- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02561676
Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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New Jersey
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West Orange, New Jersey, États-Unis, 07052
- Kessler Foundation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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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Expérimental: 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.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Délai: 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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in pain intensity rated on a 0-10 numerical rating scale
Délai: 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
Délai: 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.
|
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
Délai: 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
Délai: 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.
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
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Change in Coping Strategies Questionnaire scores
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jeanne M Zanca, PhD, MPT, Kessler Foundation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R-860-14
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