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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • National Yang-Ming University
      • Taipei, Taiwan
        • Cheng Hsin General Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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) :

  1. the patients with shoulder pain from 20 - 60 years old
  2. Active arm elevation close to 150 degrees
  3. Shoulder pain at least 3 months

Inclusion Criteria (healthy people) :

  1. the people from 20 - 40 years old
  2. no any symptoms or injuries on shoulder one year ago

Exclusion Criteria:

  1. Adhesive capsulitis
  2. Pathologies of cervical origin
  3. History of acute trauma, previous surgery, or fracture in the affected shoulder
  4. Corticoid injection in the last 3 months
  5. Platelet Rich Plasma injection in the last 1 year
  6. Other manual and exercise physical therapy in the last 6 weeks
  7. Anyone suffering from neurological diseases and nerve damage
  8. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: pectoralis minor intervention group
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.
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.
Procedure: shoulder strengthening group
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Measurement of pectoralis minor length: distance between coracoid process and fourth rib taken with a tape measure on resting position.
Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks
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
Change from baseline pectoralis minor index after 12 times intervention up to 6 weeks
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.
Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
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.
Change from baseline pectoralis minor tightness test II after 12 times intervention up to 6 weeks
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.
Change from baseline round shoulder posture test I after 12 times intervention up to 6 weeks
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.
Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
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 (°).
Change from baseline scapular kinematics after 12 times intervention up to 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Scores ranging from 0 (no pain) to 10 (maximum pain)
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
A maximum score of 100 indicates the worst possible condition
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
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.
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
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.
After 12 times intervention up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cheng-Hsin General Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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