- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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New Jersey
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West Orange, New Jersey, Stati Uniti, 07052
- Kessler Foundation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change in pain intensity rated on a 0-10 numerical rating scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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3, 6, 12 months post-intervention versus baseline
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jeanne M Zanca, PhD, MPT, Kessler Foundation
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R-860-14
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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