Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial NA study, sponsored by Carilion Clinic.
NCT04555239 is a NA study that was terminated before completion, run by Carilion Clinic. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine whether a single FDM treatment provided in the ED yields significant improvement in function for patients with subacute and chronic extremity pain, and whether this effect endures over time.
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 |
Why NCT04555239 stopped before completion
NCT04555239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.
NCT04555239 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04555239's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI