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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
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 21, 2009
    Last Updated
    January 21, 2009
    Sponsor
    Hong Kong Baptist University
    Collaborators
    The Hong Kong Polytechnic University
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    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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