ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture Outcomes Based Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

February 26, 2018
March 9, 2018
March 9, 2018
September 28, 2016
January 21, 2017   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Observational [Patient Registry]
Observational Model: Other
Time Perspective: Prospective
6 Months
Not Provided
Non-Probability Sample
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.
Pain
  • Procedure: Acupuncture
    Alternative medicine therapeutic intervention
  • Device: RU-Fit
    FDA approved medical device for the measurement of fine motor control
  • Acupuncture Intervention group
    RU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments.
    Interventions:
    • Procedure: Acupuncture
    • Device: RU-Fit
  • Control/ Non-Intervention
    This group received no intervention but still had measurements of fine motor control gathered from RU-Fit medical device.
    Intervention: Device: RU-Fit
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
February 19, 2017
January 21, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03459872
RU-Fit Acu 1
Yes
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
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
Community Medical Foundation for Patient Safety
Community Medical Foundation for Patient Safety
Red Oak Instruments, LLC
Not Provided
Community Medical Foundation for Patient Safety
March 2018