- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089021
Maitland Mobilization Versus Mulligan Mobilization in Sub-Acute and Chronic Non-Specific Neck Pain
This study investigate the short term effect of Maitland in comparison to Mulligan mobilization with sub-acute and chronic non specific neck pain to improve neck pain, pain pressure threshold, rang of motion, joint position sense, disability, and to evaluate the interaction with psychological factors.
Study design: experimental study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Jeddah, Saudi Arabia
- King AbdulAziz Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Patients aged between 20 to 50 years.
- Neck pain more than one week without radicular symptoms.
- Pain on posterior neck from superior nuchal line to first thoracic vertebra.
Exclusion Criteria:
• Patient contraindicate to mobilization (pregnancy, whiplash injury, tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis and resting blood pressure higher than 140/90 mmHg).
- Cervical radiculopathy.
- Fibromyalgia pain syndrome.
- Previous neck surgery.
- Neck pain associate with vertigo caused by vertebrobasilar insufficiency or chronic headache.
- Patient received physical therapy treatment in the previous three months.
- Psychiatric disorders.
- Vestibular system deficits.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mulligan mobilization
mobilization for spinous process or facet with neck movement 10 repetetions for 3 times.
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mobilization with movement for spinous process or facet joint.
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Experimental: maitland mobilization
maitland mobilization for spinous process or facet joint for 2 min and repeated 3 times.
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posterioanterior of spinous process or facet joint.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain pressure threshold
Time Frame: 3 weeks
|
It will be measured with an electronic algometer (Somedic AB, Farsta, Sweden) with a circular probe of 1 cm2.
The PPT will be measured over the following site: (1) area of maximum tenderness over the cervical spine as identify by palpation, (2) tibialis anterior muscle (upper one-third of the muscle belly) bilateral.
Tibialis anterior sites will be as remote lower limb sites to investigate any widespread changes in sensitivity.
The pressure will be applied perpendicular over the identified sites at a rate of 40 KPa/s until the individual verbally states that the pressure is starting to change to a pain sensation.
Then, the pressure will be stopped.
The test will be repeated three times for each site within 30 second between measurements.
An average of three measurements will be calculated
|
3 weeks
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pain intensity
Time Frame: 3 weeks
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: numeric pain rating scale (NPRS) will be used to evaluate the intensity of pain perceived by patient.
Pain is rated on 11 point scale from (0) no pain to (10) sever pain.
The patients will be asked to point out the number that describes their pain level.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cervical range of motion
Time Frame: 3 weeks
|
it will be measured by cervical range of motion (CROM) device.
It consists of three gravitational inclinometers system for flexion, extension and lateral flexion, and magnetic inclinometer for rotation.
|
3 weeks
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joint position sense
Time Frame: 3 weeks
|
it will be measured by using the (CROM) device
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3 weeks
|
neck disability index
Time Frame: 3 weeks
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This questioner is used to report disability results from neck pain and it is a self-report based outcome.
In addition, it contains ten sections with total score of 50 points
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3 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State trait anxiety inventory questionnaire (STAI-Y):
Time Frame: 3 weeks
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It has 20 items for assessing trait anxiety and 20 for state anxiety
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3 weeks
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Beck depression inventory questionnaire (BDI)
Time Frame: 3 weeks
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it contains 21 items; each item has four self evaluation statements in a time frame of two weeks, and scores from 0 to 3. The total score for 21 items range from 0 to 63
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3 weeks
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Fear avoidance believe questionnaire (FABQ)
Time Frame: 3 weeks
|
this questionnaire can assess the fear avoidance believe about the pain.
It consists of 16 items.
First five questions are related to fear avoidance of physical activities (FABQ- PA).
Then the eleven questions are related to avoidance of work (FABQ-W).
The score for each question is ranged from 0 (strong disagreement) to 6 (strong agreement).
The total score is ranged from 0 to 66. Higher score is represented high level of fear avoidance believe
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3 weeks
|
pain catestrophizing scale
Time Frame: 3 weeks
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3 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: samar alansari, master, Imam Abdulrahman Bin Faisal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- IRB -PGS-2016-03-143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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