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

Pain Clinical Trial

— TFGCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401473
• Other study ID #: IRB-2023-5842
• Status: Completed
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: Grand Canyon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Trigger Finger
• Trigger Finger Disorder

Intervention

Behavioral:
• Ipsilateral Scratch Task
Patients scratch the skin within the relevant cervical dermatome, ipsilateral to the injection site
• Motor Distraction Task
Patients scratch the skin of the shoulder/neck contralateral to the injection site

Locations

Country	Name	City	State
United States	OrthoArizona	Gilbert	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Grand Canyon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Score	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)