- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05026086
Isometric Exercises With and Without Pressure Biofeedback in Computer Users With Cervical Spine Overload
Effects of Isometric Exercises With and Without Pressure Biofeedback on Cervical Pain and Muscle Strength in Computer Users With Cervical Spine Overload
Neck pain is defined as the pain experienced from the base of the skull or occiput to the upper part of the back and extending laterally to the outer and superior bounds of the shoulder blade. Office work is a kind of job that demands sitting for prolonged time requiring the use of computer. These two factors are mainly responsible for overloading of the spine. Neck pain and computer users are clearly connected due to extended periods of sitting in a certain position with no breaks to stretch the neck muscles. Prolonged computer use with neck bent forward will cause the anterior neck muscles to gradually get shorter and tighter, while the muscles in the back of neck will grow longer and weaker. These changes will lead to development of neck pain. Neck problem also accounts for a large proportion of occupational illness and disability. Neck pain is common among computer workers in our country and contributes importantly to the demand for medical services and the economic burden of absence from work due to sickness.
The main purpose of this randomized clinical trial will be to find out the effects of Isometric exercises with and without Pressure Biofeedback Unit on Cervical pain and Muscle strength in Computer users with cervical spine overload. Patients will be recruited in the study by convenient sampling technique after that will be allocated to groups by simple random assignment with an inclusion criteria having chronic neck pain for more than 3 months, current pain level ranging greater than 3 on NPRS, patient with minimum and moderate disability and male and female computer users with age 25 to 40 years with cervical pain. Patients with history of cervical trauma, postural deformity, spinal cord deformity, current pregnancy and significant neurological deficits were excluded.
Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI) will be used to measure before and after treatment session. Treatment will be given to both groups for 4 weeks and each group will receive 3 sessions per week. After collecting the data it will entered and analysed using Statistical Package for the Social Sciences (SPSS) version 25. Data will be assessed by using parametric/ non parametric test after completion of the study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ppunjab
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Lahore, Ppunjab, Pakistan, 54000
- Muhammad Hahim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 20-40 years among male and female with cervical pain
- Having chronic pain for more than 3 months.
- Current pain level ranging greater than 3 on NPRS
- Patients with minimum and moderate disability based on NDI
Exclusion Criteria:
- History of cervical trauma
- Postural deformity
- Spinal cord deformity ( scoliosis, kyphosis, lordosis)
- Current pregnancy
- Significant neurological deficits ( cervical radiculopathy, cervical spondylosis)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: biofeedback
10 patients will be treated with isometric exercises and pressure biofeedback.
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10 patients will be treated with isometric exercises and pressure biofeedback.
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Active Comparator: isometric exercises
10 patients will be treated with isometric exercises without pressure biofeedback.
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10 patients will be treated with isometric exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain of patient
Time Frame: 4 weeks
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NPRS The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale.
The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
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4 weeks
|
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function
Time Frame: 4 weeks
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Neck Disability index (NDI) Item scores range from 0 to 5, and the total score is a total of the item scores (possible range 0 (no pain) - 100 (maximal pain)
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Salman Bashir, PhD, Riphah International University
Publications and helpful links
General Publications
- Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
- Barrett JM, McKinnon C, Callaghan JP. Cervical spine joint loading with neck flexion. Ergonomics. 2020 Jan;63(1):101-108. doi: 10.1080/00140139.2019.1677944. Epub 2019 Oct 15.
- Khan R, Surti A, Rehman R, Ali U. Knowledge and practices of ergonomics in computer users. J Pak Med Assoc. 2012 Mar;62(3):213-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/21/0115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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