Clinical trial NCT01310595: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neck Pain
Keywords: Musculoskeletal manipulations
Proprioception
Postural balance
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Head repositioning accuracy
timeFrame: up to 6 month post intervention
Secondary outcomes:
measure: Postural balance
timeFrame: up to 6 month post intervention
measure: Northwick Park Questionnaire
timeFrame: up to 6 month post intervention
measure: Active neck range of motion
timeFrame: up to 6 month post intervention
measure: Numeric Pain Rating Scale
timeFrame: up to 6 month post intervention
Other outcomes:
Locations:
city: Stain
country: Hong Kong
facility: Physiotherapy Department, Prince of Wales Hospital
Study officials:
affiliation: Hong Kong Polytechnic University
name: Siu H Kit, MSc
role: PRINCIPAL_INVESTIGATOR
References: