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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipsilateral Scratch Task | Behavioral | Patients scratch the skin within the relevant cervical dermatome, ipsilateral to the injection site |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aidan Crislip, BS | Grand Canyon University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoArizona | Gilbert | Arizona | 85297 | United States |
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| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| D010146 | Pain |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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Random assignment into one of three parallel groups: control, distraction, or experimental
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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.
| Motor Distraction Task | Behavioral | Patients scratch the skin of the shoulder/neck contralateral to the injection site |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |