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Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education

8. Mai 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

75

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New Jersey
      • West Orange, New Jersey, Vereinigte Staaten, 07052
        • Kessler Foundation

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Education Program Type 1
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.
Experimental: 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.
Sonstiges: Education Program Type 2
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Zeitfenster: 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)
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.
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in pain intensity rated on a 0-10 numerical rating scale
Zeitfenster: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Brief Patient Health Questionnaire scores
Zeitfenster: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Brief Patient Health Questionnaire will be used to assess changes in mental health before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Mental Health Subscale of the SF-36 scores
Zeitfenster: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Survey of Pain Attitudes scores
Zeitfenster: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Survey of Pain Attitudes will be used to assess thoughts and feelings about pain before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Coping Strategies Questionnaire scores
Zeitfenster: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Coping Strategies Questionnaire will be used to assess thoughts and feelings about pain before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Change in Chronic Pain Acceptance Questionnaire scores
Zeitfenster: Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
The Chronic Pain Acceptance Questionnaire will be used to assess thoughts and beliefs about pain before and after participation in the education program.
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Kessler Foundation

Mitarbeiter

eMindful.com

Ermittler

  • Hauptermittler: Jeanne M Zanca, PhD, MPT, Kessler Foundation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2015

Primärer Abschluss (Tatsächlich)

31. Dezember 2018

Studienabschluss (Tatsächlich)

31. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

11. Februar 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. September 2015

Zuerst gepostet (Schätzen)

28. September 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Mai 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Mai 2020

Zuletzt verifiziert

1. Mai 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R-860-14

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