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Acupuncture Outcomes Based Rehabilitation

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ClinicalTrials.gov Identifier: NCT03459872
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Red Oak Instruments, LLC
Information provided by (Responsible Party):
Community Medical Foundation for Patient Safety

Brief Summary:
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.

Condition or disease Intervention/treatment
Pain 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 [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Acupuncture Outcomes Based Rehabilitation Through Measurement of Fine Motor Control
Actual Study Start Date : September 28, 2016
Actual Primary Completion Date : January 21, 2017
Actual Study Completion Date : February 19, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Responsible Party: Community Medical Foundation for Patient Safety
ClinicalTrials.gov Identifier: NCT03459872     History of Changes
Other Study ID Numbers: RU-Fit Acu 1
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Community Medical Foundation for Patient Safety:
acupuncture
quantitative data
outcomes based rehabilitation
fine motor control