Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minocycline to Reduce Pain After Carpal Tunnel Release

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: NCT02051296
Recruitment Status : Completed
First Posted : January 31, 2014
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Catherine Curtin, VA Palo Alto Health Care System

Brief Summary:

The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release.

The investigators' hypothesis is that minocycline will reduce post-operative pain.


Condition or disease Intervention/treatment Phase
Chronic Pain Post-operative Pain Drug: Minocycline Drug: placebo Phase 2

Detailed Description:

This is a double blinded randomized controlled trial. Patients are given 100mg of minocycline 2 hours prior to their procedure and then 100mg two times a day for 5 days. The subjects are then contacted daily to check their level of pain. The investigators' outcome of interest is time to pain resolution.

The investigators will perform a futility analysis to assess if a larger trial would be a reasonable next step after this pilot study.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Trial of Minocycline for Pain After Carpal Tunnel and Trigger Release
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: minocycline
perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID
Drug: Minocycline
RCT blinded placebo trial
Other Name: Minocycline Hydrochloride

Placebo Comparator: Placebo
PLacebo
Drug: placebo
RCT blinded placebo trial




Primary Outcome Measures :
  1. Time to Pain Resolution [ Time Frame: up to 365 days ]
    the time until patient answers no pain at surgical site for three consecutive days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult, Veteran,

Exclusion Criteria:

  • Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051296


Locations
Layout table for location information
United States, California
Palo Alto VA
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Catherine Curtin, MD Palo Alto Veterans Hsopital

Layout table for additonal information
Responsible Party: Catherine Curtin, Staff Physician, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02051296     History of Changes
Other Study ID Numbers: RX000487
First Posted: January 31, 2014    Key Record Dates
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain, Postoperative
Carpal Tunnel Syndrome
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents