Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
8. mai 2020 oppdatert av: Kessler Foundation
Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI).
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic pain (pain that is present for a long period of time) is common among people with spinal cord injury (SCI). The pain is often severe and can affect daily activities. Unfortunately, common treatments such as medications provide incomplete relief from chronic pain. Thus, persons with SCI have to find alternate ways to live a happy, healthy, and productive life, even with some pain.
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
Studietype
Intervensjonell
Registrering (Faktiske)
75
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Jersey
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West Orange, New Jersey, Forente stater, 07052
- Kessler Foundation
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- SCI for at least one year
- Chronic pain for at least three months that is moderate to severe
- Fluent in English
- Not currently starting a new pain treatment or changing a previous pain treatment
Exclusion Criteria:
- Lack of access to a computer with high-speed internet access, at home or another location
- Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect physical or mental functioning
- Significant difficulties with learning or memory
- Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
- Inability to understand English well
- Other conditions not related to SCI that cause pain (such as fibromyalgia)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Web-Based Education Program Type 1
The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.
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The classes will discuss topics related to health and functioning of people with spinal cord injury.
During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group.
Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
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Eksperimentell: Web-Based Education Program Type 2
The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.
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The classes will discuss topics related to health and functioning of people with spinal cord injury.
During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group.
Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Tidsramme: Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
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The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS).
The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life.
The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
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Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in pain intensity rated on a 0-10 numerical rating scale
Tidsramme: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
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Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Change in Brief Patient Health Questionnaire scores
Tidsramme: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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The Brief Patient Health Questionnaire will be used to assess changes in mental health before and after participation in the education program.
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Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Change in Mental Health Subscale of the SF-36 scores
Tidsramme: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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The Mental Health Subscale of the SF-36 will be used to assess changes in mental health and well-being before and after participation in the education program.
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Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Change in Survey of Pain Attitudes scores
Tidsramme: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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The Survey of Pain Attitudes will be used to assess thoughts and feelings about pain before and after participation in the education program.
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Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Change in Coping Strategies Questionnaire scores
Tidsramme: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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The Coping Strategies Questionnaire will be used to assess thoughts and feelings about pain before and after participation in the education program.
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Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Change in Chronic Pain Acceptance Questionnaire scores
Tidsramme: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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The Chronic Pain Acceptance Questionnaire will be used to assess thoughts and beliefs about pain before and after participation in the education program.
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Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
Tidsramme: 3, 6, 12 months post-intervention versus baseline
|
The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS).
The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life.
The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
|
3, 6, 12 months post-intervention versus baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jeanne M Zanca, PhD, MPT, Kessler Foundation
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2015
Primær fullføring (Faktiske)
31. desember 2018
Studiet fullført (Faktiske)
31. desember 2019
Datoer for studieregistrering
Først innsendt
11. februar 2015
Først innsendt som oppfylte QC-kriteriene
25. september 2015
Først lagt ut (Anslag)
28. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. mai 2020
Sist bekreftet
1. mai 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R-860-14
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