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

Neck Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310595
• Other study ID #: HongKong PU
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2011
• Last updated: August 26, 2013
• Start date: January 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• Manual mobilization on cervical spine
Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin
• 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.

Locations

Country	Name	City	State
Hong Kong	Physiotherapy Department, Prince of Wales Hospital	Stain

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Head repositioning accuracy	Head re-positioning accuracy by using laser-pointer mounted in a cyclist helmet.	up to 6 month post intervention	No
Secondary	Postural balance	Standing postural sway using computerized validated equipment.	up to 6 month post intervention	No
Secondary	Northwick Park Questionnaire	Neck disability questionnaire	up to 6 month post intervention	No
Secondary	Active neck range of motion	Active neck range of motion using 3-dimensional goniometer.	up to 6 month post intervention	No
Secondary	Numeric Pain Rating Scale	Subjective numeric pain rating scale from 0 - 10.	up to 6 month post intervention	No