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

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

      • Stain, Hong Kong
        • Physiotherapy Department, Prince of Wales Hospital

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.
Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin
Active Comparator: Infra-red radiation therapy
Infra-red radiation therapy with self exercise pamphlet given to patients with chronic mechanical neck pain.
Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.

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
Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.
up to 6 month post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural balance
Time Frame: up to 6 month post intervention
Standing postural sway using computerized validated equipment.
up to 6 month post intervention
Northwick Park Questionnaire
Time Frame: up to 6 month post intervention
Neck disability questionnaire
up to 6 month post intervention
Active neck range of motion
Time Frame: up to 6 month post intervention
Active neck range of motion using 3-dimensional goniometer.
up to 6 month post intervention
Numeric Pain Rating Scale
Time Frame: up to 6 month post intervention
Subjective numeric pain rating scale from 0 - 10.
up to 6 month post intervention

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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