Forward Head PostureNCT06151951
Comparative Effects of Visual and Pressure Biofeedback in Symptomatic Forward Head Posture.
A study testing Cervical Stabilization, Pressure Biofeedback and Visual Biofeedback in people with Forward Head Posture, run by Riphah International University at 2 sites in Pakistan.
Trial summary
This study aims to determined the comparative effect of visual and pressure biofeedback on Pain,Disability and Range of Motion in young and middle aged adults diagnosed with forward head posture. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- Cervical Stabilization, Pressure Biofeedback and Visual Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesPakistan
- Study dates
- 10 May 2023to 10 Jan 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Participants would be complaining of neck pain as a primary complain and age of 20- 35 year was recruited in the study .
- 2 . Male and female both gender are included in the study.
- 3. patient with Craniovertebral angle (CVA)<53 degree were included in the study .
- 4. Score more than 3 on NPRS and more than 10 on NDI.
Who cannot join
- Participant failing to fall in this category would be excluded of the study.
- Neurogenic findings like cervical trauma, myopathy, vestibular pathology, dizziness, visual problem, spinal Fracture, dislocation and hypertension will not include in the study.
- History of sever metabolic diseases.
- History of recurrent surgery in upper thoracic and lumber vertebrae
- History of recent fractures in shoulder and neck region.
- History of tumor. -
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Bahawal Victoria Hospital QAMC Bahawalpur
Bahawalpur, Punjab Province, 63100
Hafiz Irshad Ahmad, MS, 0333-6352593, hafizirshad728@gmail.com
Nusrat Prveen
- Recruiting
Bahawal Victoria Hospital QAMC Bahawalpur
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
Hafiz Irshad Ahmad, 9250460, hafizirshad728@gmail.com
Hafiz Irshad Ahmad, 0333-6352593, hafizirshad728@gmail.com
About this study
Official title: Comparative Effects of Visual and Pressure Biofeedback on Pain, Range of Motion and Disability in Symptomatic Forward Head Posture.
This study aims to determined the comparative effect of visual and pressure biofeedback on Pain,Disability and Range of Motion in young and middle aged adults diagnosed with forward head posture.
Read the detailed description
Forward head posture describes the shifting of the head forward with the chin poking out. It is caused by increased flexion of the lower cervical spine and upper thoracic.
Forward head posture is the most frequently observed postural deviations and is said to be associated with shortening of posterior cervical extensors and weakening of the anterior deep cervical flexors. In this randomized control trial participants showing forward head posture will be randomly assigned into two intervention groups. 28 subjects were divided equally into two groups 14 each containing both genders. Group A (Experimental group) will be given isometric strengthening and stretching training guided pressure biofeedback.
Group B (Experimental group) will be given isometric strengthening and stretching training of deep cervical flexor (DCF) muscle guided through visual biofeedback .
Each participant will be receive a total of twelve treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session) and conclusion (last session) of the treatment period. The assessment will encompass various outcome measures. Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS), while disability levels will be measured using the Neck Disability Index (NDI). The cervical active range of motions (CAROMs) will be assessed by goniometry. Finally, the visual feedback referred as indicator of measuring forward head posture by evaluating these outcome measures insights will be gained into the impact of the interventions on the participants' symptoms and postural alignment through light. The randomized design of the trial provide valuable information to healthcare professionals on how to manage symptomatic forward head posture and may contribute to the development of future research in this area.
- Conditions
- Forward Head Posture
- Being tested
- Cervical Stabilization, Pressure Biofeedback, Visual Biofeedback
- Keywords
- FHP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical StabilizationOther
Isometric stretching and strengthening exercises of Neck flexor muscle including suboccipitalis, levator scapulae,scalnae anterior and upper trapezius. Each exercise hold for 6 second and then release and repeated 10 times respectively 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints.
Pressure BiofeedbackDevice
In this method patients in supine position. Sphygmomanometer is used and 100 mmHg pressure will be maintained before the treatment start then cuff will be placed under the occiopit of spine and patient will be asked to press the cuff against the occiopit until gauze show target pressure then hold this position for 6 second and release. Repeated this pressure to 10 times, 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints.
Baseline Treatment
Before starting the session participants received moist heat pack and soft tissue massage on cervical for 10 to 15 mints followed by movement control training.
