NCT05838794

Brief 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

April 19, 2023

Last Update Submit

August 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Neck disability index

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

  • Cervical range of motion

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

Study Arms (2)

Mckenzie exercise for neck

ACTIVE COMPARATOR

Participants in the McKenzie exercise for neck group will receive a six-week exercise program that includes the McKenzie exercise protocol for neck pain. The program will consist of three 30-45 minute sessions per week, for a total of 18 sessions over six weeks. The exercises will be performed under the supervision of a physiotherapist in the outpatient clinic. The McKenzie exercise protocol for neck pain involves a series of movements that aim to reduce pain and improve range of motion in the cervical spine. The exercises are tailored to each participant's individual needs and may include sustained postures, repeated movements, and mobilization techniques. Participants will be instructed to perform the exercises at home as well, as part of a home exercise program, to ensure that they are performing the exercises correctly and consistently. Participants in this group will not receive any additional stabilization exercises.

Other: Mckenzie exercise for neck

Mckenzie ex for neck + Stabilization exercise for

EXPERIMENTAL

Participants in the McKenzie exercises for neck with cervical and scapulothoracic stabilization exercises group will receive a six-week exercise program that includes the McKenzie exercise protocol for neck pain and cervical and scapulothoracic stabilization exercises, performed under the supervision of a physiotherapist in the outpatient clinic. The program consists of three 30-45 minute sessions per week for a total of 18 sessions over six weeks. Participants will perform the McKenzie exercise protocol for neck pain first, followed by cervical and scapulothoracic stabilization exercises. Stabilization exercises aim to improve strength, endurance, and neuromuscular control of the cervical and scapulothoracic muscles. Participants will be instructed to perform the exercises at home as part of a home exercise program to ensure proper technique and consistency. This group receives both the McKenzie exercise protocol for neck pain and cervical and scapulothoracic stabilization exercises.

Other: Mckenzie exercise for neckOther: Stabilization exercise

Interventions

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.

Mckenzie ex for neck + Stabilization exercise forMckenzie exercise for neck

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.

Mckenzie ex for neck + Stabilization exercise for

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessors who will measure the outcomes will be blinded to the group allocation of participants. However, participants and the treating physiotherapist will not be blinded to the group allocation due to the nature of the intervention. Participants will be instructed not to reveal their group allocation to the assessor during the outcome assessment. To ensure blinding, the assessors will be instructed not to ask any questions that may reveal the group allocation of the participants. In addition, the assessors will be instructed not to discuss the study with the participants to avoid any potential unblinding.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 3, 2023

Study Start

April 21, 2023

Primary Completion

August 6, 2023

Study Completion

August 6, 2023

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

The individual participant data (IPD) collected during this study will be available upon reasonable request. Requests for access to the data should be submitted via email to mohamed.elmeligie@acu.edu.eg. All requests will be reviewed by the study investigators to ensure that they are reasonable and consistent with the ethical principles of the study. Access to the data will be granted in compliance with applicable laws and regulations, and with appropriate safeguards to protect the privacy and confidentiality of study participants.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
During the study and after 1 year of ending the trial
Access Criteria
via email to mohamed.elmeligie@acu.edu.eg

Locations