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Sensor Measurement of Acupuncture Needle Manipulation

Primary Purpose

Back Pain

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Back Pain focused on measuring Acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Group 1 Participants: Asymmetric chronic musculoskeletal back pain

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Feasibility of use of needle torque sensor in clinical practice, education, and research

    Secondary Outcome Measures

    Full Information

    First Posted
    February 11, 2005
    Last Updated
    February 26, 2007
    Sponsor
    National Center for Complementary and Integrative Health (NCCIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00103675
    Brief Title
    Sensor Measurement of Acupuncture Needle Manipulation
    Official Title
    Acupuncture Needling Torque Sensor
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Complementary and Integrative Health (NCCIH)

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to develop and test a sensor system capable of measuring acupuncture needle manipulation and torque in a clinical setting. Study hypothesis: Torque will be greater on the side of the back with musculoskeletal pain compared with the side without pain.
    Detailed Description
    Acupuncture is an ancient Chinese practice that involves the use of specialized needles to stimulate parts of the body. The number of Americans who use acupuncture services continues to grow each year. Two elements required to deliver high-quality acupuncture treatment are identification of the appropriate acupuncture points and proper manipulation of the acupuncture needle. Despite a growing awareness of the importance of proper needle techniques, no tool capable of objectively measuring needle manipulation in a clinical setting has ever been developed. Such a tool would have applications in acupuncture research, teaching, and clinical practice. This study will develop and test a simple hand-held sensor capable of making such objective needle torque measurements. There are two parts to this study. In Part 1, researchers will develop the hand-held sensor (called the AcuSensor) that will be mounted to the handle of an acupuncture needle and will measure torque during manual needle manipulation. In Part 2, the sensor will be tested for accuracy and reliability in three different groups. Group 1 will consist of patients with unilateral musculoskeletal back pain. Group 1 participants will undergo one session of acupuncture treatment while torque measurement and needle manipulation techniques are examined. In Group 2, practitioners and students at two leading acupuncture schools will use the AcuSensor during their teaching clinics. Teachers and students will complete a questionnaire to evaluate the sensor's usefulness. Experienced acupuncturists comprise Group 3; they will receive AcuSensor training and evaluate the performance of the AcuSensor in clinical practice. Information about the range and variability of torque measurements produced by different practitioners and techniques will be obtained from use of the sensor. Group 3 acupuncturists will also guess needle torque before and after training with the sensor turned off in order to determine the way AcuSensor training affects acupuncturists' sensory perception of needle grasp.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Back Pain
    Keywords
    Acupuncture

    7. Study Design

    Primary Purpose
    Educational/Counseling/Training
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Primary Outcome Measure Information:
    Title
    Feasibility of use of needle torque sensor in clinical practice, education, and research

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria for Group 1 Participants: Asymmetric chronic musculoskeletal back pain
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helene M. Langevin, MD
    Organizational Affiliation
    University of Vermont
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Ellis A, Wiseman N and Boss K. Fundamentals of Chinese acupuncture (1991). Brookline: Paradigm Publications.
    Results Reference
    background
    Citation
    Johns R. (1996) The art of acupuncture techniques. North Atlantic Books, Berkeley CA.
    Results Reference
    background
    Citation
    Lytle CD. An overview of acupuncture. Center for Devices and Radiological Health, U.S. Department of Health and Human Services, 1993
    Results Reference
    background
    Citation
    Yang J (1601) The golden needle and other odes of traditional acupuncture (Transl. Bertschinger, R. 1991) Churchill Livingstone, Edinburgh.
    Results Reference
    background

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    Sensor Measurement of Acupuncture Needle Manipulation

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