Neck PainNCT06396104
Mobilization With Movement Technique on the Stiffness of Cervical Muscles in Individuals With Mechanical Neck Pain
A study testing Mobilisation with movement in people with Neck Pain, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
Mobilisation with movement (Mulligan Sustained Natural Apophyseal Glides (SNAG)). method has been shown to have significant effects on pain, joint range of motion, and functionality in patients with neck pain. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mobilisation with movement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 30 Jun 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having widespread neck pain lasting more than 3 months
- Pain symptoms that increase with neck movements or palpation
- Volunteering to participate in the study
Who cannot join
- History of neck trauma
- Previous cervical surgery
- Cervical radiculopathy or myelopathy
- Fibromyalgia syndrome diagnosis
- Any physiotherapy intervention in the previous 12 months
- Sign of vertebrobasilar insufficiency
- Upper cervical spine ligament instability
- Those using steroids or muscle relaxants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobilization With Movement Technique on the Stiffness of Cervical Muscles in Individuals With Mechanical Neck Pain: A Randomized Controlled Trial
Mobilisation with movement (Mulligan Sustained Natural Apophyseal Glides (SNAG)). method has been shown to have significant effects on pain, joint range of motion, and functionality in patients with neck pain. However, there is a lack of studies examining the effects of this technique on muscle stiffness associated with neck pain. Considering the immediate effects of a single session of lumbar SNAG application on lumbar muscle stiffness in patients with low back pain, it raises curiosity about the effects it would have on cervical spinal segments and surrounding muscles. The aim of this study is to investigate the immediate effects of Mulligan SNAG application on muscle stiffness, pain, and joint range of motion in patients with mechanical neck pain.
Read the detailed description
This study is designed as a parallel double-blind randomized controlled trial. Patients will be divided into two groups: the Mobilization with Movement Group (MMG) and the Sham Group (SG). The MMG will receive cervical mobilization (SNAG) treatment. The SG, on the other hand, will receive active joint movements without the 'sliding' motion applied to the spinal segment. Prior to and immediately after the intervention, participants will undergo myometric evaluation of neck muscles, joint range of motion measurements, and pressure pain threshold measurements bilaterally, followed by assessment of the individual's pain and level of disability using questionnaires related to pain and pain-associated disability. A 2-minute break will be provided after the intervention before reassessment is conducted. Patients will not be followed up.
- Conditions
- Neck Pain
- Being tested
- Mobilisation with movement, Sham mobilisation
- Keywords
- Neck Pain, Manual Therapy, Sham Treatment
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilisation with movementOther
The physiotherapist places the medial edge of the thumb of one hand on the upper facet joint of the relevant segment, then applies superior-anterior slide to the facet joint by providing support with the thumb of the other hand. The 'gliding' movement is maintained while the patient actively performs the unilateral neck rotation movement and maintains it for a few seconds at the end of the movement. If joint movement is painful, attempts are made on the other facet joint of the same segment or on the spinous process. If this attempt does not immediately improve the patient's active joint motion, Mulligan Sustained Natural Apophyseal Glides (SNAG) will be applied to the upper part of the left zygapophysial joint, and in case of failure again, application will be made through the superior spinous process of the relevant segment. Painless joint movement will be applied in 6 repetitions and 3 sets.
Sham mobilisationOther
While the patients are sitting in a chair with a supported back, the spinal segment where pain is felt in neck joint movements will be determined. Without applying a sliding movement to this segment over the facet joint, only sensory input will be given and the patient will be asked to continue the active rotation movement and wait a few seconds at the end of the movement. The application will be completed as 6 repetitions and 3 sets.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization with movement group | Experimental | Not described Receives: Other: Mobilisation with movement |
| Sham group | Sham comparator | Not described Receives: Other: Sham mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle stiffness
Muscle stiffness will be measured with MyotonPRO (Myoton SA, Tallinn, Estonia). A brief mechanical pulse is applied to the skin over the muscle and then quickly released. Stiffness (N/m) is a parameter related to the capacity to withstand an external force. The reliability of the device has been proven in healthy individuals.The measurement site will be marked on the skin with a pen. In all applications, MyotonPRO's probe will be placed perpendicular to the skin and 3 measurements will be recorded using the multi-scanning mode with 10 pulses 1 second apart, and the average of the 3 measurements will be used for analysis.
Upper trapezius: Evaluation will be performed in prone position. Measurements are from the midpoint between the lateral edge of the acromion and the spinous process of C7.
Sternocleidomastoid: Measurements will be made at the midpoint between the sternum and the mastoid protrusion, with individuals lying in a supine position with a soft pillow under the neck.
Measured: Baseline and immediately after application.
Secondary outcomes (3)
Joint Range of Motion
An dual digital inclinometer (ACUMAR Model 002; Lafayette Instrument Company, Lafayette, Indiana) will be used to measure cervical rotation. The device consists of two simple digital inclinometers connected to each other with the help of cables. Measured joint range of motions are displayed on the screen on the digital inclinometer.
Measured: Baseline and immediately after application.
Numeric Pain Rating Scale
Pain intensity of patients with neck pain will be obtained with the Numerical Rating Scale, which is reported to be a reliable and valid scale in determining pain intensity in the literature. In the scale, 0 indicates no pain and 100 indicates unbearable pain.
