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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Neck Flexors Training; Post Isometric Relaxation
• Intervention / Treatment: Device: infra red radiation; Other: post isometric relaxation; Device: pressure biofeedback; Device: therapeutic ultra sound

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman Sherif, Doctoral; Phone Number: 01016493234; Email: doctoremo87@gmail.com
• Study Contact Backup: Name: Salwa Abdel-mageed, Doctoral; Phone Number: 01008565476

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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: infra red radiation; (R 125, 250watt, Philips); Other: post isometric relaxation; sustained contraction followed by relaxation; Device: therapeutic ultra sound; continuous US waves of 1 MHz frequency and 1-1.5 W/cm2 power
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: infra red radiation; (R 125, 250watt, Philips); 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
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: infra red radiation; (R 125, 250watt, Philips); Other: post isometric relaxation; sustained contraction followed by relaxation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
craniovertebral angle (CVA)	Kinovea (version 0.9.5) will be used to calculate the CVA	4 weeks
cervical range of motion	Universal goniometer.to measure the active cervical range of motion in all directions.	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: DNFT+PIR technique

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No