- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05725356
Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain
February 9, 2023 updated by: Sattam Almutairi, Qassim University
Effectiveness of Physical Exercise on Job Stress and Quality of Life in Office Workers With Chronic Non-Specific Neck Pain: A Randomized Controlled Trial
Neck pain is a common medical condition among office workers all over the world.
The purpose of this study was to see if physical exercise, such as basic body awareness, neck-specific training exercises, and ergonomic modifications, could help reduce pain, disability, and job stress while also improving quality of life among office workers.
Participants will be assigned at random to either an experimental (exercise therapy and ergonomic modification) or a control group (ergonomic modification).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
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 Contact
- Name: Sattam M Almutairi
- Phone Number: +966505102644
- Email: A.sattam@qu.edu.sa
Study Locations
-
-
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Buraidah, Saudi Arabia
- Recruiting
- King Fahad Specialist Hospital
-
Contact:
- Sattam Almutairi
- Phone Number: 0505102644
-
-
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
25 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 25-60 years
- Greater than 3 months of chronic NSNP.
- Office workers and computer users
- The ability to continue working
Exclusion Criteria:
- A history of severe injury
- Previous physical therapy treatments
- Joint instability
- Frequent migraines
- Spasmodic torticollis
- Inflammatory rheumatic diseases
- Peripheral nerve entrapment
- Severe psychiatric illness
- Pregnancy
- Other conditions that prevent physical loading.
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 |
---|---|
EXPERIMENTAL: Experimental
Receiving physical exercise treatment (basic body awareness therapy and neck-specific training exercises) and ergonomic modification
|
Participants were instructed to focus on maintaining good posture, balance, uninterrupted breathing, increased awareness, and decreasing unnecessary muscle tension.
Other Names:
|
OTHER: Control
Receiving ergonomic modification only
|
Participants were instructed to focus on maintaining good posture, balance, uninterrupted breathing, increased awareness, and decreasing unnecessary muscle tension.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Pain Rating Scale
Time Frame: Change from baseline pain at 8 weeks
|
Used to assess pain intensity.
It uses the numbers from 0 to 10 and 0 indicates (no pain) through 1-3 (mild pain, slight impairment in daily life activities), 4-6 (moderate pain, substantial impairment in daily life activities), and 7-10 (severe pain, severe impairment in daily life activities).
|
Change from baseline pain at 8 weeks
|
Neck Disability Index
Time Frame: Change from baseline pain at 8 weeks
|
Patient's self-reported impairment due to neck pain.
It is a self-reported tool comprising 10 items.
Each item is graded on a 6-point scale ranging from 0 (no disability) to 5 (severe disability).
|
Change from baseline pain at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health and Safety Executive Management Standards Indicator Tool
Time Frame: Change from baseline pain at 8 weeks
|
Assessing psychosocial stress in the work area.
Thirty-five HSE-MS questions measure seven dimensions, including demands, control, supervisory support , peer support , relationships, role (including a clear understanding of the employee's role in the organization), and changes.
A higher score on each dimension (5 points) indicated lower stress.
|
Change from baseline pain at 8 weeks
|
The Short Form Health Survey
Time Frame: Change from baseline pain at 8 weeks
|
Used to measure the quality of life.
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Change from baseline pain at 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sattam M Almutairi, Physical Therapy Department, College of Medical Rehabilitation Sciences, Qassim University
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)
June 1, 2022
Primary Completion (ANTICIPATED)
June 1, 2023
Study Completion (ANTICIPATED)
June 1, 2023
Study Registration Dates
First Submitted
January 31, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (ACTUAL)
February 13, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UT-153-31-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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