FDM for Subacute and Chronic Extremity Pain in the ED

Study Overview
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Brief Summary
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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 endure over time. HYPOTHESIS: Patients treated with FDM will demonstrate statistically and clinically significant improvement in function and pain compared with those treated with standard care alone. SIGNIFICANCE: This is the first clinical trial of FDM in the United States and the first in an ED.

Detailed Description
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The application of FDM for the treatment of non-specific subacute and chronic extremity pain in the ED combined with standard care holds enormous promise. High-quality studies investigating whether single-episode FDM therapy in the ED is effective are needed. Our goal is to conduct a randomized, prospective clinical trial investigating the use of FDM plus standard ED pain management for non-specific subacute and chronic extremity compared with standard ED pain management. The anticipated outcome of this study is statistically and clinically significant improvement in function and pain in those treated with FDM compared with those compared with standard emergency department care alone for their extremity pain. Demonstration of such results would provide stronger evidence base for manual manipulation, particularly in the emergency department setting. This is a low-cost intervention that can be learned easily by physicians and providers of a variety of backgrounds (advanced care practitioners, physical therapists, etc.) and can thus provide an excellent alternative for pain management as opposed to our traditional approaches to pain such as rest, ice, compression, and elevation (RICE), and medications such as NSAID (non-steroidal anti-inflammatory drugs) and acetaminophen. We all realize that part of the reason we are struggling with an opioid epidemic in our country is that our traditional approaches to pain management are not always enough and that patients subsequently become dependent upon stronger medications for pain control that unfortunately have addictive properties as side effects. If FDM proves to be a successful intervention for managing subacute and chronic pain in the emergency department with a single treatment, imagine its applicability on a wider scale in the outpatient setting for chronic pain management and how this could help us combat the current opioid crisis.

Official Title
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Treatment of Subacute and Chronic Extremity Pain With Fascial Distortion Model (FDM) in the Emergency Department

Conditions
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Myofascial Pain, Chronic Pain, Extremities Disorders, Osteopathic Manipulation

