- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02038244
Integrative Medicine for Chronic Pain (POSITIVE)
Integrative Medicine for Chronic Pain - Process-Outcome-Study in the Context of an Internal Medicine Ward for Integrative Medicine
In this study, the effects of a 14-day inpatient treatment in an internal medicine ward for integrative medicine on pain, disability, quality of life, satisfaction with life, depression, and anxiety will be investigated. Furthermore the influence of potential process variables will be evaluated.
Effects will be measured after completion of the program (2 weeks), and at 6 months follow up after start of the program.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Essen, Tyskland
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- diagnosed with any chronic pain condition
- at least 6 months pain duration
- written informed consent
Exclusion Criteria:
- participation in any other clinical study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Integrative Medicine
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: 14 days
|
VAS
|
14 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity
Tidsramme: 6 months
|
VAS
|
6 months
|
|
Pain Disability
Tidsramme: 14 days, 6 months
|
- German Pain Questionnaire
|
14 days, 6 months
|
|
Health-related quality of life
Tidsramme: 14 days, 6 months
|
Short Form (36) Health Survey
|
14 days, 6 months
|
|
Life satisfaction
Tidsramme: 14 days, 6 months
|
Brief Multidimensional Life Satisfaction Scale
|
14 days, 6 months
|
|
Depression
Tidsramme: 14 days, 6 months
|
Beck Depression Inventory
|
14 days, 6 months
|
|
Acceptance
Tidsramme: 14 days, 6 months
|
Emotional/Rational Disease Acceptance Questionnaire
|
14 days, 6 months
|
|
Mindfulness
Tidsramme: 14 days, 6 months
|
Conscious Presence and Self Control (CPSC) Scale
|
14 days, 6 months
|
|
Subjective stress
Tidsramme: 14 days, 6 months
|
Perceived Stress Scale
|
14 days, 6 months
|
|
Easiness of life
Tidsramme: 14 days, 6 months
|
Questionnaire on emotional and physical reactions
|
14 days, 6 months
|
|
Ability and will to change
Tidsramme: 14 days, 6 months
|
Ability and will to change Questionnaire
|
14 days, 6 months
|
|
Safety
Tidsramme: 14 days, 6 months
|
Adverse events
|
14 days, 6 months
|
|
Pain Disability
Tidsramme: 14 days, 6 months
|
- Pain Disability Index
|
14 days, 6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Body awareness
Tidsramme: 14 days, 6 months
|
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Body Awareness Questionnaire (BAQ) (Shields 1989) |
14 days, 6 months
|
|
Body responsiveness
Tidsramme: 14 days, 6 months
|
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes.
|
14 days, 6 months
|
|
Body awareness and dissociation
Tidsramme: 14 days, 6 months
|
Translated body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Scale of Body Connection (SBC) (Price and Thompson 2007) |
14 days, 6 months
|
|
Postural awareness
Tidsramme: 14 days, 6 months
|
Newly developed body awareness questionnaire will be validated. It will further be used for mediation and moderator analysis with the outcomes. - Postural Awareness Scale (PAS) (Cramer et al.) |
14 days, 6 months
|
|
Body awareness
Tidsramme: 14 days, 6 months
|
The DKB will be used for mediation and moderator analysis with the outcomes and for validation purposes. - Dresden Body Image Questionnaire (DKB) (Pöhlmann et al., 2007) |
14 days, 6 months
|
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Daily log
Tidsramme: 2 weeks
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Daily rating of pain and well-being on a 100mm visual analog scale.
|
2 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 135393-BO
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 .
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