Measured: Baseline and immediately after application.
Neck Disability Index
Neck Disability Index (NDI) was used to evaluate the level of disability due to neck pain, which is a reliable and valid scale to determine the disability level of patients with chronic mechanical neck pain. NDI consists of 10 sections: pain intensity, personal care, weight lifting, reading, headaches, concentration, working, driving, sleep, and recreation. The score in each section varies between 0 (no disability) and 5 (complete disability). The total score ranges from 0 (no disability) to 50 (complete disability).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start10 Jan 2024
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
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
- Model description
- A Parallel, double blind, randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Kent University, Istanbul University - Cerrahpasa, Istanbul Demiroglu Bilim University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396104
- Sponsor's protocol ID
- IUC001
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization With Movement Technique on the Stiffness of Cervical Muscles in Individuals With Mechanical Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06396104
- Acronym / sponsor ID
- IUC001
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Manual Therapy, Sham Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Collaborators
- Istanbul Kent University, Istanbul University - Cerrahpasa, Istanbul Demiroglu Bilim University
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 May 2024 (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.
Mobilisation with movement (Mulligan Sustained Natural Apophyseal Glides (SNAG)). method has been shown to have significant effects on pain, joint range of motion, and functionality in patients with neck pain. However, there is a lack of studies examining the effects of this technique on muscle stiffness associated with neck pain. Considering the immediate effects of a single session of lumbar SNAG application on lumbar muscle stiffness in patients with low back pain, it raises curiosity about the effects it would have on cervical spinal segments and surrounding muscles. The aim of this study is to investigate the immediate effects of Mulligan SNAG application on muscle stiffness, pain, and joint range of motion in patients with mechanical neck pain.
Detailed description
This study is designed as a parallel double-blind randomized controlled trial. Patients will be divided into two groups: the Mobilization with Movement Group (MMG) and the Sham Group (SG). The MMG will receive cervical mobilization (SNAG) treatment. The SG, on the other hand, will receive active joint movements without the 'sliding' motion applied to the spinal segment. Prior to and immediately after the intervention, participants will undergo myometric evaluation of neck muscles, joint range of motion measurements, and pressure pain threshold measurements bilaterally, followed by assessment of the individual's pain and level of disability using questionnaires related to pain and pain-associated disability. A 2-minute break will be provided after the intervention before reassessment is conducted. Patients will not be followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Parallel, double blind, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mobilization with movement group | Experimental | Other: Mobilisation with movement |
| Sham group | Sham comparator | Other: Sham mobilisation |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having widespread neck pain lasting more than 3 months
- Pain symptoms that increase with neck movements or palpation
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- History of neck trauma
- Previous cervical surgery
- Cervical radiculopathy or myelopathy
- Fibromyalgia syndrome diagnosis
- Any physiotherapy intervention in the previous 12 months
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 |
|---|---|---|
| Mobilisation with movementThe physiotherapist places the medial edge of the thumb of one hand on the upper facet joint of the relevant segment, then applies superior-anterior slide to the facet joint by providing support with the thumb of the other hand. The 'gliding' movement is maintained while the patient actively performs the unilateral neck rotation movement and maintains it for a few seconds at the end of the movement. If joint movement is painful, attempts are made on the other facet joint of the same segment or on the spinous process. If this attempt does not immediately improve the patient's active joint motion, Mulligan Sustained Natural Apophyseal Glides (SNAG) will be applied to the upper part of the left zygapophysial joint, and in case of failure again, application will be made through the superior spinous process of the relevant segment. Painless joint movement will be applied in 6 repetitions and 3 sets. | Other | Mobilization with movement group |
| Sham mobilisationWhile the patients are sitting in a chair with a supported back, the spinal segment where pain is felt in neck joint movements will be determined. Without applying a sliding movement to this segment over the facet joint, only sensory input will be given and the patient will be asked to continue the active rotation movement and wait a few seconds at the end of the movement. The application will be completed as 6 repetitions and 3 sets. | Other | Sham group |
Primary outcome
Muscle stiffness
Time frame: Baseline and immediately after application.
Muscle stiffness will be measured with MyotonPRO (Myoton SA, Tallinn, Estonia). A brief mechanical pulse is applied to the skin over the muscle and then quickly released. Stiffness (N/m) is a parameter related to the capacity to withstand an external force. The reliability of the device has been proven in healthy individuals.The measurement site will be marked on the skin with a pen. In all applications, MyotonPRO's probe will be placed perpendicular to the skin and 3 measurements will be recorded using the multi-scanning mode with 10 pulses 1 second apart, and the average of the 3 measurements will be used for analysis. Upper trapezius: Evaluation will be performed in prone position. Measurements are from the midpoint between the lateral edge of the acromion and the spinous process of C7. Sternocleidomastoid: Measurements will be made at the midpoint between the sternum and the mastoid protrusion, with individuals lying in a supine position with a soft pillow under the neck.
3 secondary outcomes
Joint Range of Motion
Time frame: Baseline and immediately after application.
Numeric Pain Rating Scale
Time frame: Baseline and immediately after application.
Neck Disability Index
Time frame: Baseline
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 8 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilisation with movement in people with Neck Pain, run by Istanbul Gelisim 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 3 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 8 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Muscle stiffness (time frame: Baseline and immediately after application.). 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 8 Jul 2024.