Sensor Measurement of Acupuncture Needle Manipulation
Primary Purpose
Back Pain
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Back Pain focused on measuring Acupuncture
Eligibility Criteria
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
NCT ID
NCT00103675
First Posted
February 11, 2005
Last Updated
February 26, 2007
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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
Learn more about this trial
Sensor Measurement of Acupuncture Needle Manipulation
We'll reach out to this number within 24 hrs