Electroacupuncture for Chronic Neck Pain

NCT ID: NCT00826215

Last Updated: 2009-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-02-28

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

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Electroacupuncture treatment

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: DEVICE

Nine sections of 45 minutes electroacupuncture treatment in three weeks

2

Sham laser acupuncture

Group Type: SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type: DEVICE

Sham laser acupuncture

Interventions

electroacupuncture

Nine sections of 45 minutes electroacupuncture treatment in three weeks

Intervention Type: DEVICE

Sham laser acupuncture

Sham laser acupuncture

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: collaborator

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

School of Chinese Medicine, Hong Kong Baptist Universtiy

Other Identifiers

04060191

Identifier Type: -

Identifier Source: org_study_id