Intervention / Treatment
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* Procedure: Fascial Distortion Model (FDM)
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ages 18 and older with arm or leg pain for which they are presenting to the emergency department. Pain has been present for greater than one week and less than three months. 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. Patient is able to speak, read, and write fluently in the English language. Patient is able to be reached by telephone for follow up. Patient has access to text messaging services, email, and the internet. Exclusion Criteria: 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). Location of pain overlies major neurovascular structures (which would thus inhibit direct manipulation in that area). 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. Connective tissue diseases, such as Marfan's or Ehlers-Danlos. Dermatologic conditions: Fragile skin that would be prone to tears with manipulation. Skin lesions including open wounds or rashes overlying area of pain. Neurologic conditions: Peripheral neuropathy limiting sensation in the area of pain. Demyelinating disease involving the extremity where the pain is located. Orthopedic conditions: Joint replacement underlying location of pain. Prior orthopedic surgery to the area of pain. Fracture, known or suspected, underlying site of pain. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care, Upper Extremity Pain<br>Patients will receive standard emergency department care as determined by their treating physician for their extremity pain. | Other: Standard Care<br>* The usual standard of care for extremity pain varies from provider to provider and varies from patient to patient depending upon their comorbidities but often includes some combination of the following: X-rays, if suspicion for fracture exists Venous duplex ultrasound, if suspicion for DVT/SVT exists Computed tomography (CT) angiogram (CTA), if suspicion for arterial occlusion exists C-reactive Protein (CRP)/erythrocyte sedimentation rate (ESR)/arthrocentesis is suspicion if suspicion for septic arthritis exists Arthrocentesis if suspicion for gout exists Splinting/casting/immobilization NSAIDs, Tylenol, or opioids for pain control Possibly trigger point injections Possibly osteopathic manipulation Recommendations to use RICE (rest, ice, compression, elevation) at home Physical/occupational therapy referral Orthopedic referral<br>|
| Active Comparator: Standard of Care, Lower Extremity Pain<br>Patients will receive standard emergency department care as determined by their treating physician for their extremity pain. | Other: Standard Care<br>* The usual standard of care for extremity pain varies from provider to provider and varies from patient to patient depending upon their comorbidities but often includes some combination of the following: X-rays, if suspicion for fracture exists Venous duplex ultrasound, if suspicion for DVT/SVT exists Computed tomography (CT) angiogram (CTA), if suspicion for arterial occlusion exists C-reactive Protein (CRP)/erythrocyte sedimentation rate (ESR)/arthrocentesis is suspicion if suspicion for septic arthritis exists Arthrocentesis if suspicion for gout exists Splinting/casting/immobilization NSAIDs, Tylenol, or opioids for pain control Possibly trigger point injections Possibly osteopathic manipulation Recommendations to use RICE (rest, ice, compression, elevation) at home Physical/occupational therapy referral Orthopedic referral<br>|
| Experimental: FDM, Upper Extremity Pain<br>Patients will receive the FDM intervention for their extremity pain. They may also receive standard emergency department care as determined by their treating physician for their extremity pain. | Procedure: Fascial Distortion Model (FDM)<br>* Only treatment of herniated trigger points, continuum distortions, and/or trigger bands will be performed. Herniated trigger points are single areas of sharp pain within soft tissue. Continuum distortions are single points of sharp pain overlying bony tissues. Trigger bands are lines of pain overlying either soft or bony tissues. Treatment with FDM is performed using firm, direct pressure over the area of the patient's pain with the provider's thumb. This pressure is applied at a single point or area indicated by the patient for herniated trigger points and continuum distortions, and along the indicated line of pain for trigger bands.<br>Other: Standard Care<br>* The usual standard of care for extremity pain varies from provider to provider and varies from patient to patient depending upon their comorbidities but often includes some combination of the following: X-rays, if suspicion for fracture exists Venous duplex ultrasound, if suspicion for DVT/SVT exists Computed tomography (CT) angiogram (CTA), if suspicion for arterial occlusion exists C-reactive Protein (CRP)/erythrocyte sedimentation rate (ESR)/arthrocentesis is suspicion if suspicion for septic arthritis exists Arthrocentesis if suspicion for gout exists Splinting/casting/immobilization NSAIDs, Tylenol, or opioids for pain control Possibly trigger point injections Possibly osteopathic manipulation Recommendations to use RICE (rest, ice, compression, elevation) at home Physical/occupational therapy referral Orthopedic referral<br>|
| Experimental: FDM, Lower Extremity Pain<br>Patients will receive the FDM intervention for their extremity pain. They may also receive standard emergency department care as determined by their treating physician for their extremity pain. | Procedure: Fascial Distortion Model (FDM)<br>* Only treatment of herniated trigger points, continuum distortions, and/or trigger bands will be performed. Herniated trigger points are single areas of sharp pain within soft tissue. Continuum distortions are single points of sharp pain overlying bony tissues. Trigger bands are lines of pain overlying either soft or bony tissues. Treatment with FDM is performed using firm, direct pressure over the area of the patient's pain with the provider's thumb. This pressure is applied at a single point or area indicated by the patient for herniated trigger points and continuum distortions, and along the indicated line of pain for trigger bands.<br>Other: Standard Care<br>* The usual standard of care for extremity pain varies from provider to provider and varies from patient to patient depending upon their comorbidities but often includes some combination of the following: X-rays, if suspicion for fracture exists Venous duplex ultrasound, if suspicion for DVT/SVT exists Computed tomography (CT) angiogram (CTA), if suspicion for arterial occlusion exists C-reactive Protein (CRP)/erythrocyte sedimentation rate (ESR)/arthrocentesis is suspicion if suspicion for septic arthritis exists Arthrocentesis if suspicion for gout exists Splinting/casting/immobilization NSAIDs, Tylenol, or opioids for pain control Possibly trigger point injections Possibly osteopathic manipulation Recommendations to use RICE (rest, ice, compression, elevation) at home Physical/occupational therapy referral Orthopedic referral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically Significant Functional Improvement | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistically Significant Pain Improvement | To determine whether a single FDM treatment provided in the emergency department yields significant improvement in pain for patients with subacute and chronic extremity pain, and whether this effect endures over time. | 6 months |