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

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Manual mobilization on cervical spine
Infra-red therapy with self exercise pamphlet
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Musculoskeletal manipulations, Proprioception, Postural balance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physiotherapy Department, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual mobilization on cervical spine

Infra-red radiation therapy

Arm Description

Manual mobilization given on cervical spine with infra-red therapy and self exercise and advice pamphlet.

Infra-red radiation therapy with self exercise pamphlet given to patients with chronic mechanical neck pain.

Outcomes

Primary Outcome Measures

Head repositioning accuracy
Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.

Secondary Outcome Measures

Postural balance
Standing postural sway using computerized validated equipment.
Northwick Park Questionnaire
Neck disability questionnaire
Active neck range of motion
Active neck range of motion using 3-dimensional goniometer.
Numeric Pain Rating Scale
Subjective numeric pain rating scale from 0 - 10.

Full Information

First Posted
March 7, 2011
Last Updated
August 26, 2013
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT01310595
Brief Title
Manual Therapy on Head-repositioning Accuracy and Static Postural Balance in Neck Pain Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Musculoskeletal manipulations, Proprioception, Postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual mobilization on cervical spine
Arm Type
Experimental
Arm Description
Manual mobilization given on cervical spine with infra-red therapy and self exercise and advice pamphlet.
Arm Title
Infra-red radiation therapy
Arm Type
Active Comparator
Arm Description
Infra-red radiation therapy with self exercise pamphlet given to patients with chronic mechanical neck pain.
Intervention Type
Procedure
Intervention Name(s)
Manual mobilization on cervical spine
Intervention Description
Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin
Intervention Type
Procedure
Intervention Name(s)
Infra-red therapy with self exercise pamphlet
Intervention Description
Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.
Primary Outcome Measure Information:
Title
Head repositioning accuracy
Description
Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.
Time Frame
up to 6 month post intervention
Secondary Outcome Measure Information:
Title
Postural balance
Description
Standing postural sway using computerized validated equipment.
Time Frame
up to 6 month post intervention
Title
Northwick Park Questionnaire
Description
Neck disability questionnaire
Time Frame
up to 6 month post intervention
Title
Active neck range of motion
Description
Active neck range of motion using 3-dimensional goniometer.
Time Frame
up to 6 month post intervention
Title
Numeric Pain Rating Scale
Description
Subjective numeric pain rating scale from 0 - 10.
Time Frame
up to 6 month post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siu H Kit, MSc
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiotherapy Department, Prince of Wales Hospital
City
Stain
Country
Hong Kong

12. IPD Sharing Statement

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

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