Neck PainNCT05838794
McKenzie Exercises for Chronic Neck Pain: Stabilization vs. Non-Stabilization
A study testing Mckenzie exercise for neck and Stabilization exercise in people with Neck Pain and Cervical Pain, run by Ahram Canadian University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Neck Pain, Cervical Pain
- What is being tested?
- Mckenzie exercise for neck and Stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Apr 2023to 6 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: Effectiveness of McKenzie Exercises With and Without Stabilization Exercises in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Trial
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.
Read more
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?
- Conditions
- Neck Pain, Cervical Pain
- Being tested
- Mckenzie exercise for neck, Stabilization exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie exercise for neckOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mckenzie exercise for neck; Other: Stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes in pain intensity at baseline and 6 weeks after end of treatment program.
Secondary outcomes (2)
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.
Measured: Changes in disability at baseline and 6 weeks after end of treatment program.
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.
Measured: Changes in cervical range of motion at baseline and 6 weeks after end of treatment program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start21 Apr 2023
- Primary completion6 Aug 2023
- Study completion6 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study chair, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838794
- Sponsor's protocol ID
- 012/004222
- Status last verified
- Aug 2023
- First submitted
- 19 Apr 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of McKenzie Exercises With and Without Stabilization Exercises in Patients With Nonspecific Chronic Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05838794
- Acronym / sponsor ID
- 012/004222
- Conditions
- Neck Pain, Cervical Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mckenzie exercise for neck | Active comparator | Other: Mckenzie exercise for neckParticipants 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. |
| Mckenzie ex for neck + Stabilization exercise for | Experimental | Other: Mckenzie exercise for neck, Other: Stabilization exerciseParticipants 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mckenzie exercise for neckThe 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. | Other | Mckenzie ex for neck + Stabilization exercise for, Mckenzie exercise for neck |
| Stabilization exerciseCervical 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. | Other | Mckenzie ex for neck + Stabilization exercise for |
Primary outcome
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.
2 secondary outcomes
Neck disability index
Time frame: Changes in disability at baseline and 6 weeks after end of treatment program.
Cervical range of motion
Time frame: Changes in cervical range of motion at baseline and 6 weeks after end of treatment program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study chair
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie exercise for neck and Stabilization exercise in people with Neck Pain and Cervical Pain, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity via Numeric pain rating scale (time frame: Changes in pain intensity at baseline and 6 weeks after end of treatment program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.