NCT05104060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

September 28, 2021

Last Update Submit

March 22, 2023

Conditions

Keywords

pectoralis minor lengthpectoralis minor indexscapular kinematic

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Visual analog scale

    Change from baseline visual analog scale after 12 times intervention up to 6 weeks

  • Disabilities of the Arm, Shoulder, and Hand (DASH)

    Change from baseline DASH after 12 times intervention up to 6 weeks

  • Patient-Specific Functional Scale (PSFS)

    Change from baseline PSFS after 12 times intervention up to 6 weeks

  • Global rating of change (GRC)

    After 12 times intervention up to 6 weeks

Study Arms (3)

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.

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.

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

Interventions

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.

pectoralis minor intervention 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.

shoulder strengthening group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Yang-Ming University

Taipei, 112, Taiwan

Location

Cheng Hsin General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Shoulder PainShoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsShoulder InjuriesWounds and Injuries

Study Officials

  • Yin-Liang Lin, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

November 2, 2021

Study Start

November 17, 2021

Primary Completion

August 12, 2022

Study Completion

March 22, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations