Acupuncture Outcomes Based Rehabilitation

Acupuncture Outcomes Based Rehabilitation Through Measurement of Fine Motor Control

Can acupuncture be quantified. This study sets out to observe if there are measurable effects of fine motor control that are attributable to acupuncture. The study utilizes an FDA approved medical device for measurements of fine motor control called the RU-Fit.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Acupuncture; Device: RU-Fit

Detailed Description

Context: Currently there is a high demand for evidence-based research in the field of Acupuncture. The medical practice of acupuncture has existed for thousands of years and purportedly has been successful at managing a wide array of health conditions. Producing objective/quantitative data that rule out any possibility of placebo effect has proved burdensome.

Objectives: This exploratory study seeks to determine if physiological measurements of fine motor control can be changed after receiving an acupuncture treatment. Can this change demonstrate the effectiveness of the treatment? Design, Setting, Participants, Interventions: This study looked at acupuncture patients undergoing treatments for pain relief, and general minor injury to determine whether or not observable changes could be detected in the fine motor control of the hands after acupuncture treatments.

Two groups of 50 subjects were used in the study. The test group was given a fine motor control test prior to and after their acupuncture therapy to determine if any changes could be measured.

The control group was given two fine motor control tests without acupuncture treatment with a 40 minute delay between the tests to replicate the test group timing. This study was conducted at a non-profit community clinic between the dates of 9/28/16 & 2/19/17.

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants were selected from the acupuncture patient population freely visiting the clinic. Patients were asked if they would be interested in a research study. They were informed about the objectives of the study, what their role would be and that this was a free non-invasive test that they would undergo before and after their regular acupuncture treatment. Before inclusion into the program, patients are provided with informed consent forms and after agreeing and signing the form, individuals then become participants.

Description

Inclusion Criteria:

• Male or female 13 years old or older
• Study participants were selected from the acupuncture patient population freely visiting the clinic. Patients were asked if they would be interested in a research study. They were informed about the objectives of the study, what their role would be and that this was a free non-invasive test that they would undergo before and after their regular acupuncture treatment. Before inclusion into the program, patients are provided with informed consent forms and after agreeing and signing the form, individuals then become participants.

Exclusion Criteria:

• Younger than 13 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acupuncture Intervention group; RU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments.	Procedure: Acupuncture; Alternative medicine therapeutic intervention; Device: RU-Fit; FDA approved medical device for the measurement of fine motor control
Control/ Non-Intervention; This group received no intervention but still had measurements of fine motor control gathered from RU-Fit medical device.	Device: RU-Fit; FDA approved medical device for the measurement of fine motor control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing Changes in Fine Motor Control from Acupuncture	Fine Motor Control measurements (probability percentage of normal capability) from RU-Fit, FDA approved medical device	Before and after acupuncture treatment or space of 40 minutes for control group between testing

Collaborators and Investigators

• Sponsor: Community Medical Foundation for Patient Safety
• Collaborators: Red Oak Instruments, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2016
• Primary Completion (Actual): January 21, 2017
• Study Completion (Actual): February 19, 2017

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 3, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 3, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: acupuncture; fine motor control; quantitative data; outcomes based rehabilitation
• Other Study ID Numbers: RU-Fit Acu 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No