Neck PainNCT05496699
The Comparsion of MCkenzie and Mulligan Exercise in Patients With Non-Specific Neck Pain
A study testing Mckenzie Exercises and Mulligan Exercise in people with Neck Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Non-specific neck pain (NSBA) is defined as pain in the posterior and lateral parts of the neck in the absence of neurological and specific pathologies (fracture, infection, inflammation, etc.) between the superior nuchael line and the 1st thoracic vertebra. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mckenzie Exercises and Mulligan Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Jun 2022
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Non-specific neck pain (NSBA) is defined as pain in the posterior and lateral parts of the neck in the absence of neurological and specific pathologies (fracture, infection, inflammation, etc.) between the superior nuchael line and the 1st thoracic vertebra. The lifetime neck pain rate is approximately 12-70%; Neck pain is the reason for admission in approximately 25% of applications to outpatient clinics of the Physical Medicine and Rehabilitation Clinic. Neck pain is the most common spinal problem after low back pain, and it is defined as nonspecific neck pain due to its multifactorial etiology. Many conservative treatment methods are used in the treatment of NSBA. These include medical treatments, exercise, massage, acupuncture, neural therapy and physical therapy modalities. The basis of Mulligan's theory is based on a positional error that develops secondarily, causing misplacement of the joint. With the Mulligan mobilization technique, the joint is displaced to normal and positional error is corrected. Restoration of motion is aimed by repositioning the bone. The main indication in this technique is increased pain, stiffness and weakness in movement. The Mulligan mobilization technique is performed by asking for active movement while maintaining a manually applied joint shift. Painless movement is aimed at the joint. According to the general principles of Mulligan treatment, all techniques are applied in a way that does not cause pain and creates an effect that will eliminate the pain in a short time after the application.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Mckenzie Exercises, Mulligan Exercise
- Keywords
- neck pain, exercise, manuel therapy, physiotherapy
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie ExercisesBehavioural
- Cervical Retraction Exercise in Sitting Position The participant sits on the chair, puts the second and third fingers on his chin and pushes his head posteriorly and inferiorly.
- Cervical Rotation Exercise in Sitting Position
- Cervical Retraction Exercise in Supine Position
- Cervical Rotation Exercise in Supine Position The participant turns his head to the right and left, respectively, while taking his head back in the supine position with his head out of the bed.
- Cervical Lateral Flexion Exercise
- Cervical Flexion Exercise in Sitting Position
Mulligan ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mckenzie group | Experimental | 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. Receives: Behavioral: Mckenzie Exercises |
| mullgian group | Experimental | 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. Receives: Behavioral: Mulligan Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
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.
Measured: First week
Neck Disability Index
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.
Measured: First week
Secondary outcomes (4)
Evaluation of Muscle Strength
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.
Measured: First week
Tampa Kinesiophobia Scale
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)
Measured: First week
Fremantle Neck Awareness Questionnaire
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.
Measured: First week
Corbin Posture Analysis
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.
Measured: First week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Apr 2022
- Primary completion1 May 2022
- Study completion1 Jun 2022
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.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Model description
- 2 group, intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Çırak, Istinye University
- Investigators
- Burcu Pamukçu, Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496699
- Sponsor's protocol ID
- IstinyeFTR
- Status last verified
- Aug 2022
- First submitted
- 7 Feb 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparsion of MCkenzie and Mulligan Exercise in Patients With Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT05496699
- Acronym / sponsor ID
- IstinyeFTR
- Conditions
- Neck Pain
- Keywords
- neck pain, exercise, manuel therapy, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Aug 2022 (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.
Non-specific neck pain (NSBA) is defined as pain in the posterior and lateral parts of the neck in the absence of neurological and specific pathologies (fracture, infection, inflammation, etc.) between the superior nuchael line and the 1st thoracic vertebra. The lifetime neck pain rate is approximately 12-70%; Neck pain is the reason for admission in approximately 25% of applications to outpatient clinics of the Physical Medicine and Rehabilitation Clinic. Neck pain is the most common spinal problem after low back pain, and it is defined as nonspecific neck pain due to its multifactorial etiology. Many conservative treatment methods are used in the treatment of NSBA. These include medical treatments, exercise, massage, acupuncture, neural therapy and physical therapy modalities. The basis of Mulligan's theory is based on a positional error that develops secondarily, causing misplacement of the joint. With the Mulligan mobilization technique, the joint is displaced to normal and positional error is corrected. Restoration of motion is aimed by repositioning the bone. The main indication in this technique is increased pain, stiffness and weakness in movement. The Mulligan mobilization technique is performed by asking for active movement while maintaining a manually applied joint shift. Painless movement is aimed at the joint. According to the general principles of Mulligan treatment, all techniques are applied in a way that does not cause pain and creates an effect that will eliminate the pain in a short time after the application.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 group, intervention
| Arm | Type | Receives |
|---|---|---|
| mckenzie group | Experimental | Behavioral: Mckenzie ExercisesMckenzie 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. |
| mullgian group | Experimental | Behavioral: Mulligan ExerciseMulligan 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
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 Exercises1. Cervical Retraction Exercise in Sitting Position The participant sits on the chair, puts the second and third fingers on his chin and pushes his head posteriorly and inferiorly. 2. Cervical Rotation Exercise in Sitting Position 3. Cervical Retraction Exercise in Supine Position 4. Cervical Rotation Exercise in Supine Position The participant turns his head to the right and left, respectively, while taking his head back in the supine position with his head out of the bed. 5. Cervical Lateral Flexion Exercise 6. Cervical Flexion Exercise in Sitting Position | Behavioural | mckenzie group |
| Mulligan ExerciseThe 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. | Behavioural | mullgian group |
Primary outcome
Visual Analog Scale
Time frame: First week
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.
Neck Disability Index
Time frame: First week
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.
4 secondary outcomes
Evaluation of Muscle Strength
Time frame: First week
Tampa Kinesiophobia Scale
Time frame: First week
Fremantle Neck Awareness Questionnaire
Time frame: First week
Corbin Posture Analysis
Time frame: First week
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 11 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Burcu Pamukçu principal investigator
Istinye 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 Exercises and Mulligan Exercise in people with Neck Pain, run by Istinye University at 1 site in Turkey (Türkiye).
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 8 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 11 Aug 2022. 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 Turkey (Türkiye). 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?
Visual Analog Scale (time frame: First week). The study lists 2 primary outcomes in all. 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 11 Aug 2022.