Electroacupuncture for Chronic Neck Pain - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	January 21, 2009
Last Updated Date	January 21, 2009
Start Date ^†	March 2007
Current Primary Outcome Measures ^† (submitted: January 21, 2009)	Change in neck pain specific disability index as measured by the Northwick Park Neck Pain Questionnaire (NPQ). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^†	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^† (submitted: January 21, 2009)	i) Change in maximum pain related to motion, regardless the direction of movement. ii) Quality of life as assessed by SF-36 health survey. iii) Use of medication because of neck pain iv) Sick leave because of neck pain. [ Time Frame: 6 months ] [ Designated as safety issue: No ] Adverse effects. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	Electroacupuncture for Chronic Neck Pain
Official Title ^†	A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain
Brief Summary	Objective: The primary objective of this study is to evaluate the long-term efficacy of electroacupuncture for chronic neck pain. The secondary objective is to document any possible side effects of acupuncture. Design and Subjects: Prospective, randomised controlled trial comparing the outcomes of treatment and placebo interventions. Subjects are 200 adult patients with chronic mechanical neck pain. Setting: Outpatient clinics. Interventions: Patients will be randomly allocated to one of the two groups receiving either: electroacupuncture (real treatment) or placebo (sham laser acupuncture). Each treatment will last for 45 minutes. Each patient will receive a total of nine treatments (three times per week for three weeks). Main outcome measures: Primary outcome measures: Neck pain disability index (Northwick Park Neck Pain Questionnaire). Secondary outcome measures: Maximum pain related to motion on visual analogue scale. Quality of life (SF-36). Use of medication. Sick leave because of neck pain. Treatment-related adverse effects, such as pain, skin irritation, bleeding and dizziness, will also be assessed. Assessments will be made before treatment, one month, three months and six months after the treatment course. The credibility of placebo treatment will also be assessed. Expected results: We expect that patients in the treatment group will have significant improvements on primary and secondary outcome measures, when compared with patients in the inert placebo group. Conclusion: This study will provide credible evidence regarding whether electroacupuncture is effective in reducing chronic neck pain. Patients, healthcare professionals, and government policy makers can make use of this information to improve clinical outcomes and reduce costs
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^†	Neck Pain
Intervention ^†	Device: electroacupuncture Device: Sham laser acupuncture
Study Arms / Comparison Groups	Experimental: Electroacupuncture treatment Sham Comparator: Sham laser acupuncture
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Active, not recruiting
Estimated Enrollment ^†	200
Estimated Completion Date	February 2009
Estimated Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^†	Inclusion Criteria: Adult male or female subjects age above 18 with mechanical neck pain for over three months. Exclusion Criteria: Patients who have received acupuncture treatment for any purpose in the last 6 months. Patients who will be unlikely to attend all treatment sessions. Patients with systemic diseases, such as diabetes or cardiovascular disorder. Patients with a history of traumatic injury of the neck or upper back from T1-T6, precious fracture or surgery to the neck, neurological deficits (e.g., muscle weakness or changes in spinal reflex jerks), a history of malignancy, congenital abnormality of the spine, or systemic bone and joint disorders (e.g., RA). Patients who are seeking compensation for neck-related condition. Patients who have needle phobia. Pregnant and breast feeding women.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00826215
Responsible Party	Dr. Shi Ping Zhang, School of Chinese Medicine, Hong Kong Baptist Universtiy
Secondary IDs ^††
Study Sponsor ^†	Hong Kong Baptist University
Collaborators ^††	The Hong Kong Polytechnic University
Investigators ^†
Information Provided By	Hong Kong Baptist University
Verification Date	January 2009
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.