- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07712458
A Study Of Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy
14. juli 2026 opdateret af: Ziying Yin, Mayo Clinic
Magnetic Resonance Elastography Assessment Of Chronic Low Back Pain Before And After A Manual Therapy Intervention
The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Melissa Bush
- Telefonnummer: 507-266-1008
- E-mail: Bush.Melissa1@mayo.edu
Studiesteder
-
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Adult males or females (age ≥ 18 years)
- Report chronic low back pain (≥3 months) (measured by patient history and clinical evaluation)
- Pain intensity reported at baseline must be ≥4 on the pain VAS scale
- Presence of myofascial pain features in the lumbar region (e.g., localized tenderness and/or trigger points identified by a qualified clinician/therapist)
- Able to lie in supine and prone positions for study procedures
- Be able to participate fully in all aspects of the study
- Have understood and signed study informed consent
Exclusion Criteria:
- Pregnancy or breastfeeding
- Patients with the inability to stay in a prone and supine position for the required procedure durations (e.g., ≥30 minutes at a time)
- Any contraindication to an MRI exam, or severe claustrophobia that would prevent safe completion of the scan
- Previous lumbar spine surgery or history of severe lumbar injury (e.g., fracture) that, in the investigation team's judgment, would interfere with participation or safety
- Patients with known bleeding disorders or current therapeutic anticoagulation that would increase risk of bruising/bleeding with massage
- Patients with skin conditions affecting the treatment area (e.g., rash, open wound, active dermatitis) or known allergy to any materials used during treatment (e.g., gels/cleaners), if applicable
- Receipt of a new pain treatment within 3 days of the study visit (e.g., injection, ablation, spinal manipulation, massage/manual therapy) that could confound pre/post measures
- Use of short-acting opioid analgesics or sedating medications within 24 hours of the study visit
- Have an implanted device in or near the treatment area that could interfere with safe application of external pressure
- Have used an investigational drug within 30 days of study enrollment
- History of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
- Clinically significant unstable neurologic or systemic illness that would preclude safe participation, as judged by the investigation team.
- Surgical intervention for pain within 1 month prior to enrollment
- Active infection, wound, or other external trauma to the areas to be treated
- Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
- Inability to provide consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Expert Manipulative Massage Automation (EMMA)
Subjects will receive one massage therapy session utilizing the EMMA system
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Participants will receive device-assisted massage therapy using EMMA (Expert Manipulative Massage Automation).
Each treatment session will last approximately 30 minutes.
The device will be operated using conservative settings with predefined maximum force and pressure limits.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in SII-derived mobility index
Tidsramme: Baseline, 30 minutes post-intervention
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Baseline, 30 minutes post-intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain, Enjoyment of Life, and General Activity (PEG) Scale Score
Tidsramme: Baseline, 30 minutes post-intervention
|
The Pain, Enjoyment of Life, and General Activity (PEG) scale is a 3-item participant-reported measure used to assess pain intensity and pain-related interference with enjoyment of life and general activity.
The total PEG score is calculated as the average of the 3 item scores and ranges from 0 to 10, with higher scores indicating greater pain severity and interference.
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Baseline, 30 minutes post-intervention
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Change in Spinal Range of Motion (ROM)
Tidsramme: Baseline, 30 minutes post-intervention
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Spinal range of motion will be assessed by a clinical assessor using a bubble inclinometer.
Measurements will include lumbar flexion and right and left lateral bending.
The outcome will be reported as the change from baseline in spinal range of motion, measured in degrees.
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Baseline, 30 minutes post-intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ziying Yin, Ph.D., Mayo Clinic
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. januar 2028
Studieafslutning (Anslået)
1. august 2028
Datoer for studieregistrering
Først indsendt
14. juli 2026
Først indsendt, der opfyldte QC-kriterier
14. juli 2026
Først opslået (Faktiske)
17. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-002257
- INTERSHIELD 26-002257 (Andet bevillings-/finansieringsnummer: Mayo Clinic Radiology)
Plan for individuelle deltagerdata (IPD)
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