Quantification of Upper Trapezius Muscle Stiffness Using Supersonic Shear Wave Imaging: Efficacy of Workplace-based Exercise Programme to Reduce Neck and Shoulder Disorders in Working Population

November 10, 2020 updated by: LEONG Hio Teng, Chinese University of Hong Kong

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • CUHK-ORT Sports Injury Research Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control group
Participants will receive ergonomic training and education on how to adjust their workstations to reduce the ergonomic risk factors when using computers.
EXPERIMENTAL: Workplace-based exercise group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Upper trapezius muscle stiffness
Time Frame: 0, 10-weeks and 1-year
Supersonic shear wave imaging of the upper trapezius muscles
0, 10-weeks and 1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Shoulder Pain and Disability Score
Time Frame: 0, 10-weeks and 1-year
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
Change in Functional score
Time Frame: 0, 10-weeks and 1-year
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
Change in Work ability
Time Frame: 0, 10-weeks and 1-year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 9, 2019

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (ACTUAL)

October 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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