Visual BiofeedbackDevice
In this method Led Head Band light will be used as a visual feedback. Patients in sitting or standing position with neck straight with the alignment of front wall marking followed by control movement training. Patient will be asked to follow the marking through head band light while performing motion control training. Each exercise hold for 6 second and then release and repeated 10 times respectively 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints.
Baseline Treatment
Before starting the session participants received moist heat pack and soft tissue massage on cervical for 10 to 15 mints followed by movement control training.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Movement control training of Neck flexor muscles with Pressure Biofeedback along with baseline treatment Receives: Other: Cervical Stabilization; Device: Pressure Biofeedback |
| Group B | Experimental | Movement control training of Neck flexor muscles with Visual Biofeedback along with baseline treatment Receives: Other: Cervical Stabilization; Device: Visual Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'. Participants select the whole number that best represents their level of pain. The reliability is >0.95 with ICC values 0.86- 0.95
Measured: 4 weeks
Neck Disability Index (NDI)
NDI is a self-reported questionnaire which is formulated to assess pain that restricts the activities of daily living (ADL); it also helps to determine self-assessed disability. NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Scores range from 0 to 50, with 50 being the greatest levels of dysfunction. It is a valid and reliable tool with ICC=0.98
Measured: 4 weeks
Pressure Biofeedback (Simple Sphygmomanometer)
It is used to measure the neck muscle strength. It was consisting of 3 chamber air filled pressure bag, a catheter \& sphygmomanometer gauze. To measure the strength, cuff is placed under occipital in supine position for Neck flexor and under forehead in prone position for neck extensor muscle. After setting pressure with the baseline Pressure of 100 mmHg, patient was asked to put maximum effort on cuff by giving 6 seconds hold for 3 repetitions. After taking the mean value, it is compared with the normal extensor flexor.
Measured: 4 weeks
Secondary outcomes (2)
Visual Biofeedback (LED Headband light)
This light is known as light panel that contain rectangular shape light focusing panel that maintain the focus through manual adjustment.
Measured: 4 weeks
goniometry
A goniometer is a device that measures an angle or permits the rotation of an object to a definite position. In orthopedics, the former description applies more. It is valid and reliable tool for measuring range of motion.
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 Nov 2023
- Study start10 May 2023
- Primary completion10 Dec 2023 (estimated)
- Study completion10 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies 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
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, Principal investigator, Riphah International UniversityNusrat Prveen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151951
- Sponsor's protocol ID
- REC/RCR&AHS/23/0154
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2023
- Last updated
- 30 Nov 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Visual and Pressure Biofeedback on Pain, Range of Motion and Disability in Symptomatic Forward Head Posture.
- ClinicalTrials.gov ID
- NCT06151951
- Acronym / sponsor ID
- REC/RCR&AHS/23/0154
- Conditions
- Forward Head Posture
- Keywords
- FHP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 10 Jan 2024 (estimated)
- First posted
- 30 Nov 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.
This study aims to determined the comparative effect of visual and pressure biofeedback on Pain,Disability and Range of Motion in young and middle aged adults diagnosed with forward head posture.
Detailed description
Forward head posture describes the shifting of the head forward with the chin poking out. It is caused by increased flexion of the lower cervical spine and upper thoracic.
Forward head posture is the most frequently observed postural deviations and is said to be associated with shortening of posterior cervical extensors and weakening of the anterior deep cervical flexors. In this randomized control trial participants showing forward head posture will be randomly assigned into two intervention groups. 28 subjects were divided equally into two groups 14 each containing both genders. Group A (Experimental group) will be given isometric strengthening and stretching training guided pressure biofeedback.
Group B (Experimental group) will be given isometric strengthening and stretching training of deep cervical flexor (DCF) muscle guided through visual biofeedback .
Each participant will be receive a total of twelve treatment sessions over a four-week period. The efficacy of the interventions will be assessed at the beginning (first session) and conclusion (last session) of the treatment period. The assessment will encompass various outcome measures. Pain intensity will be evaluated using the Numeric Pain Rating Scale (NPRS), while disability levels will be measured using the Neck Disability Index (NDI). The cervical active range of motions (CAROMs) will be assessed by goniometry. Finally, the visual feedback referred as indicator of measuring forward head posture by evaluating these outcome measures insights will be gained into the impact of the interventions on the participants' symptoms and postural alignment through light. The randomized design of the trial provide valuable information to healthcare professionals on how to manage symptomatic forward head posture and may contribute to the development of future research in this area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Cervical Stabilization, Device: Pressure BiofeedbackMovement control training of Neck flexor muscles with Pressure Biofeedback along with baseline treatment |
| Group B | Experimental | Other: Cervical Stabilization, Device: Visual BiofeedbackMovement control training of Neck flexor muscles with Visual Biofeedback along with baseline treatment |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Participants would be complaining of neck pain as a primary complain and age of 20- 35 year was recruited in the study .
- 2 . Male and female both gender are included in the study.
- 3. patient with Craniovertebral angle (CVA)<53 degree were included in the study .
- 4. Score more than 3 on NPRS and more than 10 on NDI.
Key exclusion criteria (6 listed)
- Participant failing to fall in this category would be excluded of the study.
- Neurogenic findings like cervical trauma, myopathy, vestibular pathology, dizziness, visual problem, spinal Fracture, dislocation and hypertension will not include in the study.
- History of sever metabolic diseases.
- History of recurrent surgery in upper thoracic and lumber vertebrae
- History of recent fractures in shoulder and neck region.
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 |
|---|---|---|
| Cervical StabilizationIsometric stretching and strengthening exercises of Neck flexor muscle including suboccipitalis, levator scapulae,scalnae anterior and upper trapezius. Each exercise hold for 6 second and then release and repeated 10 times respectively 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints. | Other | Group A, Group B |
| Pressure BiofeedbackIn this method patients in supine position. Sphygmomanometer is used and 100 mmHg pressure will be maintained before the treatment start then cuff will be placed under the occiopit of spine and patient will be asked to press the cuff against the occiopit until gauze show target pressure then hold this position for 6 second and release. Repeated this pressure to 10 times, 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints. Baseline Treatment Before starting the session participants received moist heat pack and soft tissue massage on cervical for 10 to 15 mints followed by movement control training. | Device | Group A |
| Visual BiofeedbackIn this method Led Head Band light will be used as a visual feedback. Patients in sitting or standing position with neck straight with the alignment of front wall marking followed by control movement training. Patient will be asked to follow the marking through head band light while performing motion control training. Each exercise hold for 6 second and then release and repeated 10 times respectively 3 times in a week for 4 weeks. Therefore, the total exercise time will be 5-10 mints. Baseline Treatment Before starting the session participants received moist heat pack and soft tissue massage on cervical for 10 to 15 mints followed by movement control training. | Device | Group B |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4 weeks
The NPRS is a subjective pain rating scale using an 11-point scale from 0 to 10, where 0 means 'no pain' and 10 means 'intolerable pain'. Participants select the whole number that best represents their level of pain. The reliability is >0.95 with ICC values 0.86- 0.95
Neck Disability Index (NDI)
Time frame: 4 weeks
NDI is a self-reported questionnaire which is formulated to assess pain that restricts the activities of daily living (ADL); it also helps to determine self-assessed disability. NDI has 10 domains covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Scores range from 0 to 50, with 50 being the greatest levels of dysfunction. It is a valid and reliable tool with ICC=0.98
Pressure Biofeedback (Simple Sphygmomanometer)
Time frame: 4 weeks
It is used to measure the neck muscle strength. It was consisting of 3 chamber air filled pressure bag, a catheter \& sphygmomanometer gauze. To measure the strength, cuff is placed under occipital in supine position for Neck flexor and under forehead in prone position for neck extensor muscle. After setting pressure with the baseline Pressure of 100 mmHg, patient was asked to put maximum effort on cuff by giving 6 seconds hold for 3 repetitions. After taking the mean value, it is compared with the normal extensor flexor.
2 secondary outcomes
Visual Biofeedback (LED Headband light)
Time frame: 4 weeks
goniometry
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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.
Ali Raza principal investigator
Riphah International University
Nusrat Prveen principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Stabilization, Pressure Biofeedback and Visual Biofeedback in people with Forward Head Posture, run by Riphah International University at 2 sites 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 6 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjid, PHD (+923324390125, imran.amlid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 4 weeks). The study lists 3 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 30 Nov 2023.