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The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain

Primary Purpose

Shoulder Pain, Shoulder Impingement, Scapular Dyskinesis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
pectoralis minor intervention group
shoulder strengthening group
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring pectoralis minor length, pectoralis minor index, scapular kinematic

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Yang-Ming University
  • Cheng Hsin General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

pectoralis minor intervention group

shoulder strengthening group

Healthy subject group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Pectoralis minor length
Measurement of pectoralis minor length: distance between coracoid process and fourth rib taken with a tape measure on resting position.
Pectoralis minor index
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
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
Subjects will forward flexion 30 degrees,and pressed the coracoid process.If physical therapist felt tightness for positive.
Round shoulder posture test I
Measured the distance between the posterior border of the acromion and the table surface.
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.
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 (°).

Secondary Outcome Measures

Visual analog scale
Scores ranging from 0 (no pain) to 10 (maximum pain)
Disabilities of the Arm, Shoulder, and Hand (DASH)
A maximum score of 100 indicates the worst possible condition
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.
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.

Full Information

First Posted
September 28, 2021
Last Updated
March 22, 2023
Sponsor
National Yang Ming University
Collaborators
Cheng-Hsin General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05104060
Brief Title
The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain
Official Title
The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
August 12, 2022 (Actual)
Study Completion Date
March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
Collaborators
Cheng-Hsin General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Impingement, Scapular Dyskinesis
Keywords
pectoralis minor length, pectoralis minor index, scapular kinematic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pectoralis minor intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
shoulder strengthening group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy subject group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
pectoralis minor intervention group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
shoulder strengthening group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pectoralis minor length
Description
Measurement of pectoralis minor length: distance between coracoid process and fourth rib taken with a tape measure on resting position.
Time Frame
Change from baseline pectoralis minor length after 12 times intervention up to 6 weeks
Title
Pectoralis minor index
Description
The pectoralis minor length was divided by the participant's height and multiplied by 100 to calculate the pectoralis minor index
Time Frame
Change from baseline pectoralis minor index after 12 times intervention up to 6 weeks
Title
Pectoralis minor tightness test I
Description
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.
Time Frame
Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
Title
Pectoralis minor tightness test II
Description
Subjects will forward flexion 30 degrees,and pressed the coracoid process.If physical therapist felt tightness for positive.
Time Frame
Change from baseline pectoralis minor tightness test II after 12 times intervention up to 6 weeks
Title
Round shoulder posture test I
Description
Measured the distance between the posterior border of the acromion and the table surface.
Time Frame
Change from baseline round shoulder posture test I after 12 times intervention up to 6 weeks
Title
Round shoulder posture test II
Description
Measured the vertical distance between the posterior acromion and the treatment bed,then divided by thorax thickness and multiplied by 100.
Time Frame
Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
Title
Scapular kinematics
Description
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 (°).
Time Frame
Change from baseline scapular kinematics after 12 times intervention up to 6 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale
Description
Scores ranging from 0 (no pain) to 10 (maximum pain)
Time Frame
Change from baseline visual analog scale after 12 times intervention up to 6 weeks
Title
Disabilities of the Arm, Shoulder, and Hand (DASH)
Description
A maximum score of 100 indicates the worst possible condition
Time Frame
Change from baseline DASH after 12 times intervention up to 6 weeks
Title
Patient-Specific Functional Scale (PSFS)
Description
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.
Time Frame
Change from baseline PSFS after 12 times intervention up to 6 weeks
Title
Global rating of change (GRC)
Description
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.
Time Frame
After 12 times intervention up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Liang Lin, PhD
Organizational Affiliation
National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Cheng Hsin General Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Manual Therapy and Scapular Exercise for the Pectoralis Minor in Individuals With Shoulder Pain

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