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CompletedNCT03459872Updated Mar 9, 2018

Acupuncture Outcomes Based Rehabilitation

An observational study in Pain, sponsored by Community Medical Foundation for Patient Safety. Completed. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-09.

Sponsored by Community Medical Foundation for Patient Safety · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
13 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • acupuncture
  • quantitative data
  • outcomes based rehabilitation
  • fine motor control
03

Who can participate

Ages eligible
13 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Younger than 13 years old
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Acupuncture Intervention group

    RU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments.

    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.

    Device: RU-Fit

Interventions

  • ProcedureAcupuncture

    Alternative medicine therapeutic intervention

  • DeviceRU-Fit

    FDA approved medical device for the measurement of fine motor control

05

What researchers measure

Primary outcomes

  1. Assessing Changes in Fine Motor Control from Acupuncture

    Fine Motor Control measurements (probability percentage of normal capability) from RU-Fit, FDA approved medical device

    Time frame: Before and after acupuncture treatment or space of 40 minutes for control group between testing

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03459872
Lead sponsor
Community Medical Foundation for Patient Safety
Collaborators
Red Oak Instruments, LLC
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Sep 28, 2016
Primary completion
Jan 21, 2017
Completion
Feb 19, 2017
Last update
Mar 9, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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