FDM for Subacute and Chronic Extremity Pain in the ED

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

Interventions

PROCEDURE

Fascial Distortion Model (FDM)

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.

OTHER

Standard Care

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

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine

  collaborator OTHER

• Carilion Clinic

  lead OTHER

Principal Investigators

• Carol A Bernier, D.O. · Carilion Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-01

Primary Completion

2022-02-25

Completion

2022-02-25

Countries

• United States

Study Locations