Isometric Exercises With and Without Pressure Biofeedback in Computer Users With Cervical Spine Overload
Primary Purpose
Pain, Neck
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
pressure biofeedback
isometric exercises
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Neck
Eligibility Criteria
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)
Sites / Locations
- Muhammad Hahim
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
biofeedback
isometric exercises
Arm Description
10 patients will be treated with isometric exercises and pressure biofeedback.
10 patients will be treated with isometric exercises without pressure biofeedback.
Outcomes
Primary Outcome Measures
pain of patient
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).
function
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05026086
First Posted
August 23, 2021
Last Updated
April 21, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05026086
Brief Title
Isometric Exercises With and Without Pressure Biofeedback in Computer Users With Cervical Spine Overload
Official Title
Effects of Isometric Exercises With and Without Pressure Biofeedback on Cervical Pain and Muscle Strength in Computer Users With Cervical Spine Overload
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biofeedback
Arm Type
Experimental
Arm Description
10 patients will be treated with isometric exercises and pressure biofeedback.
Arm Title
isometric exercises
Arm Type
Active Comparator
Arm Description
10 patients will be treated with isometric exercises without pressure biofeedback.
Intervention Type
Other
Intervention Name(s)
pressure biofeedback
Intervention Description
10 patients will be treated with isometric exercises and pressure biofeedback.
Intervention Type
Other
Intervention Name(s)
isometric exercises
Intervention Description
10 patients will be treated with isometric exercises
Primary Outcome Measure Information:
Title
pain of patient
Description
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).
Time Frame
4 weeks
Title
function
Description
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)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Salman Bashir, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhammad Hahim
City
Lahore
State/Province
Ppunjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28807894
Citation
Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
Results Reference
background
PubMed Identifier
31594480
Citation
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.
Results Reference
background
PubMed Identifier
28602744
Citation
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.
Results Reference
background
PubMed Identifier
22764450
Citation
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.
Results Reference
background
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Isometric Exercises With and Without Pressure Biofeedback in Computer Users With Cervical Spine Overload
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