Blood Flow Restriction Training in Patients With Shoulder Pain

NCT04333784 | Completed DMC

• 1 other identifier: 2020/02-28 (KA-19146)
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rotator Cuff Tendinosis

Keywords

blood flow restriction training; shoulder pain; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Changes in shoulder pain: visual analogue scale

  baseline and 8 weeks

• Changes in shoulder function

  baseline and 8 weeks

Study Arms (2)

exercise with BFR

Patients with rotator cuff tendinopathy will perform the exercises with a pneumatic cuff and blood flow restricted.

Other: Exercise training

Control

Patients with rotator cuff tendinopathy will perform the exercises without a pneumatic cuff.

Interventions

Exercise training OTHER

Exercise with blood flow restriction (with a pneumatic cuff).

Also known as: Blood flow restriction training

exercise with BFR

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06230, Turkey (Türkiye)

Location

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 27083390 BACKGROUND

• Benitez-Martinez JC, Casana-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.

  PMID: 27834581 BACKGROUND

• 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.

  PMID: 25715230 BACKGROUND

• 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.

  PMID: 30746294 BACKGROUND

• 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.

  PMID: 26446893 BACKGROUND

• 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.

  PMID: 28259850 BACKGROUND

• 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.

  PMID: 30246795 BACKGROUND

• 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.

  PMID: 25430600 BACKGROUND

• 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.

  PMID: 23701116 BACKGROUND

• 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.

  PMID: 30638439 BACKGROUND

• 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.

  PMID: 20618358 BACKGROUND

• 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. doi: 10.1016/0266-7681(85)90002-6.

  PMID: 4031590 BACKGROUND

• 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.

  PMID: 28637599 BACKGROUND

• Kara D, Ozcakar L, Demirci S, Huri G, Duzgun I. Blood Flow Restriction Training in Patients With Rotator Cuff Tendinopathy: A Randomized, Assessor-Blinded, Controlled Trial. Clin J Sport Med. 2024 Jan 1;34(1):10-16. doi: 10.1097/JSM.0000000000001191. Epub 2023 Sep 14.

  PMID: 37706671 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain

Interventions

Exercise; Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Levent Ozcakar, PhD,Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Irem Duzgun, PhD,Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Dilara Kara, MSc.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate, Research assistant

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: December 21, 2020
• Primary Completion: December 20, 2021
• Study Completion: January 21, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

TU (2)