FDM for Subacute and Chronic Extremity Pain in the ED

NCT04555239 | Terminated DMC

• 1 other identifier: IRB-20-780
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

Myofascial Pain; Chronic Pain; Extremities Disorders; Osteopathic Manipulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Statistically Significant Pain Improvement

  6 months

Other Outcomes (2)

• Clinically Significant Functional Improvement

  6 months

• Clinically Significant Pain Improvement

  6 months

Study Arms (4)

Standard of Care, Upper Extremity Pain

ACTIVE COMPARATOR

Patients will receive standard emergency department care as determined by their treating physician for their extremity pain.

Other: Standard Care

Standard of Care, Lower Extremity Pain

ACTIVE COMPARATOR

Patients will receive standard emergency department care as determined by their treating physician for their extremity pain.

Other: Standard Care

FDM, Upper Extremity Pain

EXPERIMENTAL

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); Other: Standard Care

FDM, Lower Extremity Pain

EXPERIMENTAL

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); Other: Standard Care

Interventions

Fascial Distortion Model (FDM) PROCEDURE

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.

FDM, Lower Extremity Pain; FDM, Upper Extremity Pain

Standard Care OTHER

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

FDM, Lower Extremity Pain; FDM, Upper Extremity Pain; Standard of Care, Lower Extremity Pain; Standard of Care, Upper Extremity Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Carilion Clinic: lead
• Edward Via Virginia College of Osteopathic Medicine: collaborator

Study Sites (4)

Carilion New River Valley Medical Center

Christiansburg, Virginia, 24073, United States

Location

Carilion Stonewall Jackson Hospital

Lexington, Virginia, 24450, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Carilion Franklin Memorial Hospital

Rocky Mount, Virginia, 24151, United States

Location

Related Publications (17)

• 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.

  BACKGROUND

• 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.

  PMID: 22918828 BACKGROUND

• 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.

  PMID: 24175606 BACKGROUND

• 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.

  PMID: 10201543 BACKGROUND

• 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.

  PMID: 11719741 BACKGROUND

• 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.

  PMID: 8773720 BACKGROUND

• 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.

  PMID: 25379543 BACKGROUND

• 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.

  PMID: 29507951 BACKGROUND

• 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.

  PMID: 28646809 BACKGROUND

• 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.

  PMID: 30681429 BACKGROUND

• 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.

  PMID: 31172108 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29332733 BACKGROUND

• 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.

  PMID: 14527076 BACKGROUND

• 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.

  PMID: 12809562 BACKGROUND

• 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.

  PMID: 11822520 BACKGROUND

• "Writing a Protocol." Writing a Protocol | CHOP Institutional Review Board, 2019, irb.research.chop.edu/writing-protocol.

  BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carol A Bernier, D.O.

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 18, 2020
• Study Start: December 1, 2020
• Primary Completion: February 25, 2022
• Study Completion: February 25, 2022
• Last Updated: April 4, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)