Chronic Neck PainNCT04643028
Effectiveness of Mulligan Mobilization Technique And Cervical Stabilization Training in Patients With Chronic Neck Pain
A study testing Home exercise, Mulligan mobilization and Cervical stabilization in people with Chronic Neck Pain, run by Serbay SEKEROZ.
Trial summary
The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Home exercise, Mulligan mobilization and Cervical stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having neck pain lasting more than 3 months
- Expressing neck pain at least 3,5/10 points and above on a Visual Analog Scale
- Being 18-65 years old
- Agree to participate in the study
- Having obtained 5/50 points and above in Neck Disability Index
Who cannot join
- Having had spinal surgery
- Other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis.
- Having a diagnosed psychiatric illness
- Having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year.
- The presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease.
- Any health problem that may prevent the application of evaluations and / or treatment other than those mentioned above.
- Difficulty in communication at a level that prevents the application of evaluations and / or treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Effectiveness of Mulligan Mobilization Technique and Cervical Stabilization Training in Patients With Chronic Neck Pain: A Single-Blinded Randomized Controlled Trial
The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.
Read the detailed description
The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.
The hypotheses we will test for this purpose; H1. Home exercise program will improve positively after treatment in patients with chronic neck pain compared to before treatment.
H2. Mulligan mobilization will improve positively after treatment in patients with chronic neck pain compared to before treatment.
H3. Cervical stabilization training will improve positively after treatment in patients with chronic neck pain compared to before treatment.
H4. Mulligan mobilization will provide more effective results in patients with chronic neck pain compared to other applications.
- Conditions
- Chronic Neck Pain
- Being tested
- Home exercise, Mulligan mobilization, Cervical stabilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home exerciseOther
Exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.
Mulligan mobilizationOther
Mulligan mobilization: Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions.Sixty seconds of rest will be given between sets.
Cervical stabilizationOther
Cervical stabilization group: In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise | Other | The exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises. Receives: Other: Home exercise |
| Mulligan mobilization | Other | Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions. Sixty seconds of rest will be given between sets. Receives: Other: Mulligan mobilization |
| Cervical stabilization | Other | In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles. Receives: Other: Cervical stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-10 cm, where 0 is the lowest pain and 10 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in cm.
Measured: 5 minutes
Neck Disability
Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability.
Measured: 5 minutes
Cervical Range of Motion
Cervical Range of Motion will be assessed by Baseline Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.
Measured: 5 minutes
Head Posture
Head posture will be evaluated using the craniovertebral angle. The decrease in the craniovertebral angle indicates an increased anterior head posture.
Measured: 5 minutes
Proprioception
The "joint position sense error test" defined by Revel et al. Will be used to evaluate cervical proprioception.
Measured: 5 minutes
Muscle Endurance
"Cervical Deep Flexor Muscle Endurance Test" will be used.
Measured: 3 minutes
Neck Awareness
The Fremantle Neck Awareness Questionnaire, which consists of few and short questions, does not take time, is easy to access, evaluates neck perception, attention and proprioceptive awareness, will be used. An increase in the score obtained from the questionnaire indicates a decrease in neck awareness.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serbay SEKEROZ
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Serbay SEKEROZ, Pamukkale University
- Investigators
- Emine Aslan Telci, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643028
- Sponsor's protocol ID
- 60116787-020/53905
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2020
- Last updated
- 24 Nov 2020
- 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 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Mulligan Mobilization Technique and Cervical Stabilization Training in Patients With Chronic Neck Pain: A Single-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04643028
- Acronym / sponsor ID
- 60116787-020/53905
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Serbay SEKEROZUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 24 Nov 2020 (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.
The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.
Detailed description
The aim of our study is to compare the efficiency of Mulligan mobilization technique and cervical stabilization training in patients with chronic neck pain. The results obtained from the study will contribute to the planning of the treatment of patients with chronic neck pain more effectively.
The hypotheses we will test for this purpose; H1. Home exercise program will improve positively after treatment in patients with chronic neck pain compared to before treatment.
H2. Mulligan mobilization will improve positively after treatment in patients with chronic neck pain compared to before treatment.
H3. Cervical stabilization training will improve positively after treatment in patients with chronic neck pain compared to before treatment.
H4. Mulligan mobilization will provide more effective results in patients with chronic neck pain compared to other applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home exercise | Other | Other: Home exerciseThe exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises. |
| Mulligan mobilization | Other | Other: Mulligan mobilizationMulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions. Sixty seconds of rest will be given between sets. |
| Cervical stabilization | Other | Other: Cervical stabilizationIn addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having neck pain lasting more than 3 months
- Expressing neck pain at least 3,5/10 points and above on a Visual Analog Scale
- Being 18-65 years old
- Agree to participate in the study
- Having obtained 5/50 points and above in Neck Disability Index
Key exclusion criteria (7 listed)
- Having had spinal surgery
- Other musculoskeletal problems that may affect the cervical region such as impingement, thoracic outlet and scoliosis.
- Having a diagnosed psychiatric illness
- Having benefited from physiotherapy and / or another treatment method due to spinal pain problem in the last 1 year.
- The presence of specific pathological conditions such as malignant condition, fracture, systemic rheumatoid disease.
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 |
|---|---|---|
| Home exerciseExercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises. | Other | Home exercise |
| Mulligan mobilizationMulligan mobilization: Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions.Sixty seconds of rest will be given between sets. | Other | Mulligan mobilization |
| Cervical stabilizationCervical stabilization group: In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles. | Other | Cervical stabilization |
Primary outcome
Pain Intensity
Time frame: 5 minutes
Pain intensity will be evaluated with the Visual Analogue Scale. The Visual Analogue Scale is a horizontal scale in the range of 0-10 cm, where 0 is the lowest pain and 10 the highest pain. The patient will be asked to mark the pain felt in the neck area on this line and the point marked will be measured with a ruler and recorded in cm.
Neck Disability
Time frame: 5 minutes
Neck Disability will be measured by Neck Disability Index. The Neck Disability Index is a frequently used scale to evaluate the level of disability due to neck pain. It consists of 10 items and 6 options under each item. Options are scored between 0-5 points. An increasing score indicates a higher level of disability.
Cervical Range of Motion
Time frame: 5 minutes
Cervical Range of Motion will be assessed by Baseline Bubble Inclinometer as degree of flexion-extension, rotation and lateral flexion and will be recorded.
Head Posture
Time frame: 5 minutes
Head posture will be evaluated using the craniovertebral angle. The decrease in the craniovertebral angle indicates an increased anterior head posture.
Proprioception
Time frame: 5 minutes
The "joint position sense error test" defined by Revel et al. Will be used to evaluate cervical proprioception.
Muscle Endurance
Time frame: 3 minutes
"Cervical Deep Flexor Muscle Endurance Test" will be used.
Neck Awareness
Time frame: 5 minutes
The Fremantle Neck Awareness Questionnaire, which consists of few and short questions, does not take time, is easy to access, evaluates neck perception, attention and proprioceptive awareness, will be used. An increase in the score obtained from the questionnaire indicates a decrease in neck awareness.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
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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.
Emine Aslan Telci, Professor study director
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Home exercise, Mulligan mobilization and Cervical stabilization in people with Chronic Neck Pain, run by Serbay SEKEROZ.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serbay Şekeröz, MSc (+905453009060, serbaysekeroz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 5 minutes). The study lists 7 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 24 Nov 2020.