Konventionel eller bipolær SIJ RFA
Konventionel eller bipolær radiofrekvensablation til behandling af sacroiliacale ledsmerter? COBRA-SIJ-undersøgelsen, et dobbeltblindet, randomiseret, sammenlignende forsøg.
Specifikke formål Det sacroiliacale ledkompleks (SIJC) er et diathrodialt, synovialled og posteriort ligamentøst netværk, der modtager både anterior innervation fra lumbosacral plexus såvel som posterior sensorisk innervation via det posterior sakrale netværk (PSN). PSN er omfattet af de laterale grene S1-S3 posterior rami, med variable bidrag fra S4 laterale gren og L5 dorsale ramus. Smertesignaler, der stammer fra SIJC, kan afbrydes med billedstyret perkutan radiofrekvensablation (RFA) af PSN, hvorved smerte og handicap reduceres hos nøje udvalgte patienter.
En tidligere systematisk gennemgang vurderede, at 32-89 % af patienterne opnår mindst 50 % smertelindring i seks måneder efter en eller anden form for PSN-ablation. Mange eksperter har mistanke om, at heterogene RFA-teknikker og -teknologi er ansvarlige for de variable succesrater set på tværs af publicerede undersøgelser. Cadaverisk arbejde tyder på, at målretning af PSN med en stor bipolær strimmellæsioner ville resultere i >95 % PSN neural capture sammenlignet med en mindre læsion produceret ved en konventionel, monopolær, periforaminal RFA-teknik, som kan fange så lavt som 2,5 % af PSN. Nimbus er en almindeligt anvendt multi-tined RFA-sonde, hvis store bipolære læsionsstørrelse gør den til en ideel mulighed for komplet PSN neural ablation. Både Nimbus (N-SIJRFA) og konventionelle (C-SIJRFA) teknikker og teknologier er almindeligt anvendte; der er dog ingen prospektive RCT'er, der sammenligner dem, og den kliniske betydning forbliver ukendt.
Problem: Der er ingen randomiserede kontrollerede forsøg, der sammenligner nye teknologier som N-SIJRFA med C-SIJRFA.
Formål: At sammenligne smerte- og handicapresultater hos patienter med bekræftede SIJC-smerter efter randomisering til enten N-SIJRFA eller C-SIJRFA.
Central hypotese: N-SIJRFA vil være mere effektiv til at forbedre smerte og funktion sammenlignet med patienter behandlet med C-SIJRFA efter 3, 6, 12, 18 og 24 måneder.
Specifikke mål:
1. Sammenlign andelen af deltagere, der rapporterer ≥50 % smertelindring ved Numeric Pain Rating Scale (NPRS) efter N-SIJRFA versus C-SIJRFA.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Lænderygsmerter påvirker flertallet af individer på et tidspunkt i deres liv. Den estimerede punktprævalens af lænderygsmerter i 2015 var 7,3 %, hvilket indikerer, at 540 millioner kan være påvirket på ethvert givet tidspunkt (1). Ætiologien af lænderygsmerter kan være multifaktoriel, men tilskrives ofte nociception opstået sacroiliac joint complex (SIJC) hos så mange som 15-30 % af patienterne (2). SIJC er et diathrodialt, synovialt led, der modtager både anterior innervation fra lumbosacral plexus såvel som posterior sensorisk innervation via det posteriore sakrale netværk (PSN) (3). PSN består af de laterale grene S1-S3 posterior rami, med variable bidrag fra S4 laterale gren og L5 dorsale ramus (3-6). Disse er blevet målrettet for neurotomi oftest med billedstyret perkutan radiofrekvensablation (RFA) (7), men også med perkutan kryoneurolyse (8), kemisk neurolyse (9), endoskopisk-guidet RFA (10) og MR højfrekvent ultralyd behandling (MRI-HIFU) (11).
Tidligere systematisk gennemgang har antydet, at 32-89 % af patienterne kan opnå mindst 50 % smertelindring i seks måneder, mens 11-44 % af patienterne opnåede 100 % smertelindring i samme periode (12). Selvom elementer af patientvalg sandsynligvis påvirker dette estimat (13), har undersøgelser brugt en række forskellige RFA-teknikker til at målrette PSN, hvilket også kan påvirke succesraterne. Få undersøgelser har direkte sammenlignet disse teknikker, men kadaverisk arbejde har antydet, at målretning af PSN med bipolære strimmellæsioner resulterer i væsentligt højere hastigheder af neural indfangning sammenlignet med periforaminal RFA udført med konventionelle monopolære elektroder (6). Ydermere kan hastigheden af fuldstændig neural indfangning med en periforaminal konventionel monopolær RFA være så lav som 12,5 %, hvilket måske er en af grundene til, at nogle kliniske undersøgelser har vist øget sandsynlighed for succes i grupper behandlet med teknologier, der vides at skabe større læsioner (13, 14). Lignende effektivitet er blevet observeret for periforaminale teknikker med både konventionel monopolær sammenlignet med større afkølede monopolære læsioner (15), såvel som mellem store kontinuerte læsioner multi-elektrode læsioner sammenlignet med periforaminal konventionel monopolær teknik (16). Ingen undersøgelse har imidlertid direkte sammenlignet en bipolær strimmellæsion ved brug af en "palisade"-teknik (N-SIJRFA) med en konventionel monopolær periforaminal metode, hvoraf sidstnævnte er almindeligt anvendt i mange praksismiljøer.
Det primære formål med den aktuelle undersøgelse er at evaluere effektiviteten af RFA af PSN ved hjælp af en bipolar "palisade"-teknik til at skabe en kontinuerlig striplæsion sammenlignet med konventionel monopolær periforaminal teknik i behandlingen af patienter med sacroiliacale ledkomplekssmerter. I betragtning af resultaterne af nyere kadaveriske undersøgelser kan resultaterne af det foreslåede arbejde væsentligt påvirke det nuværende behandlingsparadigme for PSN-neurotomi.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Utah
-
Farmington, Utah, Forenede Stater, 84025
- University of Utah Farmington Health Center
-
Salt Lake City, Utah, Forenede Stater, 84108
- University of Utah Orthopaedic Center
-
South Jordan, Utah, Forenede Stater, 84009
- University of Utah South Jordan Health Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Voksne deltagere i alderen 18-90 år med mindst 3 måneders lænderygsmerter, som ikke har reageret på mindst 3 måneders konservativ behandling.
- 7-dages gennemsnitlig NPRS for lænderygsmerter på mindst 4/10 ved baseline
- Smerter lindres med mindst 50 % ved enten en fluoroskopisk-styret intraartikulær sacroiliac-ledinjektion inklusive en lokalbedøvelse og en fluoroskopisk-styret PSN-blok eller dobbelte fluoroskopisk-guidede PSN-blokke.
- Deltagere, der er i stand til at forstå og give samtykke på engelsk og i stand til at overholde de anvendte resultatinstrumenter.
En smertedagbog med passende diagnostiske kategorier af lindring (100 % lindring, 80-99 % lindring osv.) vil blive leveret. Varighed af smertelindring vil ikke blive brugt, da det har vist sig kun at forbedre diagnostisk sikkerhed marginalt (17).
Ekskluderingskriterier:
- Historien om SIJ-fusion.
- Symptomatisk hofteartrose
- Aktiv lumbal radikulær smerte
- Bevis på hardwareløsning (hos deltagere med tidligere lænde- eller lumbosakral fusion).
- Tilstedeværelse af pacemaker eller neurostimulator.
- Kronisk udbredt smerte eller somatoform lidelse (f.eks. fibromyalgi).
- Mere end 50 mg morfinækvivalent dagligt opioidbrug.
- Aktiv bakteriel infektion eller behandling af infektion med antibiotika inden for de seneste 4 uger.
- Medicinske tilstande, der forårsager betydelig funktionsnedsættelse (f.eks. slagtilfælde, KOL).
- Vanedannende adfærd, svær klinisk depression eller psykotiske træk.
- Anamnese med anafylaktisk reaktion på enhver anvendt medicin.
- Dem, der modtager vederlag for deres smertebehandling (f.eks. handicap, arbejdsskadeerstatning).
- De involverede i aktive retssager, der er relevante for deres smerte.
- Deltageren er fængslet.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Nimbus Sacroiliac Joint Radiofrekvensablation (N-SIJRFA)
N-SIJRFA - ved at bruge en bipolar "palisade"-teknik til at skabe en kontinuerlig strimmellæsion.
|
|
|
Aktiv komparator: Konventionel sacroiliac joint radiofrekvensablation (C-SIJRFA)
C-SIJRFA - ved brug af konventionel monopolær periforaminal teknik
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Numeric Pain Rating Score
Tidsramme: 3 month
|
The number of participants with ≥50% change in their Numeric Pain Rating Scale (NPRS) pain score at the 3-month follow-up assessment. The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. |
3 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
EQ-5D forbedring
Tidsramme: 24 måneder
|
Andelen af patienter med klinisk signifikant forbedring i det kategoriske EuroQol 5 Dimensions-værktøj (EQ-5D) (20) defineret ved ≥0,03 efter behandlinger
|
24 måneder
|
|
Percent of Relief Using the Numeric Pain Rating Scale
Tidsramme: 6 month
|
The number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale (NPRS) The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. |
6 month
|
|
Percent of Relief Using the Numeric Pain Rating Scale
Tidsramme: 12 month
|
The number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. |
12 month
|
|
Percent of Relief Using the Numeric Pain Rating Scale
Tidsramme: 18 month
|
The percentage of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. |
18 month
|
|
Percent of Relief Using the Numeric Pain Rating Scale. NOTE: The Study Ended Before Month 24 Data Could be Gathered.
