- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07266610
Effects of Neck Stabilizers Retraining on Chronic Neck Pain (PBU)
Effects of Deep Neck Stabilizers Retraining With Pressure Biofeedback on Cervical Pain, Range of Motion and Temporomandibular Dysfunction in Patients With Chronic Neck Pain
The present study aims to evaluate the effects of deep neck stabilizers retraining with pressure biofeedback on cervical range of motion, pain, and temporomandibular dysfunction in patients with chronic neck pain.
Participants will receive biofeedback-assisted deep neck flexor retraining in one group, while the other group will perform conventional exercises. The neurological connection between the TMJ and neck means that therapies such as neck flexion exercises and biofeedback can alleviate neck pain and jaw issues.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Pakistan Society for the Rehabilitation of the Disabled (PSRD)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis: Chronic neck pain (duration more than 3 months and less than 1 year and 6 months)
- TMJ Dysfunction (RCD TMJ Axis I Confirmation on Helkino Index) Fonseca Anamnestic Index (FAI) 20-65 score mild to moderate
Exclusion Criteria:
- Traumatic neck injury
- Neurological disorders
- Cervical spine infection or surgery
- Cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group 1 (Biofeedback-assisted deep neck flexor retraining )
Each session includes TENS and hot pack therapy, crook lying exercises with a 20 mmHg pressure biofeedback sensor, the Cranio-Cervical Flexion Test, and neck and shoulder stretches.
Data will be collected at the initial point, after 3 weeks, and once more at the 6-week point.
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The experimental group will receive deep neck stabilizer training with pressure biofeedback and traditional exercises for six weeks, three times weekly.
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Active Comparator: Group 2 (Conventional exercises)
Each session begins with TENS and hot pack therapy, followed by stretching and strengthening exercises for neck and shoulder muscles.
Data will be collected at the initial point, after 3 weeks, and once more at the 6-week point.
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The control group will engage in a traditional exercise program for 6 weeks, meeting three times weekly
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temporomandibular dysfunction
Time Frame: 6 weeks
|
Mandibular Functional Impairment Questionnaire
|
6 weeks
|
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Pain Intensity
Time Frame: 6 weeks
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Numeric Pain Rating Scale will be used
|
6 weeks
|
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Cervical Range of Motion
Time Frame: 6 weeks
|
Inclinometer
|
6 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sikka I, Chawla C, Seth S, Alghadir AH, Khan M. Effects of Deep Cervical Flexor Training on Forward Head Posture, Neck Pain, and Functional Status in Adolescents Using Computer Regularly. Biomed Res Int. 2020 Oct 5;2020:8327565. doi: 10.1155/2020/8327565. eCollection 2020.
- Alagingi NK. Chronic neck pain and postural rehabilitation: A literature review. J Bodyw Mov Ther. 2022 Oct;32:201-206. doi: 10.1016/j.jbmt.2022.04.017. Epub 2022 Apr 20.
- Aguiar ADS, Nogueira Carrer HC, de Lira MR, Martins Silva GZ, Chaves TC. Patient-Reported Outcome Measurements in Temporomandibular Disorders and Headaches: Summary of Measurement Properties and Applicability. J Clin Med. 2021 Aug 26;10(17):3823. doi: 10.3390/jcm10173823.
- Craciun MD, Geman O, Leuciuc FV, Holubiac IS, Gheorghita D, Filip F. Effectiveness of Physiotherapy in the Treatment of Temporomandibular Joint Dysfunction and the Relationship with Cervical Spine. Biomedicines. 2022 Nov 17;10(11):2962. doi: 10.3390/biomedicines10112962.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/024
- U1111-1331-6077 (Registry Identifier: WHO Universal Trial Number)
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
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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