- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07228936
The Role of Pectoralis Minor Tightness in the Development of Rotator Cuff Tears (PMinor-Rotator)
The Role of Pectoralis Minor Muscle Tightness in the Development of Rotator Cuff Tears: A Propensity Score Matched Case-Control Study
This study investigates whether tightness of a small chest muscle called the pectoralis minor is associated with the development of rotator cuff tears in the shoulder. Using a propensity score matched case-control design, the study compares patients with rotator cuff tears (case group, n=45) to patients with intact rotator cuffs (control group, n=45).
Adults aged 18-55 with shoulder pain who are evaluated by MRI and/or shoulder arthroscopy at Gazi University Hospital may be invited. The case group includes patients found to have rotator cuff tears during arthroscopy. The control group includes patients whose rotator cuff was documented as intact by MRI and/or arthroscopy (e.g., patients treated for labral, SLAP, or instability pathology). Groups are matched 1:1 on age, sex, BMI, occupation, sportive activity and dominant side.
Before surgery, a trained clinician measures shoulder posture and pectoralis minor length using simple external tools (a digital caliper and ruler-like square). For arthroscopy patients, the surgeon records general arthroscopic findings. No extra procedures are added for research.
We expect to include 90 participants total. The primary hypothesis is that pectoralis minor tightness is more prevalent in patients with rotator cuff tears compared to controls. A secondary hypothesis is that tears in patients with pectoralis minor tightness more often begin on the bursal side. Results may help clinicians understand shoulder mechanics and improve prevention or rehabilitation strategies.
Study Overview
Status
Detailed Description
Rationale and Objectives Pectoralis minor (PM) tightness alters scapular position (anterior tilt, internal rotation) and may increase subacromial compression. This propensity score matched case-control study evaluates whether PM tightness is associated with the development of rotator cuff tears (RCTs) and, secondarily, whether tears in PM-tight shoulders more often begin on the bursal side.
Design and Setting Single-center, propensity score matched case-control study at a tertiary academic hospital (orthopaedic shoulder service, Gazi University Hospital). Care is not altered by participation. All surgical and imaging procedures are standard of care; research procedures are limited to noninvasive postural/PM length measurements and structured data collection.
Participants Case group (n=45): Patients who underwent shoulder arthroscopy performed by Prof. Dr. Ulunay Kanatli and were found to have rotator cuff tears intraoperatively.
Control group (n=45): Patients presenting with shoulder pain whose rotator cuff was documented as intact by MRI and/or arthroscopy. This includes patients who underwent arthroscopy for labral, SLAP, or instability pathology without rotator cuff tear, and patients with MRI-confirmed intact rotator cuff.
Matching: Propensity score matching (nearest neighbor, caliper 0.2 SD) on age, sex, BMI, and dominant side using R MatchIt package.
Key exclusions: prior ipsilateral shoulder surgery; acute fracture/dislocation; major-trauma RCT; cervical radiculopathy/thoracic outlet syndrome; systemic inflammatory arthropathy; barriers to consent.
Study Procedures
Preoperative assessments (same-day or pre-op clinic):
- Pectoralis minor length (mm): Linear distance from coracoid tip to rib attachment measured with a digital caliper (ICC 0.83-0.87); three trials recorded; mean used for analysis.
- Medial scapular border-thoracic distance (mm) using digital calipers (ICC 0.88-0.97).
- Forward shoulder posture using a 300 mm square (ICC 0.89).
- Imaging abstraction: Standard shoulder radiographs and MRI summarized.
Intraoperative assessment (for arthroscopy patients):
Surgeons document tear initiation site (bursal vs articular) and tear characteristics using a standardized form based on video visualization.
Sample Size and Power Based on a conditional logistic regression framework: OR=3.0, alpha=0.05 (two-sided), power=0.80, with 10% dropout allowance. Total n=90 (45 case + 45 control).
Statistical Analysis Plan
- Software: IBM SPSS Statistics-26, R (MatchIt package)
- Normality: Shapiro-Wilk test
- Comparisons: Paired t-test / Wilcoxon / McNemar for matched pairs
- Multivariable: Conditional logistic regression
- Primary outcome: Presence of rotator cuff tear (case vs control) as a function of PM tightness
- Secondary outcome: Tear initiation site (bursal vs articular) as a function of PM length in the case group
- Significance level: two-sided alpha=0.05
Quality Assurance
- All measurements by a single trained investigator (intra-rater reliability)
- Video recordings retained for intraoperative assessment verification
- Data stored on encrypted drives (KVKK compliant)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Cagatay Delice
- Phone Number: +90 546 5819056
- Email: cgty_166@hotmail.com
Study Locations
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Cankaya
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Ankara, Cankaya, Turkey (Türkiye), 06500
- Recruiting
- Gazi University Hospital
-
Contact:
- Cagatay Delice
- Phone Number: +90 546 581 9056
- Email: cgty_166@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults 18 to 55 years old.
- Shoulder pain.
- Evaluated by MRI and/or shoulder arthroscopy.
- Willing to take part and give informed consent.
Exclusion Criteria:
- Previous surgery on the same shoulder.
- Recent traumatic shoulder injury such as fracture or dislocation.
- Rotator cuff tear due to major trauma.
- Neck/nerve conditions affecting the shoulder, such as cervical radiculopathy or thoracic outlet syndrome.
- Systemic inflammatory joint disease, such as rheumatoid arthritis or ankylosing spondylitis.
- Cognitive or communication problems that would prevent accurate measurements or consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Rotator Cuff Tear (Case)
Patients who underwent shoulder arthroscopy and were found to have rotator cuff tears during surgery.
