- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06858124
Mulligan vs Maitland With Home-Based Exercise for Non-Specific Neck Pain
Comparison of Mulligan and Maitland Mobilization Techniques Combined With Home-Based Exercise for Non-Specific Neck Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Non-specific neck pain (NSNP) is a prevalent musculoskeletal condition with multiple contributing factors. Various manual therapy approaches, such as Mulligan and Maitland mobilizations, are commonly applied to alleviate pain and enhance function.
Aim: The purpose of this clinical study is to investigate the short-term effects of Mulligan in comparison to Maitland mobilization techniques in conjunction with a home-based therapeutic exercise (TE) program.
Method: 43 participants with non-specific neck pain will be randomly assigned to three groups of 14, 14 and 15 participants each. In the participants of the first group, a therapeutic protocol of mulligan mobilizations will be applied to the cervical region. In addition, the participants will perform a home-based therapeutic exercise program. To the participants of the second group, a therapeutic protocol of maitland mobilizations will be applied to the cervical region and they will perform the same home-based exercise protocol with the first group. The third group participants will perform only the same home-based exercise protocol with the other groups. The first two groups will receive four mobilization treatments over two weeks. All three groups will perform the home-based exercise protocol daily for two weeks. Pain in the last 24 hours with the Numeric Pain Rating Scale (NPRS), Pressure Pain Threshold (PPT) in the cervical region with an algometer, functional ability with the Neck Disability Index (NDI), Range of Motion (ROM) with a digital goniometer, pain catastrophizing with the Pain Catastrophizing Scale (PCS) and kinesiophobia with the Tampa Scale of Kinesiophobia (TSK) will be evaluated before and after the intervention. For the statistical analysis of the results, a two-way repeated measures analysis of variance (ANOVA) will be applied using SPSS program, while the statistical significance index will be set at p < .05. Expected results: The protocol proposed in this clinical study combines the benefits of applying manual therapy mobilizations with the beneficial effects of therapeutic exercise. Previous research shows Mulligan mobilizations may be slightly more beneficial in improving patients' symptoms with non-specific neck pain. For this reason, we expect that the combination of Mulligan mobilizations and home-based therapeutic exercise will be more effective than the combination of Maitland mobilizations and home-based therapeutic exercise only in improving the clinical symptoms of young adults with non-specific neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Thessaloniki, Greece, 57400
- International Hellenic University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Acute-subacute-chronic neck pain
- Women - Men
- Age range between 18 and 30 years
- NPRS score >2
- Written consent to participate in the study
Exclusion Criteria:
• Previous cervical/thoracic surgery
- Recent whiplash (≤6 months)
- Upper cervical pathology
- Osteoporosis
- Pregnancy
- Cancer
- Systemic diseases or spinal disorders
- Neurological symptoms
- Severe medical conditions, positive red flags (Spurling test, Hoffmann's sign, Babinski reflex, clonus)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mulligan+TE
Participants allocated to this group will receive four sessions of Mulligan mobilizations and will perform a home-based therapeutic exercise program for two weeks.
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Mulligan Mobilizations plus Home Therapeutic Exercise The protocol will last 25 minutes (Mulligan protocol: 5 minutes and Home Therapeutic Exercise protocol: 20 minutes) and will include the application of the following mulligan techniques and home exercises:
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Experimental: Maitland +TE
Participants allocated to this group will receive four sessions of Maitland mobilizations and will perform a home-based therapeutic exercise program for two weeks.
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The participants of this group will perform the same 4 home-based therapeutic exercises as the first group. In addition, they will receive a 5-minute maitland mobilization protocol. Maitland mobilizations will include posterioranterior glides with oscillations with the patients in prone position. |
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Active Comparator: Active Comparator: "TE group".
Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group.
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Participants in this group will only perform the same 4 home-based therapeutic exercises as the first group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Pressure Pain Threshold (PPT) with pressure algometry
Time Frame: pre-treatment, week: 2
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Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain.
PPT will be assessed by a digital algometer and will be evaluated bilaterally in the upper trapezius muscle, between C7 and the acromion.
The rubber tip of the algometer will be placed vertically on the site and the examiner will apply gradually increasing pressure in a rate of 1Kg/s.
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pre-treatment, week: 2
|
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Changes in cervical range of motion with digital goniometry
Time Frame: pre-treatment, week: 2
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The cervical ROM of cervical flexion, extension, side bends and rotations will be assessed using a digital goniometer with the patient in the seated position.
Each movement will be carried out once within the maximum pain-free range and will be documented by an independent physiotherapist
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pre-treatment, week: 2
|
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Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
Time Frame: pre-treatment, week: 2
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This tool is an 11-point scale from 0 ("no pain") to 10 ("worst imaginable pain").
Consequently, a higher value indicates more intense pain.
The participant selects a number that best represents their pain intensity.
The NPRS is a well-validated tool commonly used to measure pain intensity in clinical practice and research.
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pre-treatment, week: 2
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Changes in functional ability with Neck Disability Index (NDI)
Time Frame: pre-treatment, week: 2]
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The Neck Disability Index (NDI), validated for the Greek population, will be used to assess disability.
It comprises 10 sections that evaluate pain intensity, functional restrictions, and daily activities, with a total score ranging from 0 (no disability) to 50 (severe disability).
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pre-treatment, week: 2]
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Changes in pain catastrophizing with Pain Catastrophizing Scale (PCS
Time Frame: pre-treatment, week: 2]
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The Pain Catastrophizing Scale (PCS) will be used to assess pain catastrophizing.
It is a 13-item questionnaire designed to assess catastrophic thinking related to pain.
Scores range from 0 to 52, with higher scores reflecting greater levels of catastrophizing across the subscales of rumination, magnification, and helplessness.
The Greek version demonstrates high reliability (ICC = 0.85, Cronbach's α = 0.80).
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pre-treatment, week: 2]
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Changes in kinesiophobia with Tampa Scale of Kinesiophobia (TSK)
Time Frame: pre-treatment, week: 2
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Kinesiophobia will be evaluated using the Tampa Scale of Kinesiophobia (TSK), a 17-item questionnaire that assesses fear of movement and anxiety related to injury.
Scores range from 17 to 68, with ≤37 indicating low kinesiophobia and >37 representing high kinesiophobia.
The Greek version has demonstrated good reliability (Cronbach's α = 0.74, ICC = 0.78).
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pre-treatment, week: 2
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Collaborators and Investigators
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
- EC-5/2025
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
product manufactured in and exported from the U.S.
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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