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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05838794
Other study ID # 012/004222
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2023
Est. completion date August 6, 2023

Study information

Verified date August 2023
Source Ahram Canadian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

PURPOSE: To compare the effects of mckenzie exercises plus stabilization exercise to those of mckenzie exercises alone on disability, pain, range of motion (ROM) in patients with nonspecific chronic neck pain (NSCNP). BACKGROUND: Little is known about the efficacy of providing mckenzie exercises in addition to cervical and scapulothoracic stabilization exercises in people with NSCNP. HYPOTHESES We hypothesize that there will be no significant effect of adding stabilization exercises to mckenzie exercises than mckenzie exercises alone in patients with NSCNP. RESEARCH QUESTION: Is there a statistically significant effect of adding stabilization exercises to mckenzie exercises on outcomes of patients with NSCNP?


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date August 6, 2023
Est. primary completion date August 6, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: 1. Ages between 30 and 50 years 2. Localized chronic neck pain without an exact etiology 3. Absence of any arm pain or discomfort that could be replicated by neck mobility or irritant assessment 4. Pain exists in the dorsal area, between two horizontal lines: the first line passes through 5) the lower half of the occipital area, and the second line runs through the spinous process of the first dorsal vertebra Exclusion Criteria: 1. Neck pain caused by any other complications, such as a neoplasm, neurological diseases, or vascular diseases 2. History of neck surgery or fracture 3. Serious medical conditions that could affect participation in the study, such as cardiovascular disease, cancer, or autoimmune disorders 4. Use of medication that could affect neck pain or exercise tolerance, such as opioids, muscle relaxants, or corticosteroids 5. Participation in other treatments or interventions for neck pain during the study period 6. Inability to understand or comply with study procedures or interventions, such as language barriers or cognitive impairment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mckenzie exercise for neck
The McKenzie protocol will be used to manage extension, rotation, and lateral flexion dysfunctions in patients with non-specific neck pain. An experienced physical therapist will perform the protocol 3 times a week for 6 weeks, tailoring exercises to each patient's individual needs based on limited and painful directions of movement. Exercises include retraction, extension, rotation, lateral flexion, and overpressure techniques. Patients will receive education on posture and body mechanics, and exercises will be progressed over time as the patient improves.
Stabilization exercise
Cervical and scapulothoracic stabilization exercises will be performed by an experienced physical therapist 3 times a week for 6 weeks, with each session including a warm-up, stabilization exercises, and cool-down and stretching exercises. Postural education will be provided using mirrors to find a neutral balanced position, and the cervical bracing technique with deep neck flexor activation will be used to stabilize the cervical spine. Upper extremity range of motion exercises and cervical dynamic isometric exercises with elastic resistive bands will also be performed. Scapulothoracic stabilization exercises will include specific exercises for muscles affecting scapular orientation related to neck pain, using latex bands with mild or medium tension.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity via Numeric pain rating scale The primary outcome measure will be pain intensity, assessed using the Numeric Pain Rating Scale (NPRS). The intervention will consist of a 4-week program of cervical and scapulothoracic stabilization exercises, performed 3 times a week under the supervision of an experienced physical therapist. Pain intensity will be measured at baseline and 6 weeks after the end of the treatment program. Changes in pain intensity at baseline and 6 weeks after end of treatment program.
Secondary Neck disability index The Neck Disability Index (NDI) is a standardized questionnaire that assesses the degree of disability related to neck pain. It consists of 10 questions that evaluate the impact of neck pain on daily activities, such as personal care, lifting, reading, driving, and sleeping. Each question is rated on a scale from 0 to 5, with a total score ranging from 0 to 50. Higher scores indicate greater disability related to neck pain. The NDI is a widely used and validated tool for measuring neck pain-related disability and has been shown to be responsive to changes in disability over time. It is a recommended outcome measure in clinical trials and practice guidelines for patients with neck pain. Changes in disability at baseline and 6 weeks after end of treatment program.
Secondary Cervical range of motion Cervical range of motion will be assessed with the patient sitting comfortably on a chair, with both feet flat on the floor, hips and knees at 90° of flexion, and buttocks positioned against the back of the chair. A cervical range-of-motion (CROM) device will be placed on the top of the head, and the patient will be asked to move the head as far as possible without pain in a standard fashion: flexion, extension, right lateral flexion, left lateral flexion, right rotation, and left rotation. Three trials will be conducted for each direction of movement, and the mean values of the 3 trials will be recorded for analysis. The reliability of the CROM device in previous studies indicates intraclass correlation coefficients ranging from 0.66 to 0.94, suggesting that it is a valid and reliable method for measuring cervical range of motion. Changes in cervical range of motion at baseline and 6 weeks after end of treatment program.
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