Blood Flow Restriction Training in Patients With Shoulder Pain

Rotator Cuff Tendinosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333784
• Other study ID #: 2020/02-28 (KA-19146)
• Status: Completed
• Start date: December 21, 2020
• Est. completion date: January 21, 2022

Study information

• Verified date: February 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 21, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Shoulder Pain
• Tendinopathy

Intervention

Other:
• Exercise training
Exercise with blood flow restriction (with a pneumatic cuff).

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

Benitez-Martinez JC, Casaña-Granell J, de Llago YE, Villaron-Casales C, Espi-Lopez GV, Jimenez-Diaz F. Cross Sectional Area of the Supraspinatus Muscle and Acromio-humeral Distance in Overhead Athletes With and Without Shoulder Pain: A Cross-sectional Study. J Sport Rehabil. 2017 Nov;26(6):524-529. doi: 10.1123/jsr.2016-0146. Epub 2016 Nov 11. — View Citation

Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities: A Randomized Controlled Trial. Sports Health. 2019 Mar/Apr;11(2):149-156. doi: 10.1177/1941738118821929. Epub 2019 Jan 14. — View Citation

Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7. Review. — View Citation

Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4. Review. — View Citation

Ladlow P, Coppack RJ, Dharm-Datta S, Conway D, Sellon E, Patterson SD, Bennett AN. Low-Load Resistance Training With Blood Flow Restriction Improves Clinical Outcomes in Musculoskeletal Rehabilitation: A Single-Blind Randomized Controlled Trial. Front Physiol. 2018 Sep 10;9:1269. doi: 10.3389/fphys.2018.01269. eCollection 2018. — View Citation

Land H, Gordon S, Watt K. Isokinetic clinical assessment of rotator cuff strength in subacromial shoulder impingement. Musculoskelet Sci Pract. 2017 Feb;27:32-39. doi: 10.1016/j.msksp.2016.11.012. Epub 2016 Dec 10. — View Citation

Lewis J. Rotator cuff related shoulder pain: Assessment, management and uncertainties. Man Ther. 2016 Jun;23:57-68. doi: 10.1016/j.math.2016.03.009. Epub 2016 Mar 26. — View Citation

Littlewood C, Malliaras P, Chance-Larsen K. Therapeutic exercise for rotator cuff tendinopathy: a systematic review of contextual factors and prescription parameters. Int J Rehabil Res. 2015 Jun;38(2):95-106. doi: 10.1097/MRR.0000000000000113. Review. — View Citation

Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Exercise with blood flow restriction: an updated evidence-based approach for enhanced muscular development. Sports Med. 2015 Mar;45(3):313-25. doi: 10.1007/s40279-014-0288-1. Review. — View Citation

Seitz AL, Podlecki LA, Melton ER, Uhl TL. NEUROMUSCULAR ADAPTIONS FOLLOWING A DAILY STRENGTHENING EXERCISE IN INDIVIDUALS WITH ROTATOR CUFF RELATED SHOULDER PAIN: A PILOT CASE-CONTROL STUDY. Int J Sports Phys Ther. 2019 Feb;14(1):74-87. — View Citation

Thiebaud RS, Loenneke JP, Fahs CA, Rossow LM, Kim D, Abe T, Anderson MA, Young KC, Bemben DA, Bemben MG. The effects of elastic band resistance training combined with blood flow restriction on strength, total bone-free lean body mass and muscle thickness in postmenopausal women. Clin Physiol Funct Imaging. 2013 Sep;33(5):344-52. doi: 10.1111/cpf.12033. Epub 2013 Apr 3. — View Citation

Van Roekel HE, Thurston AJ. Tourniquet pressure: the effect of limb circumference and systolic blood pressure. J Hand Surg Br. 1985 Jun;10(2):142-4. — View Citation

Yasuda T, Fujita S, Ogasawara R, Sato Y, Abe T. Effects of low-intensity bench press training with restricted arm muscle blood flow on chest muscle hypertrophy: a pilot study. Clin Physiol Funct Imaging. 2010 Sep;30(5):338-343. doi: 10.1111/j.1475-097X.2010.00949.x. Epub 2010 Jul 4. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in shoulder muscle thickness and acromio-humeral distance	Ultrasonography measurement: supraspinatus, infraspinatus, deltoid, biceps, middle trapezius muscle thickness and acromio-humeral distance.	baseline and 8 weeks
Primary	Changes in shoulder muscle strength	Isokinetic assesment: shoulder rotator muscle concentric strength at 60 º/sec and 180 º/sec speeds.	baseline and 8 weeks
Secondary	Changes in shoulder pain: visual analogue scale	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
Secondary	Changes in shoulder function	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