HealthyNCT01456871
Finger Muscle Reaction After Electrical Stimuli to the Human Finger Pulley System; a Pilot Study
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP joint ligamento-muscular reflexes and their role is. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Guided insertion of electrodes and Electromyographic (EMG) recording
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Mar 2012
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Females aged 20-30
Who cannot join
- A history of any upper extremity injury or disorder in the non-dominant arm
- A history of any neurologic or bleeding disorder, or taking blood-thinning medication.
- Presence of Linbug-Comstock syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP joint ligamento-muscular reflexes and their role is.
Read the detailed description
Encapsulated nerve endings called mechanoreceptors are end components of afferent nerves and have specialized end organs surrounding the nerve terminal. Those receptors are concentrated in various human periarticular tissues. It is believed that these mechanoreceptors in the periarticular tissues are related to muscle reflexes. However, it is still unknown which type of mechanoreceptors contribute to the muscle reflexes and whether the mechanoreceptors excite and/or inhibit muscle activation. In the investigators previous studies, mechanoreceptors in the human proximal interphalangeal (PIP) joint and surrounding structures have been extensively examined. The investigators have identified that Pacini-like nerve endings in the PIP joint were found in substantial numbers in the junction of the C1 pulley and accessory collateral ligaments. The investigators hypothesize that the Pacini-like nerve endings in the junction of the C1 pulley generate activity in the associated flexor muscle/tendon in the finger.
- Conditions
- Healthy
- Being tested
- Guided insertion of electrodes, Electromyographic (EMG) recording
- Keywords
- Mechanoreceptors, PIP joint, Ligamento-muscular reflexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided insertion of electrodesProcedure or surgery
Fine-wire needle electrodes (30mm x 27gauge needle with a pairs of 0.051mm, insulated, hooked wires, Motion Lab Systems, Baton Rouge, LA) guided by sonographic evaluation of the pulley system using a Philips iU22 Ultrasound Machine (Philips Ultrasound Systems, Bothell, WA), a 17-5 MHz linear array transducer, and standard ultrasound gel.
Electromyographic (EMG) recordingProcedure or surgery
EMG signal recording, performed with an MA 300 EMG system (Motion Lab Systems, Baton Rouge, LA).
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult females | Females, aged 20 to 30 with no history of upper extremity injury or disorder in the non-dominant arm, no history of neurologic or bleeding disorder, and no evidence of Linburg-Comstock syndrome. Receives: Procedure: Guided insertion of electrodes; Procedure: Electromyographic (EMG) recording |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard A. Berger, Mayo Clinic
- Investigators
- Richard Berger, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456871
- Sponsor's protocol ID
- 11-004310
- Status last verified
- May 2013
- First submitted
- 19 Oct 2011
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finger Muscle Reaction After Electrical Stimuli to the Human Finger Pulley System; a Pilot Study
- ClinicalTrials.gov ID
- NCT01456871
- Acronym / sponsor ID
- 11-004310
- Conditions
- Healthy
- Keywords
- Mechanoreceptors, PIP joint, Ligamento-muscular reflexes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Oct 2011 (estimated)
- 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.
The purpose of the study is to gain a better understanding of mechanoreceptors in the PIP joint ligamento-muscular reflexes and their role is.
Detailed description
Encapsulated nerve endings called mechanoreceptors are end components of afferent nerves and have specialized end organs surrounding the nerve terminal. Those receptors are concentrated in various human periarticular tissues. It is believed that these mechanoreceptors in the periarticular tissues are related to muscle reflexes. However, it is still unknown which type of mechanoreceptors contribute to the muscle reflexes and whether the mechanoreceptors excite and/or inhibit muscle activation. In the investigators previous studies, mechanoreceptors in the human proximal interphalangeal (PIP) joint and surrounding structures have been extensively examined. The investigators have identified that Pacini-like nerve endings in the PIP joint were found in substantial numbers in the junction of the C1 pulley and accessory collateral ligaments. The investigators hypothesize that the Pacini-like nerve endings in the junction of the C1 pulley generate activity in the associated flexor muscle/tendon in the finger.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult females | – | Procedure: Guided insertion of electrodes, Procedure: Electromyographic (EMG) recordingFemales, aged 20 to 30 with no history of upper extremity injury or disorder in the non-dominant arm, no history of neurologic or bleeding disorder, and no evidence of Linburg-Comstock syndrome. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- Females aged 20-30
Key exclusion criteria (3 listed)
- A history of any upper extremity injury or disorder in the non-dominant arm
- A history of any neurologic or bleeding disorder, or taking blood-thinning medication.
- Presence of Linbug-Comstock syndrome
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 |
|---|---|---|
| Guided insertion of electrodesFine-wire needle electrodes (30mm x 27gauge needle with a pairs of 0.051mm, insulated, hooked wires, Motion Lab Systems, Baton Rouge, LA) guided by sonographic evaluation of the pulley system using a Philips iU22 Ultrasound Machine (Philips Ultrasound Systems, Bothell, WA), a 17-5 MHz linear array transducer, and standard ultrasound gel. | Procedure or surgery | Healthy adult females |
| Electromyographic (EMG) recordingEMG signal recording, performed with an MA 300 EMG system (Motion Lab Systems, Baton Rouge, LA). | Procedure or surgery | Healthy adult females |
Primary outcome
Not reported in the source record.
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 10 May 2013.
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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.
Richard Berger, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 3 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 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 10 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.