Neck PainNCT05725356
Effectiveness of Physical Exercise on Chronic Non-Specific Neck Pain
A study testing Basic body awareness therapy in people with Neck Pain, run by Qassim University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Basic body awareness therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-60 years
- Greater than 3 months of chronic NSNP.
- Office workers and computer users
- The ability to continue working
Who cannot join
- A history of severe injury
- Previous physical therapy treatments
- Joint instability
- Frequent migraines
- Spasmodic torticollis
- Inflammatory rheumatic diseases
Show all 10Show fewer
- Peripheral nerve entrapment
- Severe psychiatric illness
- Pregnancy
- Other conditions that prevent physical loading.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahad Specialist Hospital
Buraidah
Sattam Almutairi, 0505102644
About this study
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
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).
- Conditions
- Neck Pain
- Being tested
- Basic body awareness therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic body awareness therapyOther
Also called ergonomic modification
Participants were instructed to focus on maintaining good posture, balance, uninterrupted breathing, increased awareness, and decreasing unnecessary muscle tension.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Receiving physical exercise treatment (basic body awareness therapy and neck-specific training exercises) and ergonomic modification Receives: Other: Basic body awareness therapy |
| Control | Other | Receiving ergonomic modification only Receives: Other: Basic body awareness therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline pain at 8 weeks
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).
Measured: Change from baseline pain at 8 weeks
Secondary outcomes (2)
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.
Measured: Change from baseline pain at 8 weeks
The Short Form Health Survey
Used to measure the quality of life.
Measured: Change from baseline pain at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tabuk
- Responsible party
- Principal investigator, Sattam Almutairi, Qassim University
- Investigators
- Sattam M Almutairi, Principal investigator, Physical Therapy Department, College of Medical Rehabilitation Sciences, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725356
- Sponsor's protocol ID
- UT-153-31-2021
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05725356
- Acronym / sponsor ID
- UT-153-31-2021
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- University of Tabuk
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Basic body awareness therapyReceiving physical exercise treatment (basic body awareness therapy and neck-specific training exercises) and ergonomic modification |
| Control | Other | Other: Basic body awareness therapyReceiving ergonomic modification only |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 25-60 years
- Greater than 3 months of chronic NSNP.
- Office workers and computer users
- The ability to continue working
Key exclusion criteria (10 listed)
- A history of severe injury
- Previous physical therapy treatments
- Joint instability
- Frequent migraines
- Spasmodic torticollis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic body awareness therapyAlso: ergonomic modificationParticipants were instructed to focus on maintaining good posture, balance, uninterrupted breathing, increased awareness, and decreasing unnecessary muscle tension. | Other | Control, Experimental |
Primary outcome
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).
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).
2 secondary outcomes
Health and Safety Executive Management Standards Indicator Tool
Time frame: Change from baseline pain at 8 weeks
The Short Form Health Survey
Time frame: Change from baseline pain at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sattam M Almutairi principal investigator
Physical Therapy Department, College of Medical Rehabilitation Sciences, Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic body awareness therapy in people with Neck Pain, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sattam M Almutairi (+966505102644, A.Sattam@qu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (time frame: Change from baseline pain at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.