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Completed

NCT Number: NCT05838794

McKenzie Exercises for Chronic Neck Pain: Stabilization vs. Non-Stabilization

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?

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Key information

Conditions

Neck Pain Cervical Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages between 30 and 50 years
  • Localized chronic neck pain without an exact etiology
  • Absence of any arm pain or discomfort that could be replicated by neck mobility or irritant assessment
  • 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

  • Neck pain caused by any other complications, such as a neoplasm, neurological diseases, or vascular diseases
  • History of neck surgery or fracture
  • Serious medical conditions that could affect participation in the study, such as cardiovascular disease, cancer, or autoimmune disorders
  • Use of medication that could affect neck pain or exercise tolerance, such as opioids, muscle relaxants, or corticosteroids
  • Participation in other treatments or interventions for neck pain during the study period
  • Inability to understand or comply with study procedures or interventions, such as language barriers or cognitive impairment

Treatment and study plan

Mckenzie exercise for neck

Other

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

Other

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.

Primary outcomes

  1. Pain intensity via Numeric pain rating scale

    Time frame: Changes in pain intensity at baseline and 6 weeks after end of treatment program.

    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.

Secondary outcomes

  1. Neck disability index

    Time frame: Changes in disability at baseline and 6 weeks after end of treatment program.

    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.

  2. Cervical range of motion

    Time frame: Changes in cervical range of motion at baseline and 6 weeks after end of treatment program.

    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.

Sponsors and collaborators

Lead sponsor

Ahram Canadian University

Other

Registry information

Official study title

Effectiveness of McKenzie Exercises With and Without Stabilization Exercises in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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