Electroacupuncture for Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
electroacupuncture
Sham laser acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring mechanical, neck pain, chronic, acupuncture, chronic mechanical neck pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
1
2
Arm Description
Electroacupuncture treatment
Sham laser acupuncture
Outcomes
Primary Outcome Measures
Change in neck pain specific disability index as measured by the Northwick Park Neck Pain Questionnaire (NPQ).
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.
Adverse effects.
Full Information
NCT ID
NCT00826215
First Posted
January 21, 2009
Last Updated
January 21, 2009
Sponsor
Hong Kong Baptist University
Collaborators
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT00826215
Brief Title
Electroacupuncture for Chronic Neck Pain
Official Title
A Randomized Controlled Trial of the Long-Term Efficacy of Electroacupuncture for Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
February 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hong Kong Baptist University
Collaborators
The Hong Kong Polytechnic University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
mechanical, neck pain, chronic, acupuncture, chronic mechanical neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Electroacupuncture treatment
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham laser acupuncture
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Intervention Description
Nine sections of 45 minutes electroacupuncture treatment in three weeks
Intervention Type
Device
Intervention Name(s)
Sham laser acupuncture
Intervention Description
Sham laser acupuncture
Primary Outcome Measure Information:
Title
Change in neck pain specific disability index as measured by the Northwick Park Neck Pain Questionnaire (NPQ).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
Adverse effects.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Electroacupuncture for Chronic Neck Pain
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