Tidsramme: 24 month
|
The number of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. |
24 month
|
|
Oswestry Disability Index (ODI) Reduction
Tidsramme: 3 month
|
The number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
|
3 month
|
|
Oswestry Disability Index (ODI) Reduction
Tidsramme: 6 month
|
The number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
|
6 month
|
|
Oswestry Disability Index (ODI) Reduction
Tidsramme: 12 month
|
The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
|
12 month
|
|
Oswestry Disability Index (ODI) Reduction
Tidsramme: 18 month
|
The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
|
18 month
|
|
Oswestry Disability Index (ODI) Reduction NOTE: The Study Ended Before Month 24 Data Could be Gathered.
Tidsramme: 24 month
|
The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. NOTE: The study ended before month 24 data could be gathered.
Interpretation of ODI Scores:
|
24 month
|
|
EQ-5D Improvement
Tidsramme: 3 month
|
The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
|
3 month
|
|
EQ-5D Improvement
Tidsramme: 6 month
|
The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
|
6 month
|
|
EQ-5D Improvement
Tidsramme: 12 month
|
The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
|
12 month
|
|
EQ-5D Improvement
Tidsramme: 18 month
|
The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
|
18 month
|
|
Patient Global Impression of Change (PGIC) Improvement
Tidsramme: 3 month
|
The number of participants who report being "improved" or "much improved" on the PGIC scale
|
3 month
|
|
PGIC Improvement
Tidsramme: 6 month
|
The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
|
6 month
|
|
PGIC Improvement
Tidsramme: 12 month
|
The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
|
12 month
|
|
PGIC Improvement
Tidsramme: 18 month
|
The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
|
18 month
|
|
PGIC Improvement NOTE: The Study Ended Before Month 24 Data Could be Gathered.
Tidsramme: 24 month
|
The proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
|
24 month
|
|
The Pain and Sleep Questionnaire Three-item Index (PSQ-3)
Tidsramme: 3 Months
|
The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. |
3 Months
|
|
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
Tidsramme: 6 Months
|
The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. |
6 Months
|
|
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
Tidsramme: 12 Months
|
The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. |
12 Months
|
|
The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
Tidsramme: 18 Months
|
The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. |
18 Months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
- Roberts SL, Burnham RS, Ravichandiran K, Agur AM, Loh EY. Cadaveric study of sacroiliac joint innervation: implications for diagnostic blocks and radiofrequency ablation. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):456-64. doi: 10.1097/AAP.0000000000000156.
- SOLONEN KA. The sacroiliac joint in the light of anatomical, roentgenological and clinical studies. Acta Orthop Scand Suppl. 1957;27:1-127. No abstract available.
- Bradley KC. The anatomy of backache. Aust N Z J Surg. 1974 Jul;44(3):227-32. doi: 10.1111/j.1445-2197.1974.tb04409.x. No abstract available.
- Roberts SL, Stout A, Loh EY, Swain N, Dreyfuss P, Agur AM. Anatomical Comparison of Radiofrequency Ablation Techniques for Sacroiliac Joint Pain. Pain Med. 2018 Oct 1;19(10):1924-1943. doi: 10.1093/pm/pnx329.
- Shih CL, Shen PC, Lu CC, Liu ZM, Tien YC, Huang PJ, Chou SH. A comparison of efficacy among different radiofrequency ablation techniques for the treatment of lumbar facet joint and sacroiliac joint pain: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2020 Aug;195:105854. doi: 10.1016/j.clineuro.2020.105854. Epub 2020 Apr 19.
- Sahoo RK, Das G, Pathak L, Dutta D, Roy C, Bhatia A. Cryoneurolysis of Innervation to Sacroiliac Joints: Technical Description and Initial Results-A Case Series. A A Pract. 2021 Mar 30;15(4):e01427. doi: 10.1213/XAA.0000000000001427.
- Nouer Frederico T, Ferraro LHC, Lemos JD, Sakata RK. Chemical neurolysis of the lateral branches of the sacral dorsal rami for the treatment of chronic pain in the sacroiliac joint: Case report and description of the technique. Pain Pract. 2022 Jan;22(1):134-136. doi: 10.1111/papr.13046. Epub 2021 Jun 25. No abstract available.
