NCT04144764

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

November 9, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

October 24, 2019

Last Update Submit

November 10, 2020

Conditions

Keywords

upper trapeziusmuscle stiffness

Outcome Measures

Primary Outcomes (1)

  • Change in Upper trapezius muscle stiffness

    Supersonic shear wave imaging of the upper trapezius muscles

    0, 10-weeks and 1-year

Secondary Outcomes (3)

  • Change in Shoulder Pain and Disability Score

    0, 10-weeks and 1-year

  • Change in Functional score

    0, 10-weeks and 1-year

  • Change in Work ability

    0, 10-weeks and 1-year

Study Arms (2)

Workplace-based exercise group

EXPERIMENTAL
Other: Workplace-based exercise

Control group

SHAM COMPARATOR
Other: Ergonomic advice and education

Interventions

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.

Workplace-based exercise group

Participants will receive ergonomic training and education on how to adjust their workstations to reduce the ergonomic risk factors when using computers.

Control group

Eligibility Criteria

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

You may qualify if:

  • Office computer workers who worked for a minimum of four hours per day using a computer
  • With or without neck/shoulder pian

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK-ORT Sports Injury Research Laboratory

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neck PainShoulder Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Hio Teng Leong, PhD

CONTACT

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
Research Assistant Professor

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 30, 2019

Study Start

November 9, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations