasonography measurement: supraspinatus, infraspinatus, deltoid, biceps, middle trapezius muscle thickness and acromio-humeral distance.
baseline and 8 weeks
Changes in shoulder muscle strength
Time Frame: baseline and 8 weeks
Isokinetic assesment: shoulder rotator muscle concentric strength at 60 º/sec and 180 º/sec speeds.
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in shoulder pain: visual analogue scale
Time Frame: baseline and 8 weeks
Self reported pain at rest, activity and night with 10cm visual analogue scale. 0=no pain, 10=pain as bad as can be.
baseline and 8 weeks
Changes in shoulder function
Time Frame: baseline and 8 weeks
Shoulder pain and disability index. It consist of two subscales (pain and disability) are averaged to produce a total score ranging from 0 (best) to 100 (worst).
baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Levent Ozcakar, PhD,Prof., Hacettepe University
  • Principal Investigator: Irem Duzgun, PhD,Prof., Hacettepe University
  • Principal Investigator: Dilara Kara, MSc., Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

January 21, 2022

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 12, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/02-28 (KA-19146)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Tendinosis

Clinical Trials on Exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe