Sensor Measurement of Acupuncture Needle Manipulation

Back Pain Clinical Trial

Official title:

Acupuncture Needling Torque Sensor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103675
• Other study ID #: R01AT001121-01A1
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2005
• Last updated: February 26, 2007
• Start date: September 2004
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Group 1 Participants:

• Asymmetric chronic musculoskeletal back pain

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Back Pain

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

References & Publications (4)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of use of needle torque sensor in clinical practice, education, and research