Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06107270
• Collaborator: (none)
• Enrollment: 45
• Arms: 3
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

This study will be conducted to explore the superiority of effectiveness between Muscle energy technique combined with Deep Neck Flexors training, MET alone, or DNF training alone in terms of pain intensity, neck function, forward head posture, cervical range of motion and Deep Neck Flexors Muscles endurance in patients with chronic mechanical neck pain(CMNP).

Condition or Disease	Intervention/Treatment	Phase
Deep Neck Flexors Training; Post Isometric Relaxation	Device: pressure biofeedback; Device: therapeutic ultra sound; Device: infra red radiation; Other: post isometric relaxation	N/A

Detailed Description

Patients will be grouped into three groups; each group composed of 15 patients suffering from CMNP. The personal history of each patient who participated in the study will be collected, the patient will receive an oral explanation of the procedures and signed a consent form . The weight and height of each patient will be obtained using the standard weight scale. The pain intensity level will be assessed via a visual analogue scale (VAS). The disability level will be assessed via neck disability index (NDI). The forward head posture will be assessed via photographic method of Craniovertebral angle (CVA) and the angle will be calculated by using kinovea software. The range of motion will be assessed via universal goniometer (UG). The endurance of the neck muscles will be assessed via pressure biofeedback unit (PBU). Assessment will be done before treatment and after 12 treatment sessions.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group A (n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks). Group B (n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) Group C (n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks)Group A (n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks). Group B (n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks) Group C (n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks)
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: All the patients will be blinded to group allocation by ensuring that they were unaware of the exercise performed by the other group. To maintain the blinding, the intervention sessions will be delivered separately to members of each treatment group, The allocation will be conducted by another researcher before the baseline.
• Primary Purpose: Treatment
• Official Title: Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (n=15) will be treated by Post Isometric Relaxation, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks).	Device: therapeutic ultra sound; continuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power; Device: infra red radiation; (R 125, 250watt, Philips); Other: post isometric relaxation; sustained contraction followed by relaxation
Experimental: Group B (n=15) will be treated by DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks)	Device: pressure biofeedback; uninflated pressure sensor will be kept below the neck suboccipital; Device: therapeutic ultra sound; continuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power; Device: infra red radiation; (R 125, 250watt, Philips)
Experimental: Group C (n=15) will be treated by Post Isometric Relaxation combined DNF training, infrared radiation and continuous ultrasound for 12 sessions (3 sessions per week for four weeks)	Device: pressure biofeedback; uninflated pressure sensor will be kept below the neck suboccipital; Device: therapeutic ultra sound; continuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power; Device: infra red radiation; (R 125, 250watt, Philips); Other: post isometric relaxation; sustained contraction followed by relaxation

Outcome Measures

Primary Outcome Measures

1. pain severity [4 weeks]

   Visual Analogue Scale It is a 10 cm or 100 mm psychometric response scale to measure pain intensity based on numerical values, anchored by a score of 0 no pain and score 10 worst pain The patient will be asked to place a horizontal mark on the continuous 10 cm line in which they could feel. A ruler will be then used to measure the distance from zero and the recorded number will be rounded to the nearest number Visual Analogue Scale .It is a 10 cm or 100 mm anchored by a score of 0 no pain and score 10 worst pain

2. functional disability [4 weeks]

   Neck Disability Index . 0% means no activity limitation, and 50 points or 100% means complete activity limitation

3. Deep Neck Flexors muscle endurance [4 weeks]

   Pressure biofeedback unit . used for muscular assessment of longus colli and longus capitus.

Secondary Outcome Measures

1. craniovertebral angle (CVA) [4 weeks]

   Kinovea (version 0.9.5) will be used to calculate the CVA

2. cervical range of motion [4 weeks]

   Universal goniometer.to measure the active cervical range of motion in all directions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age group 20-40 years of female and male patient.

2. Patient with neck pain duration more than 3 months and less than one year.

3. Subjects who could not maintain blood pressure at increments of 24 mmHg from the initial 20 mm Hg

4. Patients who have moderate neck pain and disability scoring 15 to 24 from 50 on neck disability index. .

5. Pain intensity more than 3 and less than 7 on visual analogue scale (VAS)

6. CVA less than 49°

Exclusion Criteria:

1. People with severe neck pain. (Disability scoring more than 25 on Neck Disability Index)

2. If they are participated in a neck rehabilitation program over the last 6 months

3. Major circulatory or respiratory disorder

4. Pregnant women or 3 months postnatal

5. Patient with structural instability and degenerative conditions of cervical spine.

6. Body Mass Index more than 30.

7. Post traumatic or infective conditions.

8. Any surgeries around cervical spine

9. Vertigo patient

10. Un-cooperative patient (Gupta et al., 2022).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Mohammed Hamed Sherif, Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain, Cairo University
• ClinicalTrials.gov Identifier: NCT06107270
• Other Study ID Numbers: DNFT+PIR technique
• First Posted: Oct 30, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neck Pain

Study Results

No Results Posted as of Nov 1, 2023