Electroacupuncture for Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00826215
• Other study ID #: 04060191
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 21, 2009
• Last updated: January 21, 2009
• Start date: March 2007
• Est. completion date: February 2009

Study information

• Verified date: January 2009
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Committee on the use of human & animal subjects in teaching and research HKBU
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Device:
• electroacupuncture
Nine sections of 45 minutes electroacupuncture treatment in three weeks
• Sham laser acupuncture
Sham laser acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Baptist University	The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neck pain specific disability index as measured by the Northwick Park Neck Pain Questionnaire (NPQ).		6 months	No
Secondary	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.		6 months	No
Secondary	Adverse effects.		6 months	Yes