Failure to recruit sufficient numbers due to the pandemic

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.

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.

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.