- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06151951
Comparative Effects of Visual and Pressure Biofeedback in Symptomatic Forward Head Posture.
Comparative Effects of Visual and Pressure Biofeedback on Pain, Range of Motion and Disability in Symptomatic Forward Head Posture.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjid, PHD
- Phone Number: +923324390125
- Email: imran.amlid@riphah.edu.pk
Study Contact Backup
- Name: Imran amjid, PHD
- Phone Number: 051-5481826
- Email: imran.amlid@riphah.edu.pk
Study Locations
-
-
Punjab
-
Bahawalpur, Punjab, Pakistan, 63100
- Recruiting
- Bahawal Victoria Hospital QAMC Bahawalpur
-
Contact:
- Hafiz Irshad Ahmad, MS
- Phone Number: 0333-6352593
- Email: hafizirshad728@gmail.com
-
Principal Investigator:
- Nusrat Prveen
-
Bahāwalpur, Punjab, Pakistan, 63100
- Recruiting
- Bahawal Victoria Hospital QAMC Bahawalpur
-
Principal Investigator:
- Nusrat Prveen
-
Contact:
- Hafiz Irshad Ahmad
- Phone Number: 9250460
- Email: hafizirshad728@gmail.com
-
Contact:
- Hafiz Irshad Ahmad
- Phone Number: 0333-6352593
- Email: hafizirshad728@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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. -
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 |
|---|---|
|
Experimental: Group A
Movement control training of Neck flexor muscles with Pressure Biofeedback along with baseline treatment
|
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.
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. |
|
Experimental: Group B
Movement control training of Neck flexor muscles with Visual Biofeedback along with baseline treatment
|
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.
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 weeks
|
|
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
|
4 weeks
|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Biofeedback (LED Headband light)
Time Frame: 4 weeks
|
This light is known as light panel that contain rectangular shape light focusing panel that maintain the focus through manual adjustment.
|
4 weeks
|
|
goniometry
Time Frame: 4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Raza, Riphah International University
- Principal Investigator: Nusrat Prveen, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- REC/RCR&AHS/23/0154
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
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