PainNCT03459872
Acupuncture Outcomes Based Rehabilitation
An observational study of Pain, run by Community Medical Foundation for Patient Safety.
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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Acupuncture and RU-Fit
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2016to 19 Feb 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Younger than 13 years old
About this study
Official title: 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.
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.
- Conditions
- Pain
- Being tested
- Acupuncture, RU-Fit
- Keywords
- acupuncture, quantitative data, outcomes based rehabilitation, fine motor control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Alternative medicine therapeutic intervention
RU-FitDevice
FDA approved medical device for the measurement of fine motor control
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Intervention group | RU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments. Receives: 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. Receives: Device: RU-Fit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Changes in Fine Motor Control from Acupuncture
Fine Motor Control measurements (probability percentage of normal capability) from RU-Fit, FDA approved medical device
Measured: Before and after acupuncture treatment or space of 40 minutes for control group between testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start28 Sep 2016
- Primary completion21 Jan 2017
- Study completion19 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Community Medical Foundation for Patient Safety
- Sponsor type
- University, hospital or other
- Collaborators
- Red Oak Instruments, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459872
- Sponsor's protocol ID
- RU-Fit Acu 1
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Outcomes Based Rehabilitation Through Measurement of Fine Motor Control
- ClinicalTrials.gov ID
- NCT03459872
- Acronym / sponsor ID
- RU-Fit Acu 1
- Conditions
- Pain
- Keywords
- acupuncture, quantitative data, outcomes based rehabilitation, fine motor control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Community Medical Foundation for Patient SafetyUniversity, hospital or other
- Collaborators
- Red Oak Instruments, LLC
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 19 Feb 2017 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Intervention group | – | Procedure: Acupuncture, Device: RU-FitRU-Fit gathers measurements of fine motor control were gathered from this group before and after acupuncture treatments. |
| Control/ Non-Intervention | – | Device: RU-FitThis group received no intervention but still had measurements of fine motor control gathered from RU-Fit medical device. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Younger than 13 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlternative medicine therapeutic intervention | Procedure or surgery | Acupuncture Intervention group |
| RU-FitFDA approved medical device for the measurement of fine motor control | Device | Acupuncture Intervention group, Control/ Non-Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: No. Information will be shared regarding measurements that were obtained from medical device testing such as fine motor control
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Community Medical Foundation for Patient Safety.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.