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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2024-04-11

Brief Summary

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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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Detailed Description

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Conditions

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Trigger Finger Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Control

Patients received no intervention during cortisone injection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Distraction

Patients were instructed on a sham motor distraction task on the contralateral upper limb and performed this task during cortisone injection.

Group Type SHAM_COMPARATOR

Motor Distraction Task

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Ipsilateral Scratch Task

Intervention Type BEHAVIORAL

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

Interventions

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Ipsilateral Scratch Task

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

Intervention Type BEHAVIORAL

Motor Distraction Task

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes