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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06401473
Acronym
TFGCT
Enrollment
105
Registered
2024-05-06
Start date
2023-09-11
Completion date
2024-04-11
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Trigger Finger

Keywords

Gate Control Theory of Pain, Injection

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

Interventions

BEHAVIORALIpsilateral Scratch Task

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

BEHAVIORALMotor Distraction Task

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

Sponsors

Grand Canyon University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS) ScoreImmediately 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026