Sensor Measurement of Acupuncture Needle Manipulation
|First Received Date ICMJE||February 11, 2005|
|Last Updated Date||February 26, 2007|
|Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Feasibility of use of needle torque sensor in clinical practice, education, and research|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00103675 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Sensor Measurement of Acupuncture Needle Manipulation|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Condition ICMJE||Back Pain|
|Intervention ICMJE||Procedure: Acupuncture|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||February 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Inclusion Criteria for Group 1 Participants:
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00103675|
|Other Study ID Numbers ICMJE||R01AT001121-01A1|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Center for Complementary and Integrative Health (NCCIH)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Center for Complementary and Integrative Health (NCCIH)|
|Verification Date||February 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP