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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

Primary Purpose

Neck Pain, Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Workplace-based exercise
Ergonomic advice and education
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring upper trapezius, muscle stiffness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CUHK-ORT Sports Injury Research LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Workplace-based exercise group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Change in Upper trapezius muscle stiffness
Supersonic shear wave imaging of the upper trapezius muscles

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 24, 2019
Last Updated
November 10, 2020
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04144764
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Shoulder Pain
Keywords
upper trapezius, muscle stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Workplace-based exercise group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Workplace-based exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ergonomic advice and education
Intervention Description
Participants will receive ergonomic training and education on how to adjust their workstations to reduce the ergonomic risk factors when using computers.
Primary Outcome Measure Information:
Title
Change in Upper trapezius muscle stiffness
Description
Supersonic shear wave imaging of the upper trapezius muscles
Time Frame
0, 10-weeks and 1-year
Secondary Outcome Measure Information:
Title
Change in Shoulder Pain and Disability Score
Description
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.
Time Frame
0, 10-weeks and 1-year
Title
Change in Functional score
Description
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.
Time Frame
0, 10-weeks and 1-year
Title
Change in Work ability
Description
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.
Time Frame
0, 10-weeks and 1-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hio Teng Leong, PhD
Phone
(852)35053535
Email
annieleonght@cuhk.edu.hk
Facility Information:
Facility Name
CUHK-ORT Sports Injury Research Laboratory
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hio Teng Leong, PhD
Phone
(852) 35053535
Email
annieleonght@cuhk.edu.hk

12. IPD Sharing Statement

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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

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