- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05104060
The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain
March 22, 2023 updated by: Yin-Liang Lin, National Yang Ming University
Shoulder pain is the third common problem, after problems of spine.
Abnormal scapular kinematics, so called scapular dyskinesis, is believed to be associated with shoulder pain.
Studies showed that individuals with shoulder problems demonstrate less upward rotation, posterior tilt and external rotation during shoulder movement.
The shortness of the pectoralis minor (PM) is one of the factors leading to scapular dyskinesis.
Short pectoralis minor has been shown to prevent scapula from tilting posterior and rotating externally during shoulder motion.
The decreased scapular posterior tilt and external rotation may decrease subacromial space and result in impingement.
However, although many assessment methods have been used to assess PM tightness or shortness, no study has tested the validity of these testing methods.
Moreover, although stretching exercises for PM have been shown to increase the PM length, previous studies found that PM stretching exercises did not restore scapular kinematics and did not further decrease pain and improve function.
Shoulder pain and discomfort has also been reported during stretching.
Therefore, rather than stretching exercise, other types of treatment that can specifically increase the PM length and restore scapular kinematics may be needed.
Manual therapy could specifically increase the flexibility of PM, and scapular orientation exercises could improve scapular kinematics.
These types of treatment may be better options.
However, to our knowledge, no study has investigated whether manual therapy combined with scapular orientation exercises could improve scapular kinematics, pain and function.
Therefore, the first part of this study is to investigate which tests for length or tightness of PM can predict the scapular dyskinesis.
The second part of the study is to investigate the effects of manual therapy and scapular orientation training on PM length, scapular kinematics, pain, and function in subjects with shoulder pain.
In the first part of the study, 67 healthy subjects will be recruited.
In the second part, 62 patients with shoulder pain will be recruited and randomized into either a PM treatment group or a control group.
While no treatment will be provided for the healthy subjects in the first part, subjects with shoulder pain in the second part will receive 12 sessions of treatment in 4-6weeks, with 30-40 minutes per session.
Patients in the control group will receive general shoulder strengthening exercise, while patients in the PM treatment group will have additional manual therapy and scapular orientation exercise.
The measures include tests of PM length, scapular kinematics in the first and second parts, and pain and shoulder disability were also additionally assessed in the second part.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yin-Liang Lin, PhD
- Phone Number: +886-2-2826-7288
- Email: yllin1020@nycu.edu.tw
Study Contact Backup
- Name: Yi-zhen Li, BS
- Phone Number: 0983125066
- Email: a0983125066@gmail.com
Study Locations
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Taipei, Taiwan, 112
- National Yang-Ming University
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Taipei, Taiwan
- Cheng Hsin General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria(patients with shoulder pain) :
- the patients with shoulder pain from 20 - 60 years old
- Active arm elevation close to 150 degrees
- Shoulder pain at least 3 months
Inclusion Criteria (healthy people) :
- the people from 20 - 40 years old
- no any symptoms or injuries on shoulder one year ago
Exclusion Criteria:
- Adhesive capsulitis
- Pathologies of cervical origin
- History of acute trauma, previous surgery, or fracture in the affected shoulder
- Corticoid injection in the last 3 months
- Platelet Rich Plasma injection in the last 1 year
- Other manual and exercise physical therapy in the last 6 weeks
- Anyone suffering from neurological diseases and nerve damage
- Vulnerable subjects
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pectoralis minor intervention group
The participants in pectoralis minor group will received manual therapy for pectoralis minor by investigators, the technique including stretch and soft tissue mobilization.
The participants asked to perform the scapular control exercise and shoulder strength exercise.
Participants will be correct scapular resting position and then do elevation in scapular plane.Four exercises for shoulder strength will do shoulder flexion, abduction, internal and external rotation with thera-band.
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The subjects in pectoralis minor group will received manual therapy for pectoralis minor by physical therapist, the technique including stretch and soft tissue mobilization.
The subjects asked to perform the scapular control exercise and shoulder strength exercise.Subjects will be correct scapular resting position and then do elevation in scapular plane.Four exercises for shoulder strength will do shoulder flexion, abduction, internal and external rotation with thera-band.
