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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04144764
Other study ID # 2019.269
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2019
Est. completion date September 30, 2022

Study information

Verified date November 2020
Source Chinese University of Hong Kong
Contact Hio Teng Leong, PhD
Phone (852)35053535
Email annieleonght@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives: (1) To examine the upper trapezius muscle stiffness using SSI in workers with and without neck/shoulder disorders; and (2) to develop a workplace-based exercise programme to reduce upper trapezius muscle stiffness and to enhance shoulder function and work ability in the working population. Hypotheses to be tested: (1) Workers with neck/shoulder disorders demonstrate increase upper trapezius muscle stiffness when compared to healthy control; and a cutoff value of the upper trapezius stiffness was established for early identification of individuals at risk of having neck/shoulder disorders in the working population; (2) Workplace-based exercise programme can reduce upper trapezius muscle stiffness and enhance shoulder function and work ability in the working population. Design: Part A study: Cross-sectional study; Part B study: randomized controlled trial Subjects: One-hundred office computer workers with or without neck/shoulder pain Study instruments: Supersonic shear wave imaging Main outcome measures: Upper trapezius muscle stiffness, Shoulder Pain and Disability Index (SPADI), Neck Disability Index, Disability of the Arm, Shoulder and Hand (DASH), work ability index (WAI). Data analysis: Between-group comparisons to show differences in the outcome measures will be analyzed using Independent t-test. To compare the treatment effects, repeated-measures analysis of variance test (between-group factor: intervention vs control; within-subject factor: time (baseline, 6 week and 1 year)). Expected results: Workers with neck/shoulder disorders demonstrate increase upper trapezius muscle stiffness when compared to healthy control. Workplace-based exercise programme can reduce upper trapezius muscle stiffness and enhance shoulder function and work ability in the working population.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Office computer workers who worked for a minimum of four hours per day using a computer - With or without neck/shoulder pian Exclusion Criteria: - Involved regular strength training of the neck/upper extremities within the past 12 months; - history of whiplash, neck/upper limb fractures, previous surgery and previous clinical treatment for a neck/upper limb injury within the last 12 months; - Fibromyalgia; - Pregnancy; - Neurological disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Workplace-based exercise
Participants will have to perform 10-week of workplace-based exercise programme which consist of 5 sessions of 10 minutes per week. The workplace-based exercise programme will consist of general stretching and strengthening exercise using resistance tubing for both the neck and upper limb. Specific rotator cuff and scapular muscles strengthening exercise were also included to enhance glenohumeral and scapular kinematics (Appendix). Each participant will receive a set of elastic resistance tubing that comprise red (2kg), green (3kg) and blue (4kg). The exercise programme will be taught by physiotherapist during their baseline assessment. They will be asked to train at the workplace during workdays (Monday to Friday), five times a week during the 10-week intervention. The program built on the principle of progressive overload.
Ergonomic advice and education
Participants will receive ergonomic training and education on how to adjust their workstations to reduce the ergonomic risk factors when using computers.

Locations

Country Name City State
Hong Kong CUHK-ORT Sports Injury Research Laboratory Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Upper trapezius muscle stiffness Supersonic shear wave imaging of the upper trapezius muscles 0, 10-weeks and 1-year
Secondary Change in Shoulder Pain and Disability Score The Chinese Version of the Shoulder Pain and Disability Index (SPADI) questionnaire is a validated self-administered questionnaire to evaluate the shoulder pain and disability scores. The questionnaire consists of 13 items with 2 subscales: pain (5 items) and disability (8 items); and the total final score that range from 0 to 100, with higher scores indicate more disability. 0, 10-weeks and 1-year
Secondary Change in Functional score The Chinese Version of the Neck Disability Index and Disability of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire are reliable and validated self-administered questionnaire to evaluate the neck and upper extremity function. The total score is divided by number of answered questions, subtracted 1 and multiplied by 25, in a scale score that range from 0 to 100, with higher scale scores indicate more disability. 0, 10-weeks and 1-year
Secondary Change in Work ability The work ability index (WAI) questionnaire will be used to evaluate the work ability. It composes of 7 items that evaluate: 1) current work ability compared with lifetime best; 2) work ability in relation to job demand; 3) number of current diagnosed disorders; 4) estimated work impairment due to disease; 5) sick leave during the past 12 months; 6) own prognosis of work ability; and 7) mental capacities. The score ranged between 7 to 49, with higher scores indicate better work ability. 0, 10-weeks and 1-year
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