FDM for Subacute and Chronic Extremity Pain in the ED
TerminatedNot applicableNCT04555239
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 that e…
Study details
- Official title
- Treatment of Subacute and Chronic Extremity Pain With Fascial Distortion Model (FDM) in the Emergency Department
- Conditions
- Myofascial Pain
- Chronic Pain
- Extremities Disorders
- Osteopathic Manipulation
- Interventions
- Procedure: Fascial Distortion Model (FDM)
- Other: Standard Care
- Sponsor
- Carilion Clinic
- Collaborators
- Edward Via Virginia College of Osteopathic Medicine
- Start date
- 2020-12-01
- Primary completion
- 2022-02-25
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Adults ages 18 and older with arm or leg pain for which they are presenting to the emergency department. 2. Pain has been present for greater than one week and less than three months. 3. Pain is described in terms amenable to treatment by FDM: * Single point of sharp pain overlying soft tissues correlating to a herniated trigger point. * Single point of sharp pain overlying bone correlating to a continuum distortion. * Line or band of pain overlying soft tissues or bone correlating to a trigger band. 4. Patient is able to speak, read, and write fluently in the English language. 5. Patient is able to be reached by telephone for follow up. 6. Patient has access to text messaging services, email, and the internet. Exclusion Criteria: 1. Inability to make informed consent (i.e. cognitive impairment or untreated psychiatric illness that would prohibit the ability to comprehend the risks and benefits of manipulative treatment vs. standard treatment). 2. Location of pain overlies major neurovascular structures (which would thus inhibit direct manipulation in that area). 3. Chronic systemic illness or medication treatment that would make patients prone to prolonged bruising or significant swelling after manipulation, including: * Active chemotherapy or radiation treatment. * Chronic steroid use. * Chronic wounds due to vascular disease or diabetes. * End stage renal disease on dialysis (risk of calciphylaxis). * Immunocompromised status. * Lymphedema. * Venous stasis insufficiency. 4. Connective tissue diseases, such as Marfan's or Ehlers-Danlos. 5. Dermatologic conditions: * Fragile skin that would be prone to tears with manipulation. * Skin lesions including open wounds or rashes overlying area of pain. 6. Neurologic conditions: * Peripheral neuropathy limiting sensation in the area of pain. * Demyelinating disease involving the extremity where the pain is located. 7. Orthopedic conditions: * Joint replacement underlying location of pain. * Prior orthopedic surgery to the area of pain. * Fracture, known or suspected, underlying site of pain. 8. Vascular conditions: * Superficial venous thrombosis (SVT), thrombophlebitis, or deep venous thrombosis (DVT) or suspicion for these underlying site of pain. * Current treatment with anticoagulants other than aspirin.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04555239