Sensor Measurement of Acupuncture Needle Manipulation

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00103675
First received: February 11, 2005
Last updated: February 26, 2007
Last verified: February 2007

February 11, 2005
February 26, 2007
September 2004
Not Provided
Feasibility of use of needle torque sensor in clinical practice, education, and research
Same as current
Complete list of historical versions of study NCT00103675 on ClinicalTrials.gov Archive Site
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Sensor Measurement of Acupuncture Needle Manipulation
Acupuncture Needling Torque Sensor

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Back Pain
Procedure: Acupuncture
Not Provided
  • Ellis A, Wiseman N and Boss K. Fundamentals of Chinese acupuncture (1991). Brookline: Paradigm Publications.
  • Johns R. (1996) The art of acupuncture techniques. North Atlantic Books, Berkeley CA.
  • Lytle CD. An overview of acupuncture. Center for Devices and Radiological Health, U.S. Department of Health and Human Services, 1993
  • Yang J (1601) The golden needle and other odes of traditional acupuncture (Transl. Bertschinger, R. 1991) Churchill Livingstone, Edinburgh.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
February 2007
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Inclusion Criteria for Group 1 Participants:

  • Asymmetric chronic musculoskeletal back pain
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00103675
R01 AT001121-01A1
Not Provided
Not Provided
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Helene M. Langevin, MD University of Vermont
National Center for Complementary and Alternative Medicine (NCCAM)
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP