Electroacupuncture for Chronic Neck Pain
|ClinicalTrials.gov Identifier: NCT00826215|
Recruitment Status : Unknown
Verified January 2009 by Hong Kong Baptist University.
Recruitment status was: Active, not recruiting
First Posted : January 22, 2009
Last Update Posted : January 22, 2009
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
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain||Device: electroacupuncture Device: Sham laser acupuncture||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||February 2009|
Nine sections of 45 minutes electroacupuncture treatment in three weeks
Sham Comparator: 2
Sham laser acupuncture
Device: Sham laser acupuncture
Sham laser acupuncture
- Change in neck pain specific disability index as measured by the Northwick Park Neck Pain Questionnaire (NPQ). [ Time Frame: 6 months ]
- 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 ]
- Adverse effects. [ Time Frame: 6 months ]