- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00444990
Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (LBP)
A Double-Blind, Randomized, Placebo-Controlled Study on Magnetic Field Therapy to Improve Chronic Lumbar Pain (Lbp)
OBJECTIVE:
The objective of this study is to determine if treatment with a flex pad impregnated with static/permanent magnets that can penetrate over 70 mm may improve the quality of chronic lumbar pain with reduction of pain scores.
HYPOTHESIS:
The researchers hypothesis that the application of a flex pad active magnetic therapy vs. sham if utilized daily during waking hours can reduce back pain and/or radicular pain. The null hypothesis is that treatment of subjects with chronic back pain with exposure to static/permanent magnetic fields have no measurable effect on chronic back pain scores and will be equal to the underlying placebo.
Studieoversigt
Detaljeret beskrivelse
DESIGN:
This is a double-blind, randomized, placebo-controlled study which will consist of two treatment groups. Treated subjects will receive a static/permanent magnetic flex pad with a nominal strength of less than 1000 Gauss. Control subjects will receive physically identical flex pad without magnet with a nominal surface field strength of 0 Gauss (placebo). The magnets will be contained in a pad with a Velcro cover and subjects will wear the pad attached to their undergarments/skin during waking hours. Dr. Weintraub will examine participants initially to look for presence or absence of radiculitis, range of motion, presence of absence of spasm, etc. The primary outcome measures will be reduction of chronic low back pain in comparison with prior baseline scores. It is recognized that these changes are subjective in nature. Patients will maintain their VAS scores on a monthly basis and at the end of the study, individuals will return all forms and be reevaluated by Dr. Weintraub. They will be asked specific questions regarding PGIC for bias, etc.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Michael I Weintraub, MD
- Telefonnummer: 914-941-0788
- E-mail: miwneuro@pol.net
Undersøgelse Kontakt Backup
- Navn: Susan E. Wolert
- Telefonnummer: 914-941-0788
- E-mail: miwneuro@pol.net
Studiesteder
-
-
New York
-
Briarcliff Manor, New York, Forenede Stater, 10510
- Rekruttering
- Michael I. Weintraub, MD
-
Kontakt:
- Susan E Wolert
- Telefonnummer: 914-941-0788
- E-mail: miwneuro@pol.net
-
Kontakt:
- Michael I Weintraub, MD
- Telefonnummer: 914-941-0788
- E-mail: miwneuro@pol.net
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female or male subjects age 18-80.
- Capable of understanding and complying with study protocols.
- Chronic lumbar pain for at least six months
Exclusion Criteria:
- Unable to understand informed consent (mental retardation, psychosis, communicative impairment).
- Cardiac pacemaker or other mechanical internal devices.
- Tumor in the spine/history of malignancy or tumor.
- Pregnancy.
- Prior spine surgery.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
VAS Pain scores/ SF 15 Pain descriptors/ PGIF/
|
Sekundære resultatmål
Resultatmål |
---|
Autonomic nervous system functions and range of motion
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Michael I. Weintraub, MD, Phelps Memorial Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 00781441
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Lændesmerter
-
Bozok UniversityAfsluttet
-
Otsuka Pharmaceutical Co., Ltd.Aktiv, ikke rekrutterendeHyper-low-density Lipoprotein (LDL) KolesterolæmiJapan
-
Health Services Academy, Islamabad, PakistanUkendtmHealth | Genoptagelse | Teach-back kommunikationPakistan
-
Rush University Medical CenterAfsluttetPatientuddannelse | Teach-back kommunikation | Efter besøgsinstruktioner | PatientforståelseForenede Stater
-
InQpharm GroupAfsluttetBlodtryk | Low Density Lipoprotein KolesterolniveauTyskland
-
Otsuka Pharmaceutical Co., Ltd.AfsluttetHyper-low-density Lipoprotein (LDL) KolesterolæmiJapan
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinAktiv, ikke rekrutterendeSimulering af fysisk sygdom | Trakeostomi komplikation | Teach-back kommunikationForenede Stater
-
Marmara UniversityAktiv, ikke rekrutterendeTeach-back kommunikationKalkun
-
National Taiwan University HospitalBuddhist Tzu Chi General Hospital; Taipei Medical University Hospital; E-DA... og andre samarbejdspartnereUkendtKoloskopi | Udrensning af tyktarm | Low-Reside diætTaiwan
-
Jordan Collaborating Cardiology GroupThe Cardiovascular Academy Group of the JCS; The Jordan Cardiac Society... og andre samarbejdspartnereAfsluttetAterosklerotisk kardiovaskulær risiko | Low-density-lipoprotein (LDL) kolesterolJordan
Kliniske forsøg med Magnetic Flex Pad
-
Weintraub, Michael I., MD, FACP, FAANSteven P. Cole, PhD.UkendtKroniske lændesmerterForenede Stater
-
Case Comprehensive Cancer CenterAfsluttetLaparoskopisk kirurgi | Vaginal kirurgiForenede Stater
-
Pluristem Ltd.AfsluttetTotal hofteprotese | MuskelskadeTyskland
-
National Institute of Allergy and Infectious Diseases...Circassia LimitedAfsluttetKatteallergi | Katte overfølsomhedCanada
-
Ewha Womans UniversityAfsluttetSlidgigtKorea, Republikken
-
Renal Research InstituteAfsluttetSlutstadie nyresygdomForenede Stater
-
Circassia LimitedAdiga Life Sciences, Inc.Afsluttet
-
Circassia LimitedCetero Research, San Antonio; Adiga Life Sciences, Inc.Afsluttet
-
National Taiwan University Hospital Hsin-Chu BranchUkendtSepsis | Perifer arteriesygdom | Diagnose | Perifer arterieokklusionTaiwan