Clinical trial NCT06107270: Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain
Official title: Effect of Deep Neck Flexors Biofeedback Training and Post Isometric Relaxation in Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deep Neck Flexors Training
Post Isometric Relaxation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: pain severity
timeFrame: 4 weeks
measure: functional disability
timeFrame: 4 weeks
measure: Deep Neck Flexors muscle endurance
timeFrame: 4 weeks
Secondary outcomes:
measure: craniovertebral angle (CVA)
timeFrame: 4 weeks
measure: cervical range of motion
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: