FDM for Subacute and Chronic Extremity Pain in the ED

March 22, 2022 updated by: Carilion Clinic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Carilion New River Valley Medical Center
      • Lexington, Virginia, United States, 24450
        • Carilion Stonewall Jackson Hospital
      • Roanoke, Virginia, United States, 24014
        • Carilion Roanoke Memorial Hospital
      • Rocky Mount, Virginia, United States, 24151
        • Carilion Franklin Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of Care, Upper Extremity Pain
Patients will receive standard emergency department care as determined by their treating physician for their extremity pain.
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
Active Comparator: Standard of Care, Lower Extremity Pain
Patients will receive standard emergency department care as determined by their treating physician for their extremity pain.
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
Experimental: FDM, Upper Extremity Pain
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.
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
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.
Experimental: FDM, Lower Extremity Pain
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Statistically Significant Functional Improvement
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Statistically Significant Pain Improvement
Time Frame: 6 months
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinically Significant Functional Improvement
Time Frame: 6 months

Whether FDM yields clinically significant improvements in function that last over time.

- Clinical significance is defined as a change of at least 11 points on the Disabilities of the Arm, Shoulder, and Hand (DASH) Score from baseline or change of at least 9 points on the Lower Extremity Functional Scale (LEFS) Score from baseline.
6 months
Clinically Significant Pain Improvement
Time Frame: 6 months
Whether FDM yields clinically significant improvements in pain pre-intervention that last over time. [Clinical significance is defined as 13 mm or greater improvement in visual analogue scale (VAS) score.]
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carilion Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Edward Via Virginia College of Osteopathic Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carol A Bernier, D.O., Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-20-780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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