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

NCT06401473 | Completed

• 1 other identifier: IRB-2023-5842
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Trigger Finger; Pain

Keywords

Gate Control Theory of Pain; Injection

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Control

NO INTERVENTION

Patients received no intervention during cortisone injection.

Distraction

SHAM COMPARATOR

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

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

Interventions

Ipsilateral Scratch Task BEHAVIORAL

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

Experimental

Motor Distraction Task BEHAVIORAL

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

Distraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Grand Canyon University: lead

Study Sites (1)

OrthoArizona

Gilbert, Arizona, 85297, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder; Pain

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aidan Crislip, BS

  Grand Canyon University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients remained blinded to their assigned intervention until after all study procedures were complete. Injecting provider was technically blinded but was functionally unblinded at the time of the injection itself due to the visible and audible differences between each group throughout the course of the injection. Outcome assessor was blinded while instructing patients how to denote their pain level after the procedure, but was unblinded at the time of the injection. No input was given by the outcome assessor after they were unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Random assignment into one of three parallel groups: control, distraction, or experimental

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: September 11, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)