Svår kronisk neuropatisk smärta: En behandlingspaket, med ryggmärgsstimulering och multidisciplinär behandling, för att minska smärta och förbättra fysisk funktion. (SCS-R)
Optimering av behandling för kronisk neuropatisk smärta: En replikerad experimentell enfallsdesign som utvärderar ett behandlingspaket bestående av multidisciplinär rehabilitering och ryggmärgsstimulering (SCS-R)
Personer med nervskador kan utveckla nervsmärta. Smärtan kan ibland vara svår och oförutsägbar, vilket orsakar konstiga eller oroande känslor - till exempel blixtliknande eller elektriska stötkänslor i området som betjänas av den skadade nerven.
Vi kommer att undersöka en behandling för nervsmärta i benen orsakad av nervskador, vilket kan uppstå efter en diskbråck eller ett benbrott, med eller utan operation.
Tidigare forskning tyder på att ryggmärgsstimulering kan lindra nervsmärta i benen efter operation eller skada, men dess effektivitet är fortfarande omdebatterad. Andra studier visar att multidisciplinär behandling hjälper personer med långvarig smärta att förbättra sin livskvalitet och att bättre klara sig i livet. Nationella och internationella riktlinjer rekommenderar denna typ av multidisciplinär vård för långvarig smärta.
Ingen har ännu publicerat forskning om ryggmärgsstimulering kombinerat med multidisciplinär behandling som ett paketerat ingrepp. Vi vill därför ta reda på om detta kombinerade tillvägagångssätt kan minska nervsmärta i benen och förbättra den fysiska funktionen.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Christopher Ekholdt, PhD-student
- Telefonnummer: +4723026161
- E-post: chrekh@ous-hf.no
Studera Kontakt Backup
- Namn: Lars-Petter Granan, Ph.D
- Telefonnummer: +4723026161
- E-post: largra@ous-hf.no
Studieorter
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Oslo, Norge
- Rekrytering
- Department of pain management and research, Oslo university hospital
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Kontakt:
- Lars-Petter Granan, Ph.D
- Telefonnummer: +4723026161
- E-post: largra@ous-hf.no
-
Kontakt:
- Christopher Ekholdt, Ph.D-student
- Telefonnummer: +4723026161
- E-post: chrekh@ous-hf.no
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
Perifer neuropatisk smärta i ett eller båda benen i >6 månader på grund av:
- (1) Postspinalt smärtsyndrom (typ 1 eller 2).
- (2) Lokaliserad nervskada.
- Området för den neuropatiska smärtan i benen måste vara den dominerande smärtkomponenten.
- Ålder mellan 18-60 år.
- Tidigare standard konservativ (eller kirurgisk) behandling har prövats.
- Opioidanvändning inom tillåtna gränser vid implantationstillfället (daglig opioiddos <50 mg OMEQ).
- Beredvillighet att aktivt delta i behandlingspaketet.
- Bor inom rimligt resavstånd från Oslo.
- Behärskar muntlig och skriftlig norska, vilket är avgörande för att dra nytta av programmet som bygger på ömsesidig förståelse, nyanserade samtal och känslouttryck, vilket är språkberoende.
- Kognitiv förmåga att ge informerat samtycke.
- Förmåga att behärska de tekniska aspekterna av SCS-systemet (byta program på fjärrkontrollen).
Exklusionskriterier:
- För närvarande genomgår ansökningsprocessen för hälsoförmåner (t.ex. sjukpension från NAV (Arbeids- og velferdsetaten)).
- Har en psykologisk eller psykiatrisk störning som kan påverka behandlingseffekten.
- Kroniska generaliserade smärttillstånd.
- Andra smärttillstånd i det drabbade området, som artros.
- Graviditet.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Behandlingspaket
Behandlingspaket bestående av ryggmärgsstimulering plus multidisciplinär rehabilitering
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Ingripandet är ett behandlingspaket som består av ryggmärgsstimulering plus multidisciplinär rehabilitering.
Den multidisciplinära rehabiliteringen består av träningsbehandling, kognitiv terapi och individualiserad programmering av SCS-enheten.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain intensity in leg(s)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Physical function (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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) .
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From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pain intensity in the lower back
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Pain interference (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Pain intensity (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Physical function (6-min-walk test)
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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.
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Physical function (sit-to-stand test)
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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).
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Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical function (stair test)
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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.
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Physical activity (MET-minutes per week)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Health-related quality of life (EQ-5D index)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Health-related quality of life (EQ-5D-5L VAS)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Depression symptoms (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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).
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From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Social participation (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Fatigue (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Sleep disturbance (PROMIS-29)
Tidsram: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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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.
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Opioid and Analgesic Use
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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.
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Return to work
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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.
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Fear of movement (Tampa Scale)
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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.
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Patient-specific functioning
Tidsram: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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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.
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Patient satisfaction
Tidsram: End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved").
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End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lars-Petter Granan, Ph.D, Department of pain management and research, Oslo university hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Neuromuskulära sjukdomar
- Sjukdomar i det perifera nervsystemet
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Neuralgi
- Terapeutik
- Patientvård
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Beteendebehandling
- Psykoterapi
- Beteendediscipliner och aktiviteter
- Eftervård
- Kontinuitet i patientvård
- Elektrisk stimuleringsterapi
- Kognitiv beteendeterapi
- Acceptans och engagemangsterapi
- Rehabilitering
- Fysioterapimetoder
- Ryggmärgsstimulering
Andra studie-ID-nummer
- 942321
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Individuella deltagardata för alla insamlade variabler, genererade under studien och fullständigt dokumenterade i ett tillhörande datalexikon (som specificerar variabelnamn, koder, värden, enheter och härledningar), kommer att göras tillgängliga vid rimlig begäran från kvalificerade forskare efter publicering. Tillgången kommer att begränsas till kvalificerade forskare som lämnar in en ansökan och får godkännande från relevant etikprövningsnämnd och dataskyddsmyndighet.
Direkta och indirekta identifierare – inklusive namn, exakta datum och andra reidentifieringsrisker – kommer att systematiskt tas bort eller omvandlas (t.ex. genom indexjustering av datum för att bevara intervall samtidigt som länkning förhindras), vilket säkerställer att datasetet stödjer robusta sekundäranalyser samtidigt som deltagarnas integritet upprätthålls.
Studieprotokollet planeras att publiceras.
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