Pectoralis minor length, medial scapular distance, and forward shoulder posture were measured preoperatively.
Propensity score matched 1:1 with the control group on age, sex, BMI, and dominant side.
|
|
Intact Rotator Cuff (Control)
Patients presenting with shoulder pain whose rotator cuff was documented as intact by MRI and/or intraoperative arthroscopy findings.
Includes patients who underwent arthroscopy for labral, SLAP, or instability pathology without rotator cuff tear, and patients with MRI-confirmed intact rotator cuff.
Propensity score matched 1:1 with the case group on age, sex, BMI, and dominant side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pectoralis minor muscle length difference between case and control groups
Time Frame: Preoperative assessment, Day 0
|
Comparison of pectoralis minor (PM) muscle length (mm) between patients with rotator cuff tears (case group) and patients with intact rotator cuffs (control group).
PM length is measured as the linear distance from coracoid tip to rib attachment using a digital caliper.
Primary analysis: conditional logistic regression evaluating whether PM tightness is associated with rotator cuff tear presence in propensity score matched pairs.
|
Preoperative assessment, Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forward shoulder posture
Time Frame: Preoperative assessment, Day 0
|
Anterior displacement of the acromion relative to the thorax measured with a square ruler (standardized upright position).
Three trials; mean used.
|
Preoperative assessment, Day 0
|
|
Medial Scapular Border Thoracic Distance
Time Frame: Preoperative assessment, Day 0
|
Periscapular prominence measured with calipers at the medial scapular border in standardized upright posture; three trials, mean used.
|
Preoperative assessment, Day 0
|
|
Thoracic Kyphosis (Cobb angle)
Time Frame: Preoperative imaging review, Day 0
|
Lateral thoracic radiograph measured using the Cobb method: superior endplate line of T5 and inferior endplate line of T12 (use closest visible end vertebrae if either is obscured).
Lines perpendicular to each endplate are drawn; the included angle is recorded as the thoracic kyphosis Cobb angle.
One trained assessor performs the measurement; a second assessor repeats it in a 15-case subset for reliability.
|
Preoperative imaging review, Day 0
|
|
Scapular index (Coracoid-Sternum/Acromian lateral tip - thoracic spine)
Time Frame: Preoperative assessment, Day 0
|
Ration of two linear distances measured with a digital caliper in standardized upright posture arms relaxed at sides.
Scapular Index = (Coracoid-Sternum) / (Acromion- Thoracic spine). Three trials per shoulder; the mean ratio is used for analysis. A 15-case subset will be re-measured by a second rater to assess inter-rater reliability. |
Preoperative assessment, Day 0
|
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Tear initiation site in the case group
Time Frame: Intraoperative, Day 0 (index arthroscopy)
|
Arthroscopic classification of the surface on which the rotator cuff tear appears to begin (bursal vs articular), recorded with a standardized intraoperative checklist in the case group only.
Analysis evaluates whether PM-tight patients more frequently exhibit bursal-side tear initiation compared to non-tight patients within the RCT group.
|
Intraoperative, Day 0 (index arthroscopy)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yamaguchi K, Ditsios K, Middleton WD, Hildebolt CF, Galatz LM, Teefey SA. The demographic and morphological features of rotator cuff disease. A comparison of asymptomatic and symptomatic shoulders. J Bone Joint Surg Am. 2006 Aug;88(8):1699-704. doi: 10.2106/JBJS.E.00835.
- Borstad JD. Measurement of pectoralis minor muscle length: validation and clinical application. J Orthop Sports Phys Ther. 2008 Apr;38(4):169-74. doi: 10.2519/jospt.2008.2723. Epub 2007 Nov 21.
- Ludewig PM, Reynolds JF. The association of scapular kinematics and glenohumeral joint pathologies. J Orthop Sports Phys Ther. 2009 Feb;39(2):90-104. doi: 10.2519/jospt.2009.2808.
- Cools AM, Struyf F, De Mey K, Maenhout A, Castelein B, Cagnie B. Rehabilitation of scapular dyskinesis: from the office worker to the elite overhead athlete. Br J Sports Med. 2014 Apr;48(8):692-7. doi: 10.1136/bjsports-2013-092148. Epub 2013 May 18.
- Kibler WB, McMullen J. Scapular dyskinesis and its relation to shoulder pain. J Am Acad Orthop Surg. 2003 Mar-Apr;11(2):142-51. doi: 10.5435/00124635-200303000-00008.
- Borstad JD, Ludewig PM. The effect of long versus short pectoralis minor resting length on scapular kinematics in healthy individuals. J Orthop Sports Phys Ther. 2005 Apr;35(4):227-38. doi: 10.2519/jospt.2005.35.4.227.
- Oyama S, Myers JB, Wassinger CA, Daniel Ricci R, Lephart SM. Asymmetric resting scapular posture in healthy overhead athletes. J Athl Train. 2008 Oct-Dec;43(6):565-70. doi: 10.4085/1062-6050-43.6.565.
- Peterson DE, Blankenship KR, Robb JB, Walker MJ, Bryan JM, Stetts DM, Mincey LM, Simmons GE. Investigation of the validity and reliability of four objective techniques for measuring forward shoulder posture. J Orthop Sports Phys Ther. 1997 Jan;25(1):34-42. doi: 10.2519/jospt.1997.25.1.34.
- Du WY, Huang TS, Hsu KC, Lin JJ. Measurement of scapular medial border and inferior angle prominence using a novel scapulometer: A reliability and validity study. Musculoskelet Sci Pract. 2017 Dec;32:120-126. doi: 10.1016/j.msksp.2017.08.004. Epub 2017 Aug 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-302.08.01-1273486
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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