NCT05205369

Brief Summary

Shoulder pain is the third most common type of musculoskeletal disorder after back and neck pain in primary care. The prevalence of shoulder pain has been reported between 7% and 26% in the general population, with a life prevalence of up to 67%. The most common cause of shoulder pain is subacromial pain syndrome (SAPS), accounting for 44-60% of all shoulder disorders. Pain caused by SAPS can cause functional impairment and heavy social burden. Before recommending surgery, exercise therapy should be used as the first choice to treat SAPS. Several systematic reviews suggested that supervised exercise therapy can effectively improve the function and pain of patients with SAPS, while several other systematic reviews illustrated that the equal effectiveness of supervised exercises and home-based exercises. Supervised exercise therapy requires substantial and specific resources and may be difficult to apply clinically. Thus, a home-based self-training program may allow individuals to treat SAPS with affordable and easily accessible treatments. The use of complementary and alternative medicine treatment is growing continuously. Yi Jin Bang is a form of mind-body exercise and was developed in Hong Kong in the 1950s based on the principle of traditional Chinese mind-body exercise "Yi Jin Jing". In Chinese, Yi means change, Jin means tendons and sinews, while Bang means stick. As with all other Chinese medical exercises, the focus of Yi Jin Bang is on the cultivation of Qi (energy), which is assumed to harmonize mind and body and so might reduce pain. After reorganizing by physiotherapists, Yi Jin Bang has now become an easy-to-learn exercise program. Many scientific studies have demonstrated the effectiveness of mind-body exercises on pain, such as yoga, Tai Chi, and Qigong. However, the efficacy of Yi Jin Bang exercise in SAPS is not scientifically evaluated. Therefore, the purpose of the present study is to compare the effectiveness of ten weeks of home-based Yi Jin Bang exercise, versus home-based stretching and strengthening exercise, and versus waitlist control on pain, disability, flexibility, and muscular endurance in adults with SAPS. This study hypothesized that home-based Yi Jin Bang exercise and home-based stretching and strengthening exercise have similar effects in reducing pain and disability and improving flexibility and muscular endurance for individuals with SAPS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

December 20, 2021

Last Update Submit

February 7, 2023

Conditions

Keywords

shoulder disordersrehabilitationexercise therapyself-trainingmind-body exerciserandomized controlled trial

Outcome Measures

Primary Outcomes (5)

  • Functional disability

    Functional disability will be measured using the Shoulder Pain and Disability Index (SPADI). This is a self-reported questionnaire assessing pain and functional status, which consists of five questions regarding pain and eight questions regarding disability. Each question is scored from 0 to 10, and the total score ranges from 0 to 100. Greater scores represent higher levels of pain and disability.

    Measures will be conducted at baseline

  • Functional disability

    Functional disability will be measured using the Shoulder Pain and Disability Index (SPADI). This is a self-reported questionnaire assessing pain and functional status, which consists of five questions regarding pain and eight questions regarding disability. Each question is scored from 0 to 10, and the total score ranges from 0 to 100. Greater scores represent higher levels of pain and disability.

    Measures will be conducted at 10 weeks

  • Pain intensity

    Pain intensity will be measured on an 11 points numerical rating scale. Participants will be asked to place a vertical mark on a horizontal line to indicate their current pain degree in rest and activity, where 0 for no pain and 10 for unbearable pain.

    Measures will be conducted at baseline

  • Pain intensity

    Pain intensity will be measured on an 11 points numerical rating scale. Participants will be asked to place a vertical mark on a horizontal line to indicate their current pain degree in rest and activity, where 0 for no pain and 10 for unbearable pain.

    Measures will be conducted after the first exercise session during the first week of training

  • Pain intensity

    Pain intensity will be measured on an 11 points numerical rating scale. Participants will be asked to place a vertical mark on a horizontal line to indicate their current pain degree in rest and activity, where 0 for no pain and 10 for unbearable pain.

    Measures will be conducted at 10 weeks

Secondary Outcomes (6)

  • Flexibility

    Measures will be conducted at baseline

  • Flexibility

    Measures will be conducted after the first exercise session during the first week of training

  • Flexibility

    Measures will be conducted at 10 weeks

  • Muscular endurance

    Measures will be conducted at baseline

  • Muscular endurance

    Measures will be conducted after the first exercise session during the first week of training

  • +1 more secondary outcomes

Study Arms (3)

Yi Jin Bang group

EXPERIMENTAL

Participants in this group will perform a 10-week home-based Yi Jin Bang exercise program.

Behavioral: 10-week home-based Yi Jin Bang exercise program

Usual exercise therapy group

EXPERIMENTAL

Participants in this group will perform a 10-week home-based usual exercise therapy program.

Behavioral: 10-week home-based usual exercise therapy program

Waitlist control group

NO INTERVENTION

Participants in the waitlist control group will be informed that they will receive either Yi Jin Bang training or exercise therapy after ten weeks have passed. This will be done only for motivational reasons and not for evaluation.

Interventions

Each participant in this group will do a home-based Yi Jin Bang exercise program four times a week for ten consecutive weeks, which consists of ten minutes of warm-up, 18 minutes of Yi Jin Bang exercise (ten exercises), and ten minutes of cool-down. To learn how to conduct the home-based exercise session, each participant will be invited to one introductory session before starting the prescribed exercise program. Two experienced Yi Jin Bang instructors will lead the introductory session. Besides, in order to monitor participants' adherence and help them to conduct self-training, we will use the Zoom Meeting application. Zoom can capture and record participants' movements through the webcam. During the introduction sessions, we will teach participants how to use Zoom. Furthermore, we will provide support for adherence to the home exercise sessions through telephone calls or e-mail every two weeks.

Yi Jin Bang group

Among exercise therapy in the treatment of SAPS, stretching and strengthening protocols are often used . Therefore, participants in this group will do a standardized home-based stretching and strengthening exercise program four times per week for ten weeks, which is set up according to a previous study. This program has been demonstrated that can be effective in reducing pain and improving function in patients with SAPS. For strengthening exercises, elastic bands will be used. To learn how to conduct the self-training program, each participant in this group will also be invited to one introductory session before starting the prescribed exercise training. Two certificated physiotherapists will lead the introductory session. In addition, a video demonstration clip will be given to each participant to provide a home reference, and the Zoom Meeting application will be used to help monitor the exercise.

Usual exercise therapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 to 65 years old
  • pain during overhead activities
  • pain during active movements of the shoulder
  • pain in the last three months
  • Hawkins-Kennedy impingement test positive
  • painful arc test positive
  • infraspinatus muscle test positive

You may not qualify if:

  • a history of fracture-dislocation of the shoulder
  • full-thickness rotator cuff tear
  • a history of shoulder surgery
  • inflammatory of the vertebrae
  • shoulder trauma in the last month
  • any physical treatment for shoulder pain in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

  • Stanley Sai-chuen Hui, EdD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 25, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 15, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations