Acupuncture Outcomes Based Rehabilitation

Pain Clinical Trial

Official title:

Acupuncture Outcomes Based Rehabilitation Through Measurement of Fine Motor Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459872
• Other study ID #: RU-Fit Acu 1
• Status: Completed
• Phase: N/A
• First received: February 26, 2018
• Last updated: March 3, 2018
• Start date: September 28, 2016
• Est. completion date: February 19, 2017

Study information

• Verified date: March 2018
• Source: Community Medical Foundation for Patient Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 19, 2017
• Est. primary completion date: January 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• Acupuncture
Alternative medicine therapeutic intervention

Device:
• RU-Fit
FDA approved medical device for the measurement of fine motor control

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Community Medical Foundation for Patient Safety	Red Oak Instruments, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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