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NCT04555239 · ClinicalTrials.gov registry record · NA
FDM for Subacute and Chronic Extremity Pain in the ED
A NA study, sponsored by Carilion Clinic.
- Terminated
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT04555239 is a NA study that was terminated before completion, run by Carilion Clinic. The registered enrollment target is 19 participants.
The verdict
NCT04555239, a NA study, was terminated before completion, sponsored by Carilion Clinic.
- TERMINATED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study Summary
STUDY PURPOSE: To identify whether a low-cost, minimally invasive, one-time manual medicine intervention (fascial distortion model, FDM) is effective for the management of subacute and chronic extremity pain in the emergency department (ED). Demonstration of benefit may have far-reaching implications including reduction of pain medication use in the ED, shortened ED visit times, and future use of this intervention in the outpatient setting for chronic pain management. METHODS: We plan to conduct a randomized, unblinded clinical trial of FDM for the management of subacute and chronic extremity pain. 296 patients ages 18 and older seeking care in the ER for extremity pain that has been present for more than one week and less than three months will be recruited from four emergency departments within the Carilion Clinic hospital network over a 3-year time period. Patients are recruited into the study by treating clinicians in the ER and must describe their pain according to a pattern amenable to treatment with FDM: a. Single point of sharp pain overlying soft tissues correlating to a herniated trigger point; b. Single point of sharp pain overlying bone correlating to a continuum distortion; c. Line or band of pain overlying soft tissues or bone correlating to a trigger band. POPULATION: Adult patients presenting to Carilion Franklin Memorial Hospital (CFMH), Carilion New River Valley Hospital (CNRVH), Carilion Roanoke Memorial Hospital (CRMH), and Carilion Stonewall Jackson Hospital (CSJH). Prisoners and patients with known serious psychiatric comorbidities are specifically excluded. Specific Aims: The primary objective is to determine whether FDM yields significant improvement in function compared with standard care alone. The secondary objective is to determine whether FDM yields significant improvement in pain compared with standard care alone. Our exploratory objective is to determine whether FDM yields clinically significant improvements in pain and function tha
Interventions
- OTHER Standard Care
- PROCEDURE Fascial Distortion Model (FDM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2022-02-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04555239
The ClinicalTrials.gov registry entry for NCT04555239 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carilion Clinic, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT04555239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04555239 about?
NCT04555239 is a clinical study titled "FDM for Subacute and Chronic Extremity Pain in the ED". STUDY PURPOSE: To identify whether a low-cost, minimally invasive, one-time manual medicine intervention (fascial distortion model, FDM) is effective for the management of subacute and chronic extremity pain in the emergency department (ED). Demonstration of benefit may have far-reaching implication...
What is the current status of trial NCT04555239?
This trial is currently terminated. It is a NA study. The enrollment target is 19 participants. The study started on 2020-12-01. Estimated completion is 2022-02-25.
What interventions are being tested in trial NCT04555239?
The interventions under investigation include: Standard Care (OTHER), Fascial Distortion Model (FDM) (PROCEDURE).
Who is sponsoring clinical trial NCT04555239?
This trial is sponsored by Carilion Clinic, which has 45 total clinical trials registered on ClinicalTrials.gov.
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