Shoulder PainNCT05104060
The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain
A study testing pectoralis minor intervention group and shoulder strengthening group in people with Shoulder Pain and Shoulder Impingement, run by National Yang Ming Chiao Tung University at 2 sites in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Shoulder Impingement, Scapular Dyskinesis
- What is being tested?
- pectoralis minor intervention group and shoulder strengthening group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- 17 Nov 2021to 22 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- the patients with shoulder pain from 20 - 60 years old
- Active arm elevation close to 150 degrees
- Shoulder pain at least 3 months
- the people from 20 - 40 years old
- no any symptoms or injuries on shoulder one year ago
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Yang-Ming University
Taipei, 112
Cheng Hsin General Hospital
Taipei
About this study
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.
- Conditions
- Shoulder Pain, Shoulder Impingement, Scapular Dyskinesis
- Being tested
- pectoralis minor intervention group, shoulder strengthening group
- Keywords
- pectoralis minor length, pectoralis minor index, scapular kinematic
- Medical subject headings
- Shoulder Pain, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pectoralis minor intervention groupProcedure or surgery
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.
shoulder strengthening groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| pectoralis minor intervention group | Experimental | 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. Receives: Procedure: pectoralis minor intervention group |
| shoulder strengthening group | Active comparator | 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. Receives: Procedure: shoulder strengthening group |
| Healthy subject group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pectoralis minor length
Measurement of pectoralis minor length: distance between coracoid process and fourth rib taken with a tape measure on resting position.
Measured: Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks
Pectoralis minor index
The pectoralis minor length was divided by the participant's height and multiplied by 100 to calculate the pectoralis minor index
Measured: Change from baseline pectoralis minor index after 12 times intervention up to 6 weeks
Pectoralis minor tightness test I
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.
Measured: Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
Pectoralis minor tightness test II
Subjects will forward flexion 30 degrees,and pressed the coracoid process.If physical therapist felt tightness for positive.
Measured: Change from baseline pectoralis minor tightness test II after 12 times intervention up to 6 weeks
Round shoulder posture test I
Measured the distance between the posterior border of the acromion and the table surface.
Measured: Change from baseline round shoulder posture test I after 12 times intervention up to 6 weeks
Round shoulder posture test II
Measured the vertical distance between the posterior acromion and the treatment bed,then divided by thorax thickness and multiplied by 100.
Measured: Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
Scapular kinematics
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 (°).
Measured: Change from baseline scapular kinematics after 12 times intervention up to 6 weeks
Secondary outcomes (4)
Visual analog scale
Scores ranging from 0 (no pain) to 10 (maximum pain)
Measured: Change from baseline visual analog scale after 12 times intervention up to 6 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH)
A maximum score of 100 indicates the worst possible condition
Measured: Change from baseline DASH after 12 times intervention up to 6 weeks
Patient-Specific Functional Scale (PSFS)
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.
Measured: Change from baseline PSFS after 12 times intervention up to 6 weeks
Global rating of change (GRC)
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.
Measured: After 12 times intervention up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start17 Nov 2021
- Primary completion12 Aug 2022
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Responsible party
- Principal investigator, Yin-Liang Lin, National Yang Ming Chiao Tung University
- Investigators
- Yin-Liang Lin, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104060
- Sponsor's protocol ID
- YM110136E
- Status last verified
- Mar 2023
- First submitted
- 28 Sep 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain
- ClinicalTrials.gov ID
- NCT05104060
- Acronym / sponsor ID
- YM110136E
- Conditions
- Shoulder Pain, Shoulder Impingement, Scapular Dyskinesis
- Keywords
- pectoralis minor length, pectoralis minor index, scapular kinematic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Cheng-Hsin General Hospital
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pectoralis minor intervention group | Experimental | Procedure: pectoralis minor intervention groupThe 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. |
| shoulder strengthening group | Active comparator | Procedure: shoulder strengthening groupThe 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. |
| Healthy subject group | No intervention | –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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- the patients with shoulder pain from 20 - 60 years old
- Active arm elevation close to 150 degrees
- Shoulder pain at least 3 months
- the people from 20 - 40 years old
- no any symptoms or injuries on shoulder one year ago
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pectoralis minor intervention groupThe 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. | Procedure or surgery | pectoralis minor intervention group |
| shoulder strengthening groupThe 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. | Procedure or surgery | shoulder strengthening group |
Primary outcome
Pectoralis minor length
Time frame: Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks
Measurement of pectoralis minor length: distance between coracoid process and fourth rib taken with a tape measure on resting position.
Pectoralis minor index
Time frame: Change from baseline pectoralis minor index after 12 times intervention up to 6 weeks
The pectoralis minor length was divided by the participant's height and multiplied by 100 to calculate the pectoralis minor index
Pectoralis minor tightness test I
Time frame: Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
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.
Pectoralis minor tightness test II
Time frame: Change from baseline pectoralis minor tightness test II after 12 times intervention up to 6 weeks
Subjects will forward flexion 30 degrees,and pressed the coracoid process.If physical therapist felt tightness for positive.
Round shoulder posture test I
Time frame: Change from baseline round shoulder posture test I after 12 times intervention up to 6 weeks
Measured the distance between the posterior border of the acromion and the table surface.
Round shoulder posture test II
Time frame: Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
Measured the vertical distance between the posterior acromion and the treatment bed,then divided by thorax thickness and multiplied by 100.
Scapular kinematics
Time frame: Change from baseline scapular kinematics after 12 times intervention up to 6 weeks
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 (°).
4 secondary outcomes
Visual analog scale
Time frame: Change from baseline visual analog scale after 12 times intervention up to 6 weeks
Disabilities of the Arm, Shoulder, and Hand (DASH)
Time frame: Change from baseline DASH after 12 times intervention up to 6 weeks
Patient-Specific Functional Scale (PSFS)
Time frame: Change from baseline PSFS after 12 times intervention up to 6 weeks
Global rating of change (GRC)
Time frame: After 12 times intervention up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin-Liang Lin, PhD principal investigator
National Yang Ming Chiao Tung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pectoralis minor intervention group and shoulder strengthening group in people with Shoulder Pain and Shoulder Impingement, run by National Yang Ming Chiao Tung University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pectoralis minor length (time frame: Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.