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

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Key information

Conditions

Trigger Finger Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendinopathy Tendon Entrapment Trigger Finger Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoArizona

Gilbert, Arizona, 85297, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ipsilateral Scratch Task

Behavioral

Patients scratch the skin within the relevant cervical dermatome, ipsilateral to the injection site

Motor Distraction Task

Behavioral

Patients scratch the skin of the shoulder/neck contralateral to the injection site

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Grand Canyon University

Other

Registry information

Official study title

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

Acronym: TFGCT

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: May 6, 2024
Registry last updated: May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed