Neck PainNCT05261854
Effect Of Pressure Biofeedback on Deep Cervical Muscle Training Among University Teachers.
A study testing Pressure biofeedback and Conventional exercises for deep cervical muscle training in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, Functional Disability and muscle endurance. Read more about this study
- Who is it for?
- Ages 24 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Pressure biofeedback and Conventional exercises for deep cervical muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2021to 5 Apr 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 24 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- age between 24 to 45 years
- At least 4 years of teaching experience and average 8 hours of working per day
- Chronic Neck pain score of more than 5 on numeric pain rating scale
- Mild to moderate disability Score on neck disability index
Who cannot join
- Participants with any ongoing treatment for neck pain
- History of cervical spine surgery or reported any neurological signs.
- History of any congenital or acquired postural deformity, spinal cord compression, tumour, instability, fracture, inflammatory disease or infection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Effects of Pressure Biofeedback on Deep Cervical Flexor Muscle Training for Neck Pain, Functional Disability and Muscle Endurance Among University Teachers. A Randomized Control Trail
The aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, Functional Disability and muscle endurance.
Read the detailed description
The purpose of this study will be to determine whether training of deep cervical flexor muscles with pressure biofeedback has any significant advantage over conventional training for pain and disability experienced by university teachers with neck pain. This study will be a randomized control trial with double blinded protocol. Patient will be randomly allocated in two groups. the experimental group received deep cervical flexor muscles training with pressure biofeedback and conventional exercises. The control group received deep cervical flexor muscles training with only conventional exercises.
- Conditions
- Neck Pain
- Being tested
- Pressure biofeedback, Conventional exercises for deep cervical muscle training
- Keywords
- Neck pain, Disabilty, Muscle endurance, Pressure biofeedback, Teachers
- 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 biofeedbackDevice
Deep cervical flexor training by using preesure biofeedback will be given 5 days a week for 6 week Conventional exercise for deep cervical muscle training will be given 5 days a week for 6 weeks
Conventional exercises for deep cervical muscle trainingOther
Conventional exercise for deep cervical muscle training will be given 4 days a week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Deep cervical muscle training using pressure biofeedback and conventional Exercises | Experimental | The duration of preesure biofeedback includes 3 sets in a session with 10 repetitions each with 2 minutes of rest between sets and 5 days a week for 6 weeks.
Conventional exercises like Stretching and strengthening of neck flexor muscles will include 10 repetitions, each held for 10s with rest of 2 minutes between sets. The session will be conducted for 6 weeks, 5 days a week. Receives: Device: Pressure biofeedback |
| conventional exercises for Neck pain | Experimental | Only conventional exercises like stretching and strengthening of neck flexor muscles will be given. Receives: Other: Conventional exercises for deep cervical muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating Scale
Numeric pain rating scale used to determine pain intensity experienced by individuals. It consist of a horizontal or vertical line with total of 11 numbers,ranging from 0 to 10. Where 0 indicates no pain while 10 is the worst pain.
Measured: 8th week
Inclinometer
It is an instrument used for measuring the angles of tilt,elevation and depression of an object with respect to gravity.
Measured: 8th week
Cranio-cervical flexion test
It is a clinical test of the anatomical action of the deep cervical flexor muscles. It could be described as a test of neuromotor control. The features assessed are the activation and isometric endurance of the deep cervical flexors
Measured: 8th week
Neck Disability index
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 May 2021
- Primary completion25 Mar 2022
- Study completion5 Apr 2022
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261854
- Sponsor's protocol ID
- REC-FSD-00246
- Status last verified
- Jun 2022
- First submitted
- 20 Feb 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure Biofeedback on Deep Cervical Flexor Muscle Training for Neck Pain, Functional Disability and Muscle Endurance Among University Teachers. A Randomized Control Trail
- ClinicalTrials.gov ID
- NCT05261854
- Acronym / sponsor ID
- REC-FSD-00246
- Conditions
- Neck Pain
- Keywords
- Neck pain, Disabilty, Muscle endurance, Pressure biofeedback, Teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 2 Mar 2022 (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.
The aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, Functional Disability and muscle endurance.
Detailed description
The purpose of this study will be to determine whether training of deep cervical flexor muscles with pressure biofeedback has any significant advantage over conventional training for pain and disability experienced by university teachers with neck pain. This study will be a randomized control trial with double blinded protocol. Patient will be randomly allocated in two groups. the experimental group received deep cervical flexor muscles training with pressure biofeedback and conventional exercises. The control group received deep cervical flexor muscles training with only conventional exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep cervical muscle training using pressure biofeedback and conventional Exercises | Experimental | Device: Pressure biofeedbackThe duration of preesure biofeedback includes 3 sets in a session with 10 repetitions each with 2 minutes of rest between sets and 5 days a week for 6 weeks. Conventional exercises like Stretching and strengthening of neck flexor muscles will include 10 repetitions, each held for 10s with rest of 2 minutes between sets. The session will be conducted for 6 weeks, 5 days a week. |
| conventional exercises for Neck pain | Experimental | Other: Conventional exercises for deep cervical muscle trainingOnly conventional exercises like stretching and strengthening of neck flexor muscles will be given. |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both gender
- age between 24 to 45 years
- At least 4 years of teaching experience and average 8 hours of working per day
- Chronic Neck pain score of more than 5 on numeric pain rating scale
- Mild to moderate disability Score on neck disability index
Key exclusion criteria (3 listed)
- Participants with any ongoing treatment for neck pain
- History of cervical spine surgery or reported any neurological signs.
- History of any congenital or acquired postural deformity, spinal cord compression, tumour, instability, fracture, inflammatory disease or infection.
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 biofeedbackDeep cervical flexor training by using preesure biofeedback will be given 5 days a week for 6 week Conventional exercise for deep cervical muscle training will be given 5 days a week for 6 weeks | Device | Deep cervical muscle training using pressure biofeedback and conventional Exercises |
| Conventional exercises for deep cervical muscle trainingConventional exercise for deep cervical muscle training will be given 4 days a week for 6 weeks | Other | conventional exercises for Neck pain |
Primary outcome
Numeric pain rating Scale
Time frame: 8th week
Numeric pain rating scale used to determine pain intensity experienced by individuals. It consist of a horizontal or vertical line with total of 11 numbers,ranging from 0 to 10. Where 0 indicates no pain while 10 is the worst pain.
Inclinometer
Time frame: 8th week
It is an instrument used for measuring the angles of tilt,elevation and depression of an object with respect to gravity.
Cranio-cervical flexion test
Time frame: 8th week
It is a clinical test of the anatomical action of the deep cervical flexor muscles. It could be described as a test of neuromotor control. The features assessed are the activation and isometric endurance of the deep cervical flexors
Neck Disability index
Time frame: 8th week
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
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 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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 Kashif study chair
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 Conventional exercises for deep cervical muscle training in people with Neck Pain, 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 5 inclusion and 3 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 Jun 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?
Numeric pain rating Scale (time frame: 8th week). The study lists 4 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 22 Jun 2022.