NCT01310595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

3.5 years

First QC Date

March 7, 2011

Last Update Submit

August 26, 2013

Conditions

Neck Pain

Keywords

Musculoskeletal manipulationsProprioceptionPostural balance

Outcome Measures

Primary Outcomes (1)

  • Head repositioning accuracy

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

    up to 6 month post intervention

Secondary Outcomes (4)

  • Postural balance

    up to 6 month post intervention

  • Northwick Park Questionnaire

    up to 6 month post intervention

  • Active neck range of motion

    up to 6 month post intervention

  • Numeric Pain Rating Scale

    up to 6 month post intervention

Study Arms (2)

Manual mobilization on cervical spine

EXPERIMENTAL

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

Procedure: Manual mobilization on cervical spine

Infra-red radiation therapy

ACTIVE COMPARATOR

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

Procedure: Infra-red therapy with self exercise pamphlet

Interventions

Manual mobilization on cervical spinePROCEDURE

Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin

Manual mobilization on cervical spine
Infra-red therapy with self exercise pamphletPROCEDURE

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

Infra-red radiation therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Department, Prince of Wales Hospital

Stain, Hong Kong

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Siu H Kit, MSc

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

January 1, 2010

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

HK(1)