Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Neck Pain Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eddy Siu Hon Kit, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier:
NCT01310595
First received: March 7, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Neck Pain
Procedure: Manual mobilization on cervical spine
Procedure: Infra-red therapy with self exercise pamphlet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Investigate the Effectiveness of Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Patients With Non-traumatic Chronic Mechanical Neck Pain.

Resource links provided by NLM:


Further study details as provided by The Hong Kong Polytechnic University:

Primary Outcome Measures:
  • Head repositioning accuracy [ Time Frame: up to 6 month post intervention ] [ Designated as safety issue: No ]
    Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.


Secondary Outcome Measures:
  • Postural balance [ Time Frame: up to 6 month post intervention ] [ Designated as safety issue: No ]
    Standing postural sway using computerized validated equipment.

  • Northwick Park Questionnaire [ Time Frame: up to 6 month post intervention ] [ Designated as safety issue: No ]
    Neck disability questionnaire

  • Active neck range of motion [ Time Frame: up to 6 month post intervention ] [ Designated as safety issue: No ]
    Active neck range of motion using 3-dimensional goniometer.

  • Numeric Pain Rating Scale [ Time Frame: up to 6 month post intervention ] [ Designated as safety issue: No ]
    Subjective numeric pain rating scale from 0 - 10.


Enrollment: 145
Study Start Date: January 2010
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual mobilization on cervical spine
Manual mobilization given on cervical spine with infra-red therapy and self exercise and advice pamphlet.
Procedure: Manual mobilization on cervical spine
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.
Procedure: Infra-red therapy with self exercise pamphlet
Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310595

Locations
Hong Kong
Physiotherapy Department, Prince of Wales Hospital
Stain, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Principal Investigator: Siu H Kit, MSc Hong Kong Polytechnic University
  More Information

No publications provided

Responsible Party: Eddy Siu Hon Kit, Physiotherapist, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT01310595     History of Changes
Other Study ID Numbers: HongKong PU
Study First Received: March 7, 2011
Last Updated: August 26, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by The Hong Kong Polytechnic University:
Musculoskeletal manipulations
Proprioception
Postural balance

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014