Using the Gate Control Theory of Pain to Decrease Pain During Trigger Finger Corticosteroid Injections (TFGCT)

May 4, 2024 updated by: Aidan Crislip, Grand Canyon University

Closing the Gate: Investigating a No-Cost, Noninvasive, Patient-Driven Approach to Pain Reduction for Trigger Finger Injections

The goal of this clinical trial is to investigate a new noninvasive technique that patients may use to help reduce the pain that they experience during cortisone injections for trigger fingers. It will also help provide information that may help support the gate control theory of pain as a framework for understanding and managing acute pain.The main questions it aims to answer are:

Can a physical stimulus near the site of cortisone injection reduce the pain experienced by the patient during the injection? Does the physical stimulation or the cognitive distraction contribute more to pain relief?

Researchers will compare a physical stimulus near the injection site to a placebo (a similar task that theoretically should not reduce the experience of pain) to see if physical stimuli work to improve pain during injections.

Participants will:

Estimate how much pain they expect to experience during a cortisone injection Receive a cortisone injection for a trigger finger while performing one of three possible actions (control, placebo task, or the investigated physical stimulus near the injection site) Express how much pain they actually experienced during the injection

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • OrthoArizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Are at least 18 years of age.
  • Have been diagnosed with one or more "trigger fingers" of the index, middle, ring, or small fingers.
  • Have decided to try a cortisone injection for one or more trigger fingers today as advised by your physician.
  • Are able to read and understand these study procedures.

Exclusion Criteria:

  • Are severely visually impaired.
  • Have a history of spinal cord injury.
  • Have taken opioid pain medications in the last 28 days.
  • Are currently pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients received no intervention during cortisone injection.
Sham Comparator: Distraction
Patients were instructed on a sham motor distraction task on the contralateral upper limb and performed this task during cortisone injection.
Behavioral: Motor Distraction Task
Patients scratch the skin of the shoulder/neck contralateral to the injection site
Experimental: Experimental
Patients were instructed on the experimental task, involving scratching the upper limb ipsilateral to the site of the injection, and they performed this task during cortisone injection.
Behavioral: Ipsilateral Scratch Task
Patients scratch the skin within the relevant cervical dermatome, ipsilateral to the injection site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Score
Time Frame: Immediately after injection (within 10 seconds)
Patients denote the pain they experienced during the injection based on a standard 100-mm Visual Analog Scale. Scores range from 0-100, with lower scores indicating less pain. A score of 0 indicates no pain at all, while a score of 100 indicates the worst pain possible.
Immediately after injection (within 10 seconds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grand Canyon University

Investigators

  • Principal Investigator: Aidan Crislip, BS, Grand Canyon University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Actual)

April 11, 2024

Study Completion (Actual)

April 11, 2024

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2023-5842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Motor Distraction Task

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe