- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496699
The Comparsion of MCkenzie and Mulligan Exercise in Patients With Non-Specific Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The McKenzie approach is an evaluative and therapeutic strategy in the practice of musculoskeletal physiotherapy to manage pain and restore the function of the cervical spine. This approach aims to control cervical disability when used in the early stages such as postural correction and increasing flexibility of adjacent musculotendinous structures. It aims to classify mechanically induced spinal pain into postural, dysfunctional and dysregulation syndromes to centralize and reduce spinal pain. Cervical self-treatment techniques used by McKenzie specialists have been shown to be effective for nonspecific neck pain. The purpose of evaluating patients with cervical-related disorders is to select self-management techniques as directional preference movements that should be repeated to reduce pain and symptoms. When we look at the studies in the literature; It has been reported that Mulligan concept techniques improve pain and disability symptoms in patients with chronic mechanical neck pain at the short- and medium-term effect level. In a study comparing Mulligan and McKenzie practices previously, it was concluded that Mulligan exercise was more effective in improving cervical range of motion than McKenzie exercise in adults with reduced cervical lordosis. In another comparative article, according to the results of the study comparing the two exercise techniques, it was seen that cervical ROM increased in both exercise groups.
However, it was concluded that the Mulligan exercise group showed better results than the Mckenzie group in the early period. Different types of mobilization are used to treat neck pain, but limited studies have been conducted to compare the effectiveness of two different mobilization techniques in the treatment of neck pain.
The aim of the study was that two different exercise programs (mckenzi-mulligan) were used in individuals with non-specific neck pain; to compare their effects on pain, range of motion (ROM) and functional outcomes. It is aimed to compare the effect of Mulligan exercises and Mckenzie exercises on pain reduction, joint range of motion, recovery speed, muscle activation and functional treatment in individuals with non-specific neck pain due to non-specific neck pain due to multifactorial etiology. Considering that there should be a larger number of studies on this subject with the literature review, it is aimed to contribute this study to the literature.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İstanbul, Turkey, 16360
- Istinye University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals with neck pain of unknown origin for more than 3 months
- Individuals between the ages of 18-45
- Non-smokers
- Individuals who have the ability to understand and apply Turkish written and verbal instructions
Exclusion Criteria:
- Individuals with a history of neck injury, micro or macro trauma,
- Individuals with tumors in and around the spinal cord,
- Individuals who have undergone surgery from the neck and shoulder region,
- Individuals with positive Vertebrobacillary Artery Test,
- Female individuals who are pregnant, individuals receiving hormone therapy,
- Individuals with neurological disease,
- Individuals with neuropathic pain due to neurological and systemic disorders,
- Patients with any loss of function in the upper extremities due to musculoskeletal disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: mckenzie group
Mckenzie exercise protocol will be applied to the participants in this group.
It will be applied to the participants for 4 weeks and 5 days a week for 30 minutes.
The exercise program will be performed by the patient under the supervision of a physiotherapist.
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Experimental: mullgian group
Mulligan exercise protocol will be applied to the participants in this group.
It will be applied to the participants for 4 weeks and 5 days a week for 30 minutes.
The exercise program will be performed by the patient under the supervision of a physiotherapist.
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The exercises to be applied are listed below. 1- C1-C2 Self Mobilization Slip is applied for natural apophyseal cervical right rotation. The belt is put on level C1. At the same time, the participant actively pulls the belt and turns his head to the right. To facilitate the rotation of the belt in C1, pressure is applied to the belt in the same direction as C2 and rotation of the head towards the restricted side is requested. It waits like this for 3 seconds. These movements are done in the painless range. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale
Time Frame: First week
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A visual analog scale will be used to assess participants' degree of neck pain before and after treatment.
It will be created by marking the instantaneous pain according to the levels on a scale with the visual analog scale.
The pain felt by the person will be marked as "0: no pain", "10: I feel very severe pain".
Scoring will be made from the parts marked on the plane over the points given by the person.
The validity and reliability study of the scale was done by Price et al. made by The scale was adapted to Turkish by A. Aydın et al.
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First week
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Neck Disability Index
Time Frame: First week
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In order to evaluate neck functionality, Vernon et al.
Developed by Turkish version study Aslan et al. made by The Neck Disability Questionnaire includes a total of 10 questions such as pain, personal care, concentration, working, driving, and sleeping.
Each question will be scored between 0-5 points.
The survey will be evaluated out of a maximum of 50 points.
0 points means no restrictions, 50 points means full apology.
0-4 points will be considered as no disability, 5-14 points as mild disability, 14-24 points as moderate disability, 25-34 points as severe disability and 35 and above as complete disability.
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First week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of Muscle Strength
Time Frame: First week
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A hand held dynamometer, which is a valid and reliable method, will be used to evaluate muscle strength.
(17) Neck muscle strength will be evaluated in four directions with extension, forward flexion, and right and left lateral flexion.
The position of the dynamometer will be adjusted at the occipital protuberance for extension, above the eyebrows for forward flexion, and above the corresponding ear for right lateral flexion and left lateral flexion.
The tests will be repeated three times and patients will be given a rest period of at least one minute between repetitions.
The highest value from the results obtained with these measurements will be recorded in Newton (N) as the maximum force to be used in statistical analysis.
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First week
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Tampa Kinesiophobia Scale
Time Frame: First week
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17-question survey will be conducted to assess participants' injury avoidance and fear of movement.
The scale is scored with Likert scoring (1 = I strongly disagree, 4 = I completely agree).
The total score is between 17-68, and it is understood that the higher the score the participant gets, the higher the kinesiophobia.
A total score of more than 37 is considered as a high degree of kinesiophobia.
(20)
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First week
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Fremantle Neck Awareness Questionnaire
Time Frame: First week
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Fremantle Neck Awareness Questionnaire will be applied to the participants in order to evaluate the relationship between kinesiophobia and neck awareness.
Likert type assessing individual-specific altered perception (0 = Never/Never feel this way, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time) It's a simple survey.
The questionnaire asks individuals 9 questions such as how they perceive their neck relative to their body, how they perceive their body position.
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First week
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Corbin Posture Analysis
Time Frame: First week
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Corbin Posture Analysis For posture assessment, Corbin et al.'s form was used, in which postural disorders were scored according to severity (0=absent, 1=mild, 2=moderate, 3=well-severe) by observing the case from the lateral and posterior.
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First week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burcu Pamukçu, Istinye University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IstinyeFTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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