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Electroacupuncture for Chronic Neck Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Hong Kong Baptist University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by:
Hong Kong Baptist University
ClinicalTrials.gov Identifier:
NCT00826215
First received: January 21, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
Electroacupuncture treatment
 Device: electroacupuncture
Nine sections of 45 minutes electroacupuncture treatment in three weeks
Sham Comparator: 2
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: Dr. Shi Ping Zhang, School of Chinese Medicine, Hong Kong Baptist Universtiy
ClinicalTrials.gov Identifier: NCT00826215     History of Changes
Other Study ID Numbers: 04060191
Study First Received: January 21, 2009
Last Updated: January 21, 2009
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

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013