- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310595
Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Neck Pain Patients
August 26, 2013 updated by: Eddy Siu Hon Kit, The Hong Kong Polytechnic University
To Investigate the Effectiveness of Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Patients With Non-traumatic Chronic Mechanical Neck Pain.
To investigate the effect of cervical manual mobilization on head repositioning accuracy and postural balance in patients with chronic mechanical neck pain in a randomized controlled trial.
Hypothesis: There is no difference between the intervention group (manual mobilization) and control group head repositioning accuracy and postural balance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to investigate the effectiveness of manual therapy to standing balance and head-neck proprioception sense in patients with chronic neck pain.
The study will recruit 120 chronic neck pain patients and randomize the into 2 groups of 60.
Group 1 will receive a course of manual therapy and infrared radiation for 15 minutes (twice weekly for 12 sessions).
The other group (control) will receive infrared radiation therapy only.
Manual therapy will be provided by experienced physiotherapists and assessed by a separate assessor.
All outcome measures will be assessed at the beginning of study, upon completion of intervention, 3-month and 6-month after the completion of study.
All measurements collected will be analysed by computerized statistical software in order to calculate the effectiveness of manual therapy and relationship among those outcome measurements.
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stain, Hong Kong
- Physiotherapy Department, Prince of Wales Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 to 65 years
- Presented with a complaint of neck pain (defined as pain in the region from the upper thoracic spine to the occiput and the surrounding musculature) for more than 7 weeks.
- Had not received neck pain treatment in the past 1 month
Exclusion Criteria:
- Onset of presenting neck pain episode after trauma (eg, whiplash)
- History of cervical injury of trauma since the onset of presenting neck pain episode
- History of cervical injury or trauma
- Neck pain due to fracture, tumor, infection, severe spondyloarthropathy, or other non-mechanical cause such as inflammatory arthritis;
- Progressive neurological deficit, myelopathy, herniated nucleus pulpous, or severe incapacitating pain;
- Being treated by electrical devices;
- Blood coagulation disorder or were using corticosteroids or anticoagulant medications;
- History of stroke or transient ischemic attacks;
- Vertebrobasilar artery insufficiency;
- Neurologic disease (eg, multiple sclerosis, Parkinson's disease, syringomyelia);
- Congenital anomalies involving the C-spine;
- Systemic disease (eg, diabetes mellitus);
- Pain involving third-party liability or Workers' Compensation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual mobilization on cervical spine
Manual mobilization given on cervical spine with infra-red therapy and self exercise and advice pamphlet.
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Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin
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Active Comparator: Infra-red radiation therapy
Infra-red radiation therapy with self exercise pamphlet given to patients with chronic mechanical neck pain.
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Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Head repositioning accuracy
Time Frame: up to 6 month post intervention
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Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.
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up to 6 month post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural balance
Time Frame: up to 6 month post intervention
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Standing postural sway using computerized validated equipment.
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up to 6 month post intervention
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Northwick Park Questionnaire
Time Frame: up to 6 month post intervention
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Neck disability questionnaire
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up to 6 month post intervention
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Active neck range of motion
Time Frame: up to 6 month post intervention
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Active neck range of motion using 3-dimensional goniometer.
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up to 6 month post intervention
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Numeric Pain Rating Scale
Time Frame: up to 6 month post intervention
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Subjective numeric pain rating scale from 0 - 10.
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up to 6 month post intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Siu H Kit, MSc, Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 7, 2011
First Submitted That Met QC Criteria
March 7, 2011
First Posted (Estimate)
March 8, 2011
Study Record Updates
Last Update Posted (Estimate)
August 28, 2013
Last Update Submitted That Met QC Criteria
August 26, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HongKong PU
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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