Kırşehir Ahi Evran University
Kırşehir, 40100, Turkey (Türkiye)
Location status: Recruiting
Recruiting
NCT Number: NCT07309796
Strengthening Exercises for Humeral Head Depressor Muscles
Postoperative rehabilitation after reverse shoulder arthroplasty aims to improve pain control, range of motion, and functional capacity. However, studies examining the effects of strengthening exercises targeting the humeral head depressor muscles are limited. This randomized controlled trial will evaluate the effects of adding a specific strengthening program to standard rehabilitation on pain, range of motion, quality of life, and functional outcomes.
Recruiting
Interested in participating?
Request InfoKey information
Age range
65 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Reverse shoulder arthroplasty (RSA) is an effective surgical method, particularly in cases of massive rotator cuff tears that lead to irreversible loss of shoulder function. The primary goals of postoperative rehabilitation are to reduce pain, improve shoulder joint functions, optimize scapulothoracic rhythm, and safely restore functional use. However, studies examining the effects of specific strengthening exercises targeting the humeral head depressor muscle group (latissimus dorsi, teres major, infraspinatus, etc.) on clinical outcomes are quite limited. This study aims to evaluate the effects of a specific strengthening protocol designed for the humeral head depressor muscles following reverse shoulder arthroplasty on pain, range of motion (ROM), quality of life, functional status, and psychological well-being. Planned as a randomized controlled trial, the research will apply an additional humeral head depressor muscle strengthening program to the standard conventional rehabilitation protocol in the experimental group, while the control group will receive only the standard rehabilitation program.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients scheduled for primary reverse total shoulder arthroplasty Intact teres minor confirmed by physical examination (Hornblower's test) and intraoperative assessment Ability to participate in physiotherapy or a home exercise program
Exclusion criteria
- Active infection Deltoid muscle insufficiency Inability or unwillingness to comply with randomization Prior shoulder arthroplasty on the same side Unwillingness to participate Inability to read or understand written instructions
Treatment and study plan
Conventional Rehabilitation Group
OtherAfter randomization and baseline assessments, participants will undergo a standard 6-week postoperative shoulder rehabilitation program, consisting of range-of-motion exercises, scapular stabilization training, and progressive strengthening. No additional depressor muscle-specific exercises will be applied.
Depressor Muscle Strengthening Group
OtherAfter randomization and baseline assessments, participants will receive a 6-week rehabilitation program consisting of conventional postoperative shoulder rehabilitation combined with a specific strengthening protocol targeting the shoulder depressor muscles.
Primary outcomes
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Pain Intensity (Visual Analog Scale - VAS)
Time frame: 6 weeks
Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from "no pain" to "worst imaginable pain." The distance from the "no pain" anchor to the participant's mark will be measured in millimeters (0-100 mm), with higher scores indicating higher pain intensity.
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Upper Extremity Disability (Disabilities of the Arm, Shoulder and Hand Questionnaire - DASH)
Time frame: 6 weeks
The DASH is a 30-item self-administered questionnaire assessing upper-extremity functional limitations. Items are scored 1-5 and converted to a 0-100 scale, where higher scores indicate greater disability.
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Shoulder Range of Motion (ROM)
Time frame: 6 weeks
Active shoulder flexion, abduction, external rotation, and internal rotation will be measured using a standard goniometer. Results will be recorded in degrees (°).
Secondary outcomes
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Shoulder Function (American Shoulder and Elbow Surgeons Score - ASES)
Time frame: 6 weeks
The ASES score includes pain and functional assessments, yielding a total score between 0 and 100. Higher scores represent better shoulder function.
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Thoracic Kyphosis Angle (Spinal Mouse Assessment)
Time frame: 6 weeks
Thoracic spine curvature will be evaluated using the Spinal Mouse device during flexion and extension. The system provides non-invasive, objective measurements of thoracic kyphosis.
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Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Time frame: 6 weeks
The PCS consists of 13 items assessing rumination, magnification, and helplessness. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
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Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
Time frame: 6 weeks
HADS includes 14 items (7 anxiety, 7 depression), each scored 0-3. Higher scores indicate higher levels of anxiety or depression.
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Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Time frame: 6 weeks
The TSK is a 17-item tool measuring fear of movement and reinjury. Scores range between 17 and 68, with higher scores indicating greater kinesiophobia.
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Quality of Life (12-Item Short-Form Health Survey - SF-12)
Time frame: 6 weeks
The SF-12 generates Physical Component Summary (PCS) and Mental Component Summary (MCS) scores ranging from 0 to 100. Higher scores reflect better health-related quality of life.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Hacettepe University
Other
Registry information
Official study title
The Effect of Strengthening Exercises for Humeral Head Depressor Muscles on Clinical Outcomes After Reverse Shoulder Arthroplasty
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 30, 2025
- Registry last updated
- Mar 3, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.