Pain, NeckNCT05026086
Isometric Exercises With and Without Pressure Biofeedback in Computer Users With Cervical Spine Overload
A study testing pressure biofeedback and isometric exercises in people with Pain, Neck, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Pain, Neck
- What is being tested?
- pressure biofeedback and isometric exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2021to 28 Feb 2022
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- History of cervical trauma
- Postural deformity
- Spinal cord deformity ( scoliosis, kyphosis, lordosis)
- Current pregnancy
- Significant neurological deficits ( cervical radiculopathy, cervical spondylosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain, Neck
- Being tested
- pressure biofeedback, isometric exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure biofeedbackOther
10 patients will be treated with isometric exercises and pressure biofeedback.
isometric exercisesOther
10 patients will be treated with isometric exercises
| Study group | Role | What they receive |
|---|---|---|
| biofeedback | Experimental | 10 patients will be treated with isometric exercises and pressure biofeedback. Receives: Other: pressure biofeedback |
| isometric exercises | Active comparator | 10 patients will be treated with isometric exercises without pressure biofeedback. Receives: Other: isometric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
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)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start5 Aug 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Salman Bashir, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026086
- Sponsor's protocol ID
- REC/RCR&AHS/21/0115
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28807894Barrett 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.
PubMed 31594480Genebra 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.
PubMed 28602744Khan 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.
PubMed 22764450
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isometric Exercises With and Without Pressure Biofeedback on Cervical Pain and Muscle Strength in Computer Users With Cervical Spine Overload
- ClinicalTrials.gov ID
- NCT05026086
- Acronym / sponsor ID
- REC/RCR&AHS/21/0115
- Conditions
- Pain, Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 30 Aug 2021 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback | Experimental | Other: pressure biofeedback10 patients will be treated with isometric exercises and pressure biofeedback. |
| isometric exercises | Active comparator | Other: isometric exercises10 patients will be treated with isometric exercises without pressure biofeedback. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- History of cervical trauma
- Postural deformity
- Spinal cord deformity ( scoliosis, kyphosis, lordosis)
- Current pregnancy
- Significant neurological deficits ( cervical radiculopathy, cervical spondylosis)
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 |
|---|---|---|
| pressure biofeedback10 patients will be treated with isometric exercises and pressure biofeedback. | Other | biofeedback |
| isometric exercises10 patients will be treated with isometric exercises | Other | isometric exercises |
Primary outcome
pain of patient
Time frame: 4 weeks
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
Time frame: 4 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 28807894Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- Background: PubMed 31594480Barrett 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.
- Background: PubMed 28602744Genebra 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.
- Background: PubMed 22764450Khan 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.
- 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.
Muhammad Salman Bashir, PhD principal investigator
Riphah International 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 pressure biofeedback and isometric exercises in people with Pain, Neck, run by Riphah International University at 1 site in Pakistan.
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 5 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: finished, as of the sponsor's last update on 22 Apr 2022. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain of patient (time frame: 4 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?
On the ClinicalTrials.gov record for NCT05026086, which also lists 4 linked publications.
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 22 Apr 2022.