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Active Comparator: shoulder strengthening group
The participants in the scapular strengthening group will be asked to do four exercises for shoulder strength, including shoulder flexion, abduction, internal and external rotation with thera-band.
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The subjects in the scapular strengthening group will be asked to do four exercises for shoulder strength, including shoulder flexion, abduction, internal and external rotation with thera-band.
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No Intervention: Healthy subject group
Healthy participants will be recruited.
No Intervention will be provided.
The correlation between measures of pectoralis minor length and scapular kinematics will be assessed.
Measurement will be the same as pectoralis minor intervention group and shoulder strengthening group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pectoralis minor length
Time Frame: Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks
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Measurement of pectoralis minor length: distance between coracoid process and fourth rib taken with a tape measure on resting position.
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Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks
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Pectoralis minor index
Time Frame: Change from baseline pectoralis minor index after 12 times intervention up to 6 weeks
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The pectoralis minor length was divided by the participant's height and multiplied by 100 to calculate the pectoralis minor index
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Change from baseline pectoralis minor index after 12 times intervention up to 6 weeks
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Pectoralis minor tightness test I
Time Frame: Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
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Pressed the coracoid process of the subjects to make the scapula flat on the treatment bed.If flat the bed for negative,unable to flat the bed for positive.
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Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
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Pectoralis minor tightness test II
Time Frame: Change from baseline pectoralis minor tightness test II after 12 times intervention up to 6 weeks
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Subjects will forward flexion 30 degrees,and pressed the coracoid process.If physical therapist felt tightness for positive.
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Change from baseline pectoralis minor tightness test II after 12 times intervention up to 6 weeks
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Round shoulder posture test I
Time Frame: Change from baseline round shoulder posture test I after 12 times intervention up to 6 weeks
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Measured the distance between the posterior border of the acromion and the table surface.
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Change from baseline round shoulder posture test I after 12 times intervention up to 6 weeks
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Round shoulder posture test II
Time Frame: Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
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Measured the vertical distance between the posterior acromion and the treatment bed,then divided by thorax thickness and multiplied by 100.
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Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
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Scapular kinematics
Time Frame: Change from baseline scapular kinematics after 12 times intervention up to 6 weeks
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Scapular kinematics, including anterior/posterior tilt, upward/downward rotation, and internal/external rotation in scapula plan elevation at 30°, 60°, 90°, and 120°, will be calculated and will be described with degree (°).
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Change from baseline scapular kinematics after 12 times intervention up to 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: Change from baseline visual analog scale after 12 times intervention up to 6 weeks
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Scores ranging from 0 (no pain) to 10 (maximum pain)
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Change from baseline visual analog scale after 12 times intervention up to 6 weeks
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Disabilities of the Arm, Shoulder, and Hand (DASH)
Time Frame: Change from baseline DASH after 12 times intervention up to 6 weeks
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A maximum score of 100 indicates the worst possible condition
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Change from baseline DASH after 12 times intervention up to 6 weeks
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Patient-Specific Functional Scale (PSFS)
Time Frame: Change from baseline PSFS after 12 times intervention up to 6 weeks
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Identify 3 important activities that they were unable to perform.
A minimum score of 0 is unable to engage in these activities, and a maximum score of 10 can still perform these activities as efficiently as before without shoulder pain.
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Change from baseline PSFS after 12 times intervention up to 6 weeks
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Global rating of change (GRC)
Time Frame: After 12 times intervention up to 6 weeks
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Independently score self-perceived improvement in a patient.
A minimum score of -5 is the worse situation compared to before treatment.
Compared to before treatment, a score of 0 means no change.Compared to before treatment, a score of 5 means full recovery.
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After 12 times intervention up to 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2021
Primary Completion (Actual)
August 12, 2022
Study Completion (Actual)
March 22, 2023
Study Registration Dates
First Submitted
September 28, 2021
First Submitted That Met QC Criteria
October 22, 2021
First Posted (Actual)
November 2, 2021
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YM110136E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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