Alvorlig kronisk nevropatisk smerte: En behandlingspakke, med bruk av ryggmargstimulering og tverrfaglig behandling, for å redusere smerte og forbedre fysisk funksjon. (SCS-R)
Optimalisering av behandling for kronisk nevropatisk smerte: En replikert enkeltsakseksperimentell design som evaluerer en behandlingspakke bestående av tverrfaglig rehabilitering og ryggmargsstimulering (SCS-R)
Personer med nerveskade kan utvikle nervesmerter. Smertene kan noen ganger være alvorlige og uforutsigbare, og forårsake merkelige eller alarmerende følelser - for eksempel lynlignende eller elektriske støt-følelser i området som betjenes av den skadde nerve.
Vi vil undersøke en behandling for nervesmerter i bena forårsaket av nerveskade, som kan oppstå etter en prolaps eller et brudd, med eller uten operasjon.
Tidligere forskning tyder på at ryggmargstimulering kan lindre nervesmerter i bena etter operasjon eller skade, men dens effektivitet er fortsatt omdiskutert. Andre studier viser at tverrfaglig behandling hjelper personer med langvarige smerter med å forbedre livskvaliteten sin og å takle livet bedre. Nasjonale og internasjonale retningslinjer anbefaler denne typen tverrfaglig behandling for langvarige smerter.
Ingen har ennå publisert forskning på ryggmargstimulering kombinert med tverrfaglig behandling som en pakkeintervensjon. Vi ønsker derfor å finne ut om denne kombinerte tilnærmingen kan redusere nervesmerter i bena og forbedre fysisk funksjon.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Single-case experimental design (SCED) with repeated measurements structured into phases is the method of this study.
Phase A1 is the pre-implantation baseline, Phase A2 is waiting time from implantation to start of the intervention (SCS+rehabilitation). Length of A2 is randomized (2-4 weeks).
Phase B is the active SCS+rehabilitation intervention and lasts for 12 weeks (for analysis split into an early B1 (week 1-5) and a later B2 period (week 8-12), and FU is the 5 week follow-up approximately 6 months after implantation.
Outcomes are measured repeatedly within these phases, allowing within-patient phase contrasts.
In general, baseline (A1) is compared with the intervention periods (B1 and B2) and with follow-up (FU). The main pre-specified contrasts for the primary outcomes are:
- For leg pain intensity A1 vs B1 is the primary comparison and A1 vs B2 is secondary, with A1 vs FU and B2 vs FU reported descriptively.
- For physical function (PROMIS-29), A1 vs B2 is the primary comparison as onset of rehabilitation effect is expected to be delayed. A1 vs B1 is exploratory, with A1 vs FU and B2 vs FU reported descriptively.
Other repeated-measures outcomes (PROMIS-29 domains and additional NRS/physical activity measures) follow the same structure, with A1 vs B2 generally defined as secondary and A1 vs FU descriptive as shown in the statistical tables
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Christopher Ekholdt, PhD-student
- Telefonnummer: +4723026161
- E-post: chrekh@ous-hf.no
Studer Kontakt Backup
- Navn: Lars-Petter Granan, Ph.D
- Telefonnummer: +4723026161
- E-post: largra@ous-hf.no
Studiesteder
-
-
-
Oslo, Norge
- Rekruttering
- Department of pain management and research, Oslo university hospital
-
Ta kontakt med:
- Lars-Petter Granan, Ph.D
- Telefonnummer: +4723026161
- E-post: largra@ous-hf.no
-
Ta kontakt med:
- Christopher Ekholdt, Ph.D-student
- Telefonnummer: +4723026161
- E-post: chrekh@ous-hf.no
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
Perifer nevropatisk smerte i ett eller begge ben i >6 måneder på grunn av:
- (1) Postspinalt smertesyndrom (type 1 eller 2).
- (2) Lokalisert nerveskade.
- Området med nevropatisk smerte i benet/benene må være den dominerende smertedelen.
- Alder mellom 18–60 år.
- Tidligere standard konservativ (eller kirurgisk) behandling forsøkt.
- Opioidbruk innenfor tillatte grenser ved implantasjonstidspunkt (daglig opioiddose <50 mg OMEQ).
- Villighet til å delta aktivt i behandlingspakken.
- Bor innen rimelig reiseavstand fra Oslo.
- God forståelse av muntlig og skriftlig norsk, nødvendig for å dra nytte av programmet som er avhengig av gjensidig forståelse, nyanserte samtaler og følelsesmessig uttrykk, som er språkavhengige.
- Kognitiv evne til å gi informert samtykke.
- Evne til å mestre de tekniske aspektene av SCS-systemet (bytte programmer på fjernkontrollen).
Eksklusjonskriterier:
- Gjennomgår for tiden søknadsprosessen for helseytelser (f.eks. uførepensjon fra NAV (Arbeids- og velferdsetaten)).
- Har en psykologisk eller psykiatrisk lidelse som kan påvirke behandlingseffekten.
- Kroniske generaliserte smertetilstander.
- Andre smertetilstander i det berørte området, som artrose.
