- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03320863
The Enso Study for Chronic Low Back Pain (EPS)
A Multicenter Randomized Controlled Clinical Trial Evaluating the Effectiveness of a Novel Form of Non-Invasive Neuromodulation for Treatment of Chronic Low Back Pain
Studieoversigt
Detaljeret beskrivelse
Fifty subjects will be selected based on the inclusion criteria and then randomized to either the intervention group or the sham control group. Each subject will be randomly fitted with an Enso or a sham device and will be instructed to self-administer treatment daily for one hour or more per day for four weeks in both cohorts. Throughout the duration of the study, data will be recorded via a smartphone application regarding treatment usage and intensity, pain levels, the subject's impression of any changes in their functionality, and their opioid and non-opioid medication intake. Medication usage will also be tracked through the use of CURES 2.0 information and pill counts at specified study visits. Additional functional testing will be conducted at each study visit.
At the 4 week visit, the study blind will be broken, and subjects who were randomized to the sham group will be given the opportunity to cross over for an additional week in the study, using the active device.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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California
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San Francisco, California, Forenede Stater, 94143
- Rekruttering
- University of California Medical Center
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Kontakt:
- Bobby Tay, MD
- Telefonnummer: 415-353-2739
- E-mail: TayB@ucsf.edu
-
Kontakt:
- Krishn Khanna, MD
- Telefonnummer: 719-510-9613
- E-mail: Krishn.Khanna@ucsf.edu
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Mechanical (myofascial), axial back pain (focused around the spine)
- 6/10 or greater level of pain
- Functionally debilitated by their pain (e.g., difficulty walking)
- Minimal radicular symptoms with no effect on functionality, medication, quality of life
- Expressed desire to stop taking pain medications
- Expressed desire to improve disability
- 80% or greater of disability is due to pain in the low back (as opposed to other body areas)
- Experiencing chronic pain for at least 6 months
- Interested in being active, improving their functionality
- Comfortable with using technology in daily life
- Subject able to understand and grant informed consent
- Documented adherence with clinic follow up visits per medical records
- Has an email account
- Above 18 years old
Exclusion Criteria:
- Patients that do not own or have access to a smartphone
- Has spinal instability, joint instability, or grade 2 or greater spondylolisthesis with instability
- Primary symptoms due to spinal stenosis
- Source of back pain related to an acute nerve impingement
- Diagnosis of cancer/malignant tumors in the last 5 years
- Source of back pain is an infection
- Source of pain is a prior spinal fusion surgery
- Has a cardiac pacemaker, implanted defibrillator or other implanted electronic device
- Has radicular pain symptoms that affect functionality, quality of life or medication intake
- Has undergone surgery to solve pain related to the study indication in the past 6 months
- Patients with history of opioid, alcohol or drug abuse in the last 5 years, per investigator discretion
- Any psychiatric condition that may interfere with the study assessments or prevent the subject from complying with the requirements of the protocol, in the judgement of the investigator
- Inability to complete subjective data as required; e.g. on mobile application and questionnaires
- Pregnant women (as determined by self-report)
- Have severe epilepsy
- Have severe form of cardiovascular disease
- Any other disease, condition, or habit(s) that in the opinion of the Principal Investigator would interfere with study compliance or adversely affect study outcomes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Active or Enso Group
Active Enso device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
|
An active Enso device that delivers neuromodulation therapy.
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Ingen indgriben: Sham Group
Sham device use for one month, at least one hour daily, including coaching via a smartphone app and coaching phone calls regarding device usage.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Six Minute Walk Test
Tidsramme: Once a week for 4 weeks
|
Compare the change in patient's 6 Minute Walk Test (6MWT) between the Enso intervention group and the sham group using the validated 6MWT procedure.
|
Once a week for 4 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Functional back pain assessment
Tidsramme: Once a week for 4 weeks
|
Functional back pain assessment using a 0 to 10 Numeric Pain Intensity Scale, assessed immediately after the 6MWT.
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Once a week for 4 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Bobby Tay, MD, University of California, San Francisco
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Protocol 17-01
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Enso device
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Alpha Republic GmbHVienna General HospitalAfsluttet
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Thimble Bioelectronics, Inc.University of California, San FranciscoTrukket tilbage
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Hinge Health, IncAktiv, ikke rekrutterendeKronisk smerte | Kronisk knæsmerter | Rygsmerter, lavForenede Stater