Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103675
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2005-02-11
Brief Title:
Sensor Measurement of Acupuncture Needle Manipulation
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Acupuncture Needling Torque Sensor
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 sensors 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
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 sensors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None