Ultraschallbildgebung bei myofaszialen Schmerzen
Entwicklung und Validierung eines nichtinvasiven multimodalen ultraschallbasierten Bildgebungs-Biomarkers für myofasziale Schmerzen
The goal of this observational study is to develop and validate a biomarker for lumbar myofascial pain (MP) based on ultrasound obtained measurements of the lumbar muscles and fascia. The investigators will use advanced machine learning approaches and validation in a randomized controlled trial. The main questions it aims to answer are:
- Will the deep learning-based marker reliably identify subjects from the 4 different groups: healthy, MP without trigger points, MP with latent trigger points, and MP with active trigger points?
- Will the deep learning-based marker accurately classify/predict the severity of MP in subjects with cLBP?
Participants in the healthy group will be asked to do the following tasks:
- Consent/Enrollment
- Measure Height/Weight
- Complete Questionnaires on REDCap
- Participate in Ultrasound Imaging Experiment Sessions
Participants in the chronic low back pain group will be asked to do the following tasks:
- Consent/Enrollment
- Complete Questionnaires on REDCap
- Measure Height/Weight
- Undergo a Standardized Clinical Exam
- Participate in Ultrasound Imaging Experiment Sessions
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The investigators propose to use multimodal ultrasound imaging to develop and validate a practical and inexpensive biomarker for lumbar myofascial pain, which shows sensitivity to change in relation to treatment. Myofascial pain (MP) is a frequent contributing factor to chronic low back pain (cLBP). It is associated with a range of tissue abnormalities, such as taught muscle bands, trigger points (TPs), and thoracolumbar fascia motion dysfunction, along with poor tissue elasticity. As a result, a composite biomarker for MP related to components of the syndrome is more likely to be plausible biologically, robust, and useful clinically for diagnosis and treatment. The investigators propose to study: 1. The echogenicity of latent and active trigger points, 2. The dynamic spatial-temporal tissue deformation quantified by strain tensors (compression, extension, and shear) in the thoracolumbar fascia and multifidus muscle, 3. The viscoelastic properties of the fascia and muscles measured by ultrasound shear wave elastography. In the R61 Phase (year 1 to 3) the investigators will use deep learning to integrate these measurements into a predictive biomarker and use established validation methods to test its ability to predict MP.
The investigators will determine the sensitivity and specificity of the biomarker to classify the myofascial components of pain, as well as the response to treatment (a diagnostic and predictive marker).
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- Kauffman Medical Building
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
The investigators are including healthy normal and cLBP subjects from ages 20 to 70.
Beschreibung
Inclusion/Exclusion Criteria for Healthy Normals (n=40):
- No history of chronic low back pain, myofascial pain of the neck or shoulders, or fibromyalgia.
- Ages 20-70 to be age appropriate to the cLBP subjects. The investigators will recruit 10 subjects per age decile (10 subjects ages 30-39 yrs., etc.).
- Any clinically unstable systemic illness that is judged to interfere
- with the trial
- Non-ambulatory status
- Not able to complete the questionnaires.
Inclusion Criteria CLBP:
- Age range 20-70 so that the age distribution is likely to roughly match the healthy normals
- Predominantly axial cLBP meeting the NIH definition of cLBP (at least 3 months on a daily basis) with a MP component (determined by a standardized clinical exam)
- Average pain score of > 3/10, with low back pain being the primary pain site
- cLBP meeting Quebec Task Force Classification System categories I-III (from axial pain only to pain radiating beyond the knee without neurological signs).
Exclusion Criteria CLBP:
- Back surgery within the past year
- Active worker's compensation or litigation claims since these patients are more likely to have exaggerated pain behavior
- New pain treatments within 2 weeks of enrollment
- Any clinically unstable systemic illness that is judged to interfere with the trial
- Non-ambulatory status
- Not able to complete the questionnaires.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Healthy Normals
Participants with no chronic pain over a three-year timeframe. |
See above, this is only a phenotyping study but NIH required us to register it as a trial. |
|
MP without TPs
Participants with chronic low back pain who are classified as having myofascial pain and no trigger points. |
See above, this is only a phenotyping study but NIH required us to register it as a trial. |
|
MP with latent TPs
Participants with chronic low back pain who are classified as having myofascial pain and latent trigger points. |
See above, this is only a phenotyping study but NIH required us to register it as a trial. |
|
MP with active TPs
Participants with chronic low back pain who are classified as having myofascial pain and active trigger points. |
See above, this is only a phenotyping study but NIH required us to register it as a trial. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Diagnosis of one of 3 MP-related categories
Zeitfenster: Study Visit 1 (week 1)
|
Participants to be diagnosed as normal, MP with trigger points, or MP with tender points only, as determined by standardized clinical examinations. |
Study Visit 1 (week 1)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Presence of Substantial MP
Zeitfenster: Study Visit 1 (week 1) - Study Visit 2 (week 2)
|
The presence of substantial MP (e.g., # active TPs and pressure pain threshold below 6.5 N/cm2) as determined by the standardized clinical examinations. |
Study Visit 1 (week 1) - Study Visit 2 (week 2)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kang Kim, PhD, University of Pittsburgh
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- STUDY22090014
- 1R61AT012282-01 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Depends on the specific request from an outside party
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .