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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104060
• Other study ID #: YM110136E
• Status: Completed
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: March 22, 2023

Study information

• Verified date: March 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 22, 2023
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Scapular Dyskinesis
• Shoulder Impingement
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Cheng Hsin General Hospital	Taipei
Taiwan	National Yang-Ming University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pectoralis minor length	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
Primary	Pectoralis minor index	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
Primary	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.	Change from baseline pectoralis minor tightness test I after 12 times intervention up to 6 weeks
Primary	Pectoralis minor tightness test II	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
Primary	Round shoulder posture test I	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
Primary	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.	Change from baseline round shoulder posture test II after 12 times intervention up to 6 weeks
Primary	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 (°).	Change from baseline scapular kinematics after 12 times intervention up to 6 weeks
Secondary	Visual analog scale	Scores ranging from 0 (no pain) to 10 (maximum pain)	Change from baseline visual analog scale after 12 times intervention up to 6 weeks
Secondary	Disabilities of the Arm, Shoulder, and Hand (DASH)	A maximum score of 100 indicates the worst possible condition	Change from baseline DASH after 12 times intervention up to 6 weeks
Secondary	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.	Change from baseline PSFS after 12 times intervention up to 6 weeks
Secondary	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.	After 12 times intervention up to 6 weeks