- Ibrahim R, Telfeian AE, Gohlke K, Decker O. Endoscopic Radiofrequency Treatment of the Sacroiliac Joint Complex for Low Back Pain: A Prospective Study with a 2-Year Follow-Up. Pain Physician. 2019 Mar;22(2):E111-E118.
- Najafi A, Sartoretti E, Binkert CA. Sacroiliac Joint Ablation Using MR-HIFU. Cardiovasc Intervent Radiol. 2019 Sep;42(9):1363-1365. doi: 10.1007/s00270-019-02263-0. Epub 2019 Jun 11.
- Bogduk N. Commentary on King W, Ahmed S, Baisden J, Patel N, MacVicar J, Kennedy DJ. Diagnosis of posterior sacroiliac complex pain: a systematic review with comprehensive analysis of the published data. Pain Med. 2015 Feb;16(2):222-4. doi: 10.1111/pme.12615. Epub 2014 Nov 5. No abstract available.
- Cohen SP, Strassels SA, Kurihara C, Crooks MT, Erdek MA, Forsythe A, Marcuson M. Outcome predictors for sacroiliac joint (lateral branch) radiofrequency denervation. Reg Anesth Pain Med. 2009 May-Jun;34(3):206-14. doi: 10.1097/AAP.0b013e3181958f4b.
- Tinnirello A, Barbieri S, Todeschini M, Marchesini M. Conventional (Simplicity III) and Cooled (SInergy) Radiofrequency for Sacroiliac Joint Denervation: One-Year Retrospective Study Comparing Two Devices. Pain Med. 2017 Sep 1;18(9):1731-1744. doi: 10.1093/pm/pnw333.
- Cheng J, Pope JE, Dalton JE, Cheng O, Bensitel A. Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. Clin J Pain. 2013 Feb;29(2):132-7. doi: 10.1097/AJP.0b013e3182490a17.
- Speldewinde GC. Successful Thermal Neurotomy of the Painful Sacroiliac Ligament/Joint Complex-A Comparison of Two Techniques. Pain Med. 2020 Mar 1;21(3):561-569. doi: 10.1093/pm/pnz282.
- Bogduk N. On the Rational Use of Diagnostic Blocks for Spinal Pain. Neurosurg Q. 2009 Jun;19(2):88-100.
- Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.
- Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.
- Soer R, Reneman MF, Speijer BL, Coppes MH, Vroomen PC. Clinimetric properties of the EuroQol-5D in patients with chronic low back pain. Spine J. 2012 Nov;12(11):1035-9. doi: 10.1016/j.spinee.2012.10.030.
- Ayearst L, Harsanyi Z, Michalko KJ. The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies. Pain Res Manag. 2012 Jul-Aug;17(4):281-90. doi: 10.1155/2012/635967.
- Tonosu J, Oka H, Watanabe K, Abe H, Higashikawa A, Kawai T, Yamada K, Nakarai H, Tanaka S, Matsudaira K. Characteristics of the spinopelvic parameters of patients with sacroiliac joint pain. Sci Rep. 2021 Mar 4;11(1):5189. doi: 10.1038/s41598-021-84737-1.
- Tonosu J, Kurosawa D, Nishi T, Ito K, Morimoto D, Musha Y, Ozawa H, Murakami E. The association between sacroiliac joint-related pain following lumbar spine surgery and spinopelvic parameters: a prospective multicenter study. Eur Spine J. 2019 Jul;28(7):1603-1609. doi: 10.1007/s00586-019-05952-z. Epub 2019 Mar 18.
- GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB 150067
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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
-
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
-
National Taiwan University HospitalBuddhist Tzu Chi General Hospital; Taipei Medical University Hospital; E-DA... og andre samarbejdspartnereUkendtKoloskopi | Udrensning af tyktarm | Low-Reside diætTaiwan
-
Medical College of WisconsinChildren's WisconsinAktiv, ikke rekrutterendeSimulering af fysisk sygdom | Trakeostomi komplikation | Teach-back kommunikationForenede Stater
-
Marmara UniversityAfsluttetTeach-back kommunikationTyrkiet (Türkiye)
-
Otsuka Pharmaceutical Co., Ltd.AfsluttetHyper-low-density Lipoprotein (LDL) KolesterolæmiJapan
-
Tyra Biosciences, IncRekrutteringLow Grade Upper Tract Urothelial CarcinomaForenede Stater
-
Otsuka Pharmaceutical Co., Ltd.AfsluttetHyper-low-density Lipoprotein (LDL) KolesterolæmiJapan