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Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain

Primary Purpose

Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Basic body awareness therapy
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Fahad Specialist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Receiving physical exercise treatment (basic body awareness therapy and neck-specific training exercises) and ergonomic modification

Receiving ergonomic modification only

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale
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).
Neck Disability Index
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).

Secondary Outcome Measures

Health and Safety Executive Management Standards Indicator Tool
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.
The Short Form Health Survey
Used to measure the quality of life.

Full Information

First Posted
January 31, 2023
Last Updated
February 9, 2023
Sponsor
Qassim University
Collaborators
University of Tabuk
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1. Study Identification

Unique Protocol Identification Number
NCT05725356
Brief Title
Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain
Official Title
Effectiveness of Physical Exercise on Job Stress and Quality of Life in Office Workers With Chronic Non-Specific Neck Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
University of Tabuk

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Receiving physical exercise treatment (basic body awareness therapy and neck-specific training exercises) and ergonomic modification
Arm Title
Control
Arm Type
Other
Arm Description
Receiving ergonomic modification only
Intervention Type
Other
Intervention Name(s)
Basic body awareness therapy
Other Intervention Name(s)
ergonomic modification
Intervention Description
Participants were instructed to focus on maintaining good posture, balance, uninterrupted breathing, increased awareness, and decreasing unnecessary muscle tension.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
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).
Time Frame
Change from baseline pain at 8 weeks
Title
Neck Disability Index
Description
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).
Time Frame
Change from baseline pain at 8 weeks
Secondary Outcome Measure Information:
Title
Health and Safety Executive Management Standards Indicator Tool
Description
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.
Time Frame
Change from baseline pain at 8 weeks
Title
The Short Form Health Survey
Description
Used to measure the quality of life.
Time Frame
Change from baseline pain at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sattam M Almutairi
Phone
+966505102644
Email
A.Sattam@qu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sattam M Almutairi
Organizational Affiliation
Physical Therapy Department, College of Medical Rehabilitation Sciences, Qassim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Fahad Specialist Hospital
City
Buraidah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sattam Almutairi
Phone
0505102644

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain

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