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

8 mei 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

75

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New Jersey
      • West Orange, New Jersey, Verenigde Staten, 07052
        • Kessler Foundation

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in pain intensity rated on a 0-10 numerical rating scale
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kessler Foundation

Medewerkers

eMindful.com

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2015

Primaire voltooiing (Werkelijk)

31 december 2018

Studie voltooiing (Werkelijk)

31 december 2019

Studieregistratiedata

Eerst ingediend

11 februari 2015

Eerst ingediend dat voldeed aan de QC-criteria

25 september 2015

Eerst geplaatst (Schatting)

28 september 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2020

Laatste update ingediend die voldeed aan QC-criteria

8 mei 2020

Laatst geverifieerd

1 mei 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • R-860-14

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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