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

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ClinicalTrials.gov Identifier: NCT04154592
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Caner Karartı, Hacettepe University

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Surgery Other: Humeral Head Depressor Muscle Co-Activation Training- Experimental Group Other: Control Group Not Applicable

Detailed Description:
Shoulder pain is one of the most common types of musculoskeletal pain syndroms in the general population as its prevalence has been estimated between 7% and 26% and its annual incidence between 0.9% and 2.5%. Rotator cuff tear is one of the most common causes of painful shoulders. Lack of coordination or weakness of scapulothoracic and scapulohumeral muscles is one of the main factors thought to lead to muscle tears in shoulder. More specifically, the inability of the scapular muscles to achieve superior rotation and posterior tilt, as well as the failure of rotator cuff muscles to counter the superior humeral head translation imposed by deltoid contraction can lead to impingement of the subacromial soft tissues while performing overhead dynamic tasks. This increases the rotator cuff tears' prevalance. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Single (Care Provider)
Masking Description: Single blinded
Primary Purpose: Treatment
Official Title: The Effect of Humeral Head Depressor Muscle Co-Activation Training on Functional Outcomes in Patients Undergoing Arthroscopic Shoulder Surgery After Middle-Size Rotator Cuff Muscle Tear
Estimated Study Start Date : December 20, 2019
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Experimental Group
In addition to the conservative treatment of the control group, humeral head depressor muscle co-activation training will be applied for 8 weeks.
Other: Humeral Head Depressor Muscle Co-Activation Training- Experimental Group
In addition to the conservative treatment, humeral head depressor muscle co-activation training will be applied for 8 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.

Active Comparator: Control Group
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

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 14 weeks (a total of 8 weeks) will be admitted to the rehabilitation program according to the guideline mentioned above.





Primary Outcome Measures :
  1. Visual Analogue Scale (Pain) [ Time Frame: 8 weeks ]
    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%.


Secondary Outcome Measures :
  1. The Constant-Murley Score [ Time Frame: 8 weeks ]
    The Constant-Murley Score is the most widely used shoulder evaluating instrument in Europe despite its limitations. The 100-point scoring scale takes into account both subjective and objective measurements and is divided into four domains (pain: 15 points; activities of daily living: 20 points; range of motion: 40 points; strength: 25 points). Minimal clinically important difference (MCID) for Constant-Murley Score is reported to be between 10.4 and 17 points.

  2. Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 8 weeks ]
    WORC is a disease specific self-reported instrument for rotator cuff disease. It consists 21 visual analogue scale (VAS) items in five domains: physical symptoms (six items), sports/recreation (four items), work (four items), lifestyle (four items) and emotions (three items). All items respect quality of life (QoL) aspects that can particularly be influenced by rotator cuff injury. Each item has a possible score from 0 to 100 (100 mm VAS), and these scores are added to give a total score from 0 to 2100. A score of 0 implies no reduction in QoL, and a score of 2100 is the worst score possible. The data can be converted to a percent score by inverting the raw score and then converting it to a score out of 100 (2100 'patient WORC raw score'/21). The domains are based on the WHO definition of health. WORC is determined to have the highest ratings among all shoulder instruments. The minimally clinically important change (MCIC) for WORC is reported to be 275 points or 12.8%.

  3. DASH Score [ Time Frame: 8 weeks ]
    The DASH questionnaire is a 30-item questionnaire that assesses upper extremity-related symptoms and measures functional status at the level of disability. The questionnaire consists of three sections: Symptoms; Sport and Music; and Work. The first section is composed of 30 items. The second and third sections are an optional module for Sport and Music, and four items for Work. Each item is scored with a 5-point scale: 1, no difficulty/symptoms; 2, mild difficulty/symptoms; 3, moderate difficulty/symptoms; 4, severe difficulty/symptoms; 5, extreme difficulty/symptoms (unable to do). The result of each module is summed and transformed to obtain the DASH score ranging, for each section, from 0 (best function) to 100 (severe disability).

  4. Oxford Shoulder Score [ Time Frame: 8 weeks ]
    Oxford Shoulder Score (OSS), a 12-item scale rated on a five-point Likert scale from 0-4 (0=poor function, 4=good function). Daily pain and number of repetitions per exercise during home exercises were rated in the participants' diary.

  5. Range of Motion [ Time Frame: 8 weeks ]
    A universal goniometer will be used for measuring of range of motion (flexion, extension, elevation, abduction, external rotation, and internal rotation).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154592


Contacts
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Contact: Caner KARARTI, PT, MSc. +903862805362 fzt.caner.92@gmail.com
Contact: Hakkı Çağdaş BASAT, Assoc. Prof. +905057721489 cagdasbasat@gmail.com

Sponsors and Collaborators
Hacettepe University
Publications:
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Responsible Party: Caner Karartı, Caner Karartı, Hacettepe University, Hacettepe University
ClinicalTrials.gov Identifier: NCT04154592    
Other Study ID Numbers: 2019500
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caner Karartı, Hacettepe University:
rotator cuff
tear
rehabilitation
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries