Trigger FingerTFGCTNCT06401473
Using the Gate Control Theory of Pain to Decrease Pain During Trigger Finger Corticosteroid Injections
A study testing Ipsilateral Scratch Task and Motor Distraction Task in people with Trigger Finger and Pain, run by Grand Canyon University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger, Pain
- What is being tested?
- Ipsilateral Scratch Task and Motor Distraction Task
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to 11 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Are severely visually impaired.
- Have a history of spinal cord injury.
- Have taken opioid pain medications in the last 28 days.
- Are currently pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closing the Gate: Investigating a No-Cost, Noninvasive, Patient-Driven Approach to Pain Reduction for Trigger Finger 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?
Read more
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
- Being tested
- Ipsilateral Scratch Task, Motor Distraction Task
- Keywords
- Gate Control Theory of Pain, Injection
- Medical subject headings
- Trigger Finger Disorder, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipsilateral Scratch TaskBehavioural
Patients scratch the skin within the relevant cervical dermatome, ipsilateral to the injection site
Motor Distraction TaskBehavioural
Patients scratch the skin of the shoulder/neck contralateral to the injection site
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Ipsilateral Scratch Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after injection (within 10 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start11 Sep 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment into one of three parallel groups: control, distraction, or experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Canyon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aidan Crislip, Grand Canyon University
- Investigators
- Aidan Crislip, BS, Principal investigator, Grand Canyon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401473
- Sponsor's protocol ID
- IRB-2023-5842
- Acronym
- TFGCT
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Gate: Investigating a No-Cost, Noninvasive, Patient-Driven Approach to Pain Reduction for Trigger Finger Injections
- ClinicalTrials.gov ID
- NCT06401473
- Acronym / sponsor ID
- TFGCT / IRB-2023-5842
- Conditions
- Trigger Finger, Pain
- Keywords
- Gate Control Theory of Pain, Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Grand Canyon UniversityUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Random assignment into one of three parallel groups: control, distraction, or experimental
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients received no intervention during cortisone injection. |
| Distraction | Sham comparator | Behavioral: Motor Distraction TaskPatients were instructed on a sham motor distraction task on the contralateral upper limb and performed this task during cortisone injection. |
| Experimental | Experimental | Behavioral: Ipsilateral Scratch TaskPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Are severely visually impaired.
- Have a history of spinal cord injury.
- Have taken opioid pain medications in the last 28 days.
- Are currently pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipsilateral Scratch TaskPatients scratch the skin within the relevant cervical dermatome, ipsilateral to the injection site | Behavioural | Experimental |
| Motor Distraction TaskPatients scratch the skin of the shoulder/neck contralateral to the injection site | Behavioural | Distraction |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aidan Crislip, BS principal investigator
Grand Canyon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ipsilateral Scratch Task and Motor Distraction Task in people with Trigger Finger and Pain, run by Grand Canyon University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Score (time frame: Immediately after injection (within 10 seconds)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.