Clinical trial NCT04555239: FDM for Subacute and Chronic Extremity Pain in the ED
Official title: Treatment of Subacute and Chronic Extremity Pain With Fascial Distortion Model (FDM) in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myofascial Pain
Chronic Pain
Extremities Disorders
Osteopathic Manipulation
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Edward Via Virginia College of Osteopathic Medicine
First posted: 2020-09-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Statistically Significant Functional Improvement
timeFrame: 6 months
Secondary outcomes:
measure: Statistically Significant Pain Improvement
timeFrame: 6 months
Other outcomes:
measure: Clinically Significant Functional Improvement
timeFrame: 6 months
measure: Clinically Significant Pain Improvement
timeFrame: 6 months
Locations:
city: Christiansburg
country: United States
facility: Carilion New River Valley Medical Center
state: Virginia
city: Lexington
country: United States
facility: Carilion Stonewall Jackson Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Rocky Mount
country: United States
facility: Carilion Franklin Memorial Hospital
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Carol A Bernier, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Capistrant, Todd A., and Steve LeBeau. Why Does It Hurt?: the Fascial Distortion Model: a New Paradigm for Pain Relief and Restored Movement. Beaver's Pond Press, 2014.
citation: Fink M, Schiller J, Buhck H. [Efficacy of a manual treatment method according to the fascial distortion model in the management of contracted ("frozen") shoulder]. Z Orthop Unfall. 2012 Sep;150(4):420-7. doi: 10.1055/s-0032-1314996. Epub 2012 Aug 23. German.
citation: Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. Minimal clinically important difference of the disabilities of the arm, shoulder and hand outcome measure (DASH) and its shortened version (QuickDASH). J Orthop Sports Phys Ther. 2014 Jan;44(1):30-9. doi: 10.2519/jospt.2014.4893. Epub 2013 Oct 30.
citation: Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
citation: Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
citation: Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
citation: Schulze C, Finze S, Bader R, Lison A. Treatment of medial tibial stress syndrome according to the fascial distortion model: a prospective case control study. ScientificWorldJournal. 2014;2014:790626. doi: 10.1155/2014/790626. Epub 2014 Oct 14.
citation: Boucher JD, Figueroa J. Restoration of Full Shoulder Range of Motion After Application of the Fascial Distortion Model. J Am Osteopath Assoc. 2018 May 1;118(5):341-344. doi: 10.7556/jaoa.2018.044.
citation: Richter D, Karst M, Buhck H, Fink MG. Efficacy of Fascial Distortion Model Treatment for Acute, Nonspecific Low-Back Pain in Primary Care: A Prospective Controlled Trial. Altern Ther Health Med. 2017 Sep;23(5):AT5522. Epub 2017 Jun 23.
citation: Hsu JR, Mir H, Wally MK, Seymour RB; Orthopaedic Trauma Association Musculoskeletal Pain Task Force. Clinical Practice Guidelines for Pain Management in Acute Musculoskeletal Injury. J Orthop Trauma. 2019 May;33(5):e158-e182. doi: 10.1097/BOT.0000000000001430.
citation: Abdolrazaghnejad A, Banaie M, Tavakoli N, Safdari M, Rajabpour-Sanati A. Pain Management in the Emergency Department: a Review Article on Options and Methods. Adv J Emerg Med. 2018 Jun 24;2(4):e45. doi: 10.22114/AJEM.v0i0.93. eCollection 2018 Fall.
citation: National Center for Health Statistics. "National Hospital Ambulatory Medical Care Survey: 2016 Emergency Department Summary Tables." CDC.gov, 2016, www.cdc.gov/nchs/data/nhamcs/web_tables/2016_ed_web_tables.pdf.
citation: Thalhamer C. A fundamental critique of the fascial distortion model and its application in clinical practice. J Bodyw Mov Ther. 2018 Jan;22(1):112-117. doi: 10.1016/j.jbmt.2017.07.009. Epub 2017 Jul 25.
citation: Eisenhart AW, Gaeta TJ, Yens DP. Osteopathic manipulative treatment in the emergency department for patients with acute ankle injuries. J Am Osteopath Assoc. 2003 Sep;103(9):417-21.
citation: Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
citation: Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001 Sep;10(5):697-706. doi: 10.1046/j.1365-2702.2001.00525.x.
citation: "Writing a Protocol." Writing a Protocol | CHOP Institutional Review Board, 2019, irb.research.chop.edu/writing-protocol.