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

NCT06107270 | Unknown

• 1 other identifier: DNFT+PIR technique
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Deep Neck Flexors Training; Post Isometric Relaxation

Outcome Measures

Primary Outcomes (3)

• pain severity

  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

  4 weeks

• functional disability

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

  4 weeks

• Deep Neck Flexors muscle endurance

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

  4 weeks

Secondary Outcomes (2)

• craniovertebral angle (CVA)

  4 weeks

• cervical range of motion

  4 weeks

Study Arms (3)

Group A

EXPERIMENTAL

(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; Device: infra red radiation; Other: post isometric relaxation

Group B

EXPERIMENTAL

(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; Device: therapeutic ultra sound; Device: infra red radiation

Group C

EXPERIMENTAL

(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; Device: therapeutic ultra sound; Device: infra red radiation; Other: post isometric relaxation

Interventions

pressure biofeedback DEVICE

uninflated pressure sensor will be kept below the neck suboccipital

Group B; Group C

therapeutic ultra sound DEVICE

continuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power

Group A; Group B; Group C

infra red radiation DEVICE

(R 125, 250watt, Philips)

Group A; Group B; Group C

post isometric relaxation OTHER

sustained contraction followed by relaxation

Group A; Group C

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group 20-40 years of female and male patient.
• Patient with neck pain duration more than 3 months and less than one year.
• Subjects who could not maintain blood pressure at increments of 24 mmHg from the initial 20 mm Hg
• Patients who have moderate neck pain and disability scoring 15 to 24 from 50 on neck disability index. .
• Pain intensity more than 3 and less than 7 on visual analogue scale (VAS)
• CVA less than 49°

You may not qualify if:

• People with severe neck pain. (Disability scoring more than 25 on Neck Disability Index)
• If they are participated in a neck rehabilitation program over the last 6 months
• Major circulatory or respiratory disorder
• Pregnant women or 3 months postnatal
• Patient with structural instability and degenerative conditions of cervical spine.
• Body Mass Index more than 30.
• Post traumatic or infective conditions.
• Any surgeries around cervical spine
• Vertigo patient
• Un-cooperative patient (Gupta et al., 2022).

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Eman Sherif, Doctoral

CONTACT

01016493234; doctoremo87@gmail.com

Salwa Abdel-mageed, Doctoral

CONTACT

01008565476

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain

Model Details: 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)

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share