Myofascial PainNCT04555239
FDM for Subacute and Chronic Extremity Pain in the ED
A study testing Fascial Distortion Model (FDM) in people with Myofascial Pain and Chronic Pain, run by Carilion Clinic at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain, Chronic Pain, Extremities Disorders
- What is being tested?
- Fascial Distortion Model (FDM)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2020to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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:
- Peripheral neuropathy limiting sensation in the area of pain.
- Demyelinating disease involving the extremity where the pain is located.
- Orthopedic conditions:
- Joint replacement underlying location of pain.
- Prior orthopedic surgery to the area of pain.
- Fracture, known or suspected, underlying site of pain.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Carilion New River Valley Medical Center
Christiansburg, Virginia, 24073
Carilion Stonewall Jackson Hospital
Lexington, Virginia, 24450
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
Carilion Franklin Memorial Hospital
Rocky Mount, Virginia, 24151
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Fascial Distortion Model (FDM), Standard Care
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Distortion Model (FDM)Procedure or surgery
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.
Standard CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Fascial Distortion Model (FDM); Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Statistically Significant Pain Improvement
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Dec 2020
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Why it stopped: Failure to recruit sufficient numbers due to the pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Edward Via Virginia College of Osteopathic Medicine
- Responsible party
- Sponsor
- Investigators
- Carol A Bernier, D.O., Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555239
- Sponsor's protocol ID
- IRB-20-780
- Status last verified
- Apr 2021
- First submitted
- 26 Aug 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 22918828Franchignoni 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.
PubMed 24175606Binkley 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.
PubMed 10201543Gallagher 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.
PubMed 11719741Hudak 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.
PubMed 8773720Schulze 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.
PubMed 25379543Boucher 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.
PubMed 29507951Richter 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.
PubMed 28646809Hsu 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.
PubMed 30681429Abdolrazaghnejad 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.
PubMed 31172108National 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.
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.
PubMed 29332733Eisenhart 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.
PubMed 14527076Gummesson 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.
PubMed 12809562
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Subacute and Chronic Extremity Pain With Fascial Distortion Model (FDM) in the Emergency Department
- ClinicalTrials.gov ID
- NCT04555239
- Acronym / sponsor ID
- IRB-20-780
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit sufficient numbers due to the pandemic
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Edward Via Virginia College of Osteopathic Medicine
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care, Upper Extremity Pain | Active comparator | Other: Standard CarePatients will receive standard emergency department care as determined by their treating physician for their extremity pain. |
| Standard of Care, Lower Extremity Pain | Active comparator | Other: Standard CarePatients will receive standard emergency department care as determined by their treating physician for their extremity pain. |
| FDM, Upper Extremity Pain | Experimental | Procedure: Fascial Distortion Model (FDM), Other: Standard CarePatients 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. |
| FDM, Lower Extremity Pain | Experimental | Procedure: Fascial Distortion Model (FDM), Other: Standard CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Patient is able to speak, read, and write fluently in the English language.
- Patient is able to be reached by telephone for follow up.
Key exclusion criteria (24 listed)
- 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:
- Connective tissue diseases, such as Marfan's or Ehlers-Danlos.
- Dermatologic conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | FDM, Lower Extremity Pain, FDM, Upper Extremity Pain |
| Standard CareThe 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 | Other | FDM, Lower Extremity Pain, FDM, Upper Extremity Pain, Standard of Care, Lower Extremity Pain, Standard of Care, Upper Extremity Pain |
Primary outcome
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.
1 secondary outcome
Statistically Significant Pain Improvement
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Failure to recruit sufficient numbers due to the pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- BackgroundCapistrant, 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: PubMed 22918828Fink 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.
- Background: PubMed 24175606Franchignoni 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.
- Background: PubMed 10201543Binkley 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.
- Background: PubMed 11719741Gallagher 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.
- Background: PubMed 8773720Hudak 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.
- Background: PubMed 25379543Schulze 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.
- Background: PubMed 29507951Boucher 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.
- Background: PubMed 28646809Richter 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.
- Background: PubMed 30681429Hsu 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.
- Background: PubMed 31172108Abdolrazaghnejad 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.
- BackgroundNational 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol A Bernier, D.O. principal investigator
Carilion Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Distortion Model (FDM) in people with Myofascial Pain and Chronic Pain, run by Carilion Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure to recruit sufficient numbers due to the pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistically Significant Functional Improvement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555239, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.