- Svangerskap.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Behandlingspakke
Behandlingspakke bestående av ryggmargstimulering samt tverrfaglig rehabilitering
|
Intervensjonen er en behandlingspakke som består av ryggmargstimulering pluss tverrfaglig rehabilitering.
Den tverrfaglige rehabiliteringen består av treningsbehandling, kognitiv terapi og individuell programmering av SCS-enheten.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity in leg(s)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for leg pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) . |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Physical function (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using the PROMIS-29 Physical Function domain T-score (mean 50, SD 10 in the reference population).
Higher scores indicate better physical function.
MCID: increase of ≥5 T-score points.
Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .
|
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity in the lower back
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for lower back pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Pain interference (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using the PROMIS-29 Pain Interference domain T-score. Higher scores indicate more interference of pain with daily activities. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Pain intensity (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for pain intensity last 7 days in PROMIS-29, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Assessed at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Physical function (6-min-walk test)
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Functional walking capacity is assessed using the Six-Minute Walk Test (6MWT). Distance walked in 6 minutes on a flat course is recorded in meters; higher distances indicate better walking capacity. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Physical function (sit-to-stand test)
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Lower limb functional strength and endurance are assessed with a Sit-to-Stand Test, recorded as number of repetitions in a fixed time.
More repetitions indicate better performance.
Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
|
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Physical function (stair test)
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Functional mobility is assessed using a Stair test (ST; time to climb 18 stairs 3 times; lower times indicate better function). Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Physical activity (MET-minutes per week)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Physical activity is assessed as metabolic equivalent (MET) minutes per week, calculated from reported frequency and duration of activities (International Physical Activity Questionnaire (IPAQ)). Higher values indicate greater weekly physical activity. Assessed once per week during baseline (A1), SCS+rehabilitation (B1/B2), and follow-up (FU) within the single-case experimental design. |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Health-related quality of life (EQ-5D index)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
EQ-5D-5L index score (range 0-1; higher scores indicate better health-related quality of life). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Health-related quality of life (EQ-5D-5L VAS)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
EQ-5D Visual Analogue Scale (EQ-5D VAS; 0-100; higher scores indicate better health-related quality of life). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Depression symptoms (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
PROMIS Depression scale (T-score; mean 50, SD 10 in U.S. population; higher scores indicate greater symptom severity).
Improvement is defined as a decrease of ≥5 T-score points (MCID).
Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
|
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Social participation (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
PROMIS Ability to Participate in Social Roles and Activities short form, reported as a T-score (higher scores indicate better function). MCID: increase of ≥5 T-score points. Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Fatigue (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using the PROMIS-29 Fatigue domain T-score. Higher scores indicate greater fatigue. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Sleep disturbance (PROMIS-29)
Tidsramme: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
Assessed using the PROMIS-29 Sleep Disturbance domain T-score. Higher scores indicate more sleep problems. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
|
|
Opioid and Analgesic Use
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Total opioid consumption quantified as milligrams of oral morphine equivalents (OMEQ) per day; non-opioid analgesics quantified in milligrams per day per medication. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Return to work
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Return to work status, quantified as hours worked per week (higher values indicate greater work participation). Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Fear of movement (Tampa Scale)
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Fear of movement is assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores indicate greater fear of movement. Improvement is defined as a decrease of >6 points. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Patient-specific functioning
Tidsramme: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Patient-Specific Functional Scale (PSFS), up to five activities selected in cooperation with personnel, rated 0-10 (higher scores indicate better function; average score reported). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
|
Patient satisfaction
Tidsramme: End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved").
|
End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Lars-Petter Granan, Ph.D, Department of pain management and research, Oslo university hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Nevromuskulære sykdommer
- Sykdommer i det perifere nervesystemet
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Nevralgi
- Terapeutikk
- Pasientbehandling
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Atferdsterapi
- Psykoterapi
- Atferdsdisipliner og aktiviteter
- Ettervern
- Kontinuitet i pasientbehandling
- Elektrisk stimuleringsbehandling
- Kognitiv atferdsterapi
- Aksept og forpliktelsesbehandling
- Rehabilitering
- Fysioterapi -modaliteter
- Ryggmargsstimulering
Andre studie-ID-numre
- 942321
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Individuelle deltakerdata for alle innsamlede variabler, generert under studien og fullstendig dokumentert i en medfølgende datatolkning (som detaljerer variabelnavn, koder, verdier, enheter og avledninger), vil bli tilgjengeliggjort etter rimelig forespørsel fra kvalifiserte forskere etter publisering. Tilgang vil bli begrenset til kvalifiserte forskere som sender inn en søknad og får godkjenning fra relevant etisk komité og databeskyttelsesmyndighet.
Direkte og indirekte identifikatorer – inkludert navn, eksakte datoer og andre re-identifiseringsrisikoer – vil bli systematisk fjernet eller transformert (som for eksempel indeksjustering av datoer for å beholde intervaller mens kobling forhindres), noe som sikrer at datasettet støtter robuste sekundæranalyser samtidig som deltakernes personvern opprettholdes.
Studieprotokollen er planlagt publisert.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .