The Effect of Humeral Head Depressor Muscle Co-Activation Training in Terms of Functional Outcomes

NCT04154592 | Completed

• 1 other identifier: 2019500
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Recent systematic reviews, and meta-analyses concluded that rotator cuff and scapular strengthening exercises should be included in rehabilitation programs for patients with middle-size rotator cuff muscle tear. Superior translation of the humeral head is one of the factors adversely affecting this rehabilitation process. Aside from rotator cuff muscles, opposition of superior humeral head translation can be achieved by the glenohumeral adductors (i.e. pectoralis major, latissimus dorsi muscles, and teres major), which act as humeral head depressors by means of the medio-inferior vector created by the orientation of their tendons. Recruitment of the glenohumeral adductors has been shown to decrease subacromial narrowing in elevated arms in asymptomatic individuals, and is thought to be a coping mechanism to decrease pain in individuals with rotator cuff tear. However, to the best of our knowledge, the efficacy of humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear has never been evaluated in patients with middle-size rotator cuff muscle tear. Since recruitment of those muscles could prevent a decrease in subacromial space during arm elevation, it could potentially lead to improved exercise performance, earlier benefits and better treatment outcomes compared to routine rotator cuff strengthening exercises. Thus, the aim of this study was to investigate the efficacy of the humeral head depressor muscle co-activation training on functional outcomes in patients undergoing arthroscopic shoulder surgery after middle-size rotator cuff muscle tear.

Conditions

Rotator Cuff Tears; Surgery

Keywords

rotator cuff; tear; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (Pain)

  The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. The 11-point numeric scale ranges from '0' representing no pain to '10' representing pain as bad as you can imagine or worst pain imaginable. We use VAS to measure patient's perceived pain intensity during activity, at rest and at sleep during the last week preceding the assessment. MCIC for pain VAS is reported to be 2 points or 30%.

  14 weeks

Secondary Outcomes (5)

• The Constant-Murley Score

  14 weeks

• Western Ontario Rotator Cuff Index (WORC)

  14 weeks

• DASH Score

  14 weeks

• Oxford Shoulder Score

  14 weeks

• Range of Motion

  14 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

In addition to the conservative treatment of the control group, humeral head depressor muscle co-activation training will be applied for 14 weeks.

Other: Humeral Head Depressor Muscle Co-Activation Training- Experimental Group

Control Group

ACTIVE COMPARATOR

The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., \& Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.).

Other: Control Group

Interventions

Humeral Head Depressor Muscle Co-Activation Training- Experimental Group OTHER

In addition to the conservative treatment, humeral head depressor muscle co-activation training will be applied for 14 weeks. Participants in the coactivation group will perform the glenohumeral exercises while recruiting the pectoralis major, latissimus dorsi, and teres major muscles. To achieve this, voluntary recruitment of the pectoralis major, latissimus dorsi, and teres major will be taught prior to the demonstration of the glenohumeral exercises using visual feedback provided by EMG Biofeedback. When recruitment is correctly executed (50% of the maximum voluntary contraction signal), it should be maintained while performing the glenohumeral exercises. This will be confirmed by visualizing EMG signals during the exercise training session. During each appointment with the therapist, participants will be evaluated on their capacity to achieve the exercises while performing co-activation.

Experimental Group

Control Group OTHER

The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., \& Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.). Individuals in the control group will use shoulder straps for 6 weeks after arthroscopic shoulder surgery. These patients will be referred to physiotherapy clinics 6th week. Patients between 6 and 20 weeks (a total of 14 weeks) will be admitted to the rehabilitation program according to the guideline mentioned above.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• the presence of middle-sized (1-3 cm) rotator cuff muscle rupture,
• undergoing arthroscopic repair surgery,
• volunteering to participate in the study.

You may not qualify if:

• presence of diabetic mellitus,
• stage 3 and above according to Goutallier classification,
• presence of any contraindication for mobilization (hypermobility, trauma, inflammation, etc.),
• visual, verbal, cognitive defects (aphasia, unilateral neglect, etc.),
• the presence of any neurological problem,
• the presence of cervical disc hernia.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (3)

• Ryosa A, Kukkonen J, Bjornsson Hallgren HC, Moosmayer S, Holmgren T, Ranebo M, Boe B, Aarimaa V; ACCURATE study group. Acute Cuff Tear Repair Trial (ACCURATE): protocol for a multicentre, randomised, placebo-controlled trial on the efficacy of arthroscopic rotator cuff repair. BMJ Open. 2019 May 19;9(5):e025022. doi: 10.1136/bmjopen-2018-025022.

  PMID: 31110087 BACKGROUND

• Boudreau N, Gaudreault N, Roy JS, Bedard S, Balg F. The Addition of Glenohumeral Adductor Coactivation to a Rotator Cuff Exercise Program for Rotator Cuff Tendinopathy: A Single-Blind Randomized Controlled Trial. J Orthop Sports Phys Ther. 2019 Mar;49(3):126-135. doi: 10.2519/jospt.2019.8240. Epub 2018 Nov 30.

  PMID: 30501388 BACKGROUND

• Overbeek CL, Kolk A, Nagels J, de Witte PB, van der Zwaal P, Visser CPJ, Fiocco M, Nelissen RGHH, de Groot JH. Increased co-contraction of arm adductors is associated with a favorable course in subacromial pain syndrome. J Shoulder Elbow Surg. 2018 Nov;27(11):1925-1931. doi: 10.1016/j.jse.2018.06.015. Epub 2018 Sep 19.

  PMID: 30243903 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Lacerations

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Caner Karartı, Hacettepe University

Model Details: Randomized

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 6, 2019
• Study Start: July 7, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 20, 2021
• Last Updated: February 4, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)