Electroacupuncture for Chronic Neck Pain - Full Text View

Sponsors and Collaborators:	Hong Kong Baptist University The Hong Kong Polytechnic University
Information provided by:	Hong Kong Baptist University
ClinicalTrials.gov Identifier:	NCT00826215

Purpose

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	Intervention	Phase
Neck Pain	Device: electroacupuncture Device: Sham laser acupuncture	Phase II

MedlinePlus related topics: Acupuncture Neck Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain

Further study details as provided by Hong Kong Baptist University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Electroacupuncture treatment	Device: electroacupuncture Nine sections of 45 minutes electroacupuncture treatment in three weeks
2: Sham Comparator Sham laser acupuncture	Device: Sham laser acupuncture Sham laser acupuncture

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	School of Chinese Medicine, Hong Kong Baptist Universtiy ( Dr. Shi Ping Zhang )
Study ID Numbers:	04060191
Study First Received:	January 21, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826215 History of Changes
Health Authority:	Hong Kong: Committee on the use of human & animal subjects in teaching and research HKBU

Keywords provided by Hong Kong Baptist University:

mechanical
neck pain
chronic
acupuncture
chronic mechanical neck pain

Study placed in the following topic categories:

Signs and Symptoms
Neck Pain
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neck Pain
Neurologic Manifestations
Pain

ClinicalTrials.gov processed this record on May 06, 2009