- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01405716
Aging Successfully With Pain
30. september 2017 oppdatert av: Natalia Morone, University of Pittsburgh
Effectiveness of a Mind-Body Program for Older Adults With Chronic Low Back Pain
The primary objective of this study is to determine the effectiveness of a mind-body program in increasing function and reducing pain among older adults with chronic low back pain
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Among mind-body therapies, there is evidence for an association between pain reduction and mindfulness meditation.
Mindfulness meditation provides a potentially safe, effective, nonpharmacologic, noninvasive, simple method for pain relief and increased function that could be used for the frailest older adult.
This experimental study is designed as a randomized, education controlled clinical trial of a mind-body program for older adults with chronic low back pain.
A sample of 300 independent, community-dwelling adults 65 years of age and older will be recruited.
After determining eligibility, study participants will give written informed consent and will be randomized to either the mindfulness-based stress reduction (MBSR) program or the health education control program.
Participants in the mind-body group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions that are modeled on the MBSR program.
Controls will receive an 8-week health education program based on the 10 Keys(TM) to Healthy Aging.
After completion of the 8-week program, participants in both programs will be asked to return for 12 monthly booster sessions.
Prior to initiating the program, immediately after the last program session, and 6 & 12 months later, the following parameters will be assessed: (1) physical function, (2) pain severity, (3) neuropsychological performance, (4) measures of mindfulness, (5) demographic factors, and (6) biomedical factors.
Studietype
Intervensjonell
Registrering (Faktiske)
282
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh
-
-
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
61 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 65 years or older
- Have intact cognition (Mini-Mental Status Exam (MMSE) >24)
- 65 years of age or older.
- Have functional limitations due to their low back, defined as a score of at least 12 on the Roland and Morris Disability Questionnaire.
- CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months.
- Speak English.
Exclusion Criteria:
- Do not meet the above inclusion criteria
- Have previously participated in a mindfulness meditation program.
- Have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain.
- Are non-ambulatory, or have severely impaired mobility (i.e., require the use of a walker): since measurement of physical performance in the proposed study includes timed chair rise, gait velocity, and standing balance, conditions other than back pain that could negatively impact these measures may confound our study results.
- Have severe visual or hearing impairment: since this study will involve questionnaires and telephone evaluations, severe visual and/or hearing impairments may interfere with data collection and data validity. For example, the Mini-Mental Status Exam has never been validated in those with severe visual or hearing disturbance.
- Have pain in other parts of the body that is more severe than their low back pain, [defined as pain other than in the lower back that occurs daily or almost every day and is of at least moderate intensity] or acute back pain: since we will be specifically evaluating chronic low back pain, we do not want to confound the outcome data with [significant pain] from other areas or with acute pain. Thus only participants with chronic low back pain severity that is greater than pain severity elsewhere in the body will be included.
- Have acute or terminal illness: To insure weekly participation and a twelve month follow-up, participants with an acute or terminal illness will be excluded from the study.
- Have moderate to severe depression, defined as a Geriatric Depression Scale score of 21 and above: since active depression may affect the psychological outcomes of the study and may affect compliance with participation in the intervention and control programs.
- Do not have access to a telephone: since monthly assessments will be done over the telephone.
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Behavioral-Mindfulness
Mindfulness Meditation
|
8-week mindfulness based program will be compared to and education control group
|
|
Placebo komparator: Behavioral-Health
Health Education Class
|
8-week health education program
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Roland-Morris Questionnaire
Tidsramme: Change from Baseline to 8-weeks to 6-months to 12-months
|
The Roland-Morris Questionnaire is a disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain
|
Change from Baseline to 8-weeks to 6-months to 12-months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dr Natalia Morone, MD, MS, University of Pittsburgh
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.
- Morone NE, Greco CM, Rollman BL, Moore CG, Lane B, Morrow L, Glynn NW, Delaney J, Albert SM, Weiner DK. The design and methods of the aging successfully with pain study. Contemp Clin Trials. 2012 Mar;33(2):417-25. doi: 10.1016/j.cct.2011.11.012. Epub 2011 Nov 15.
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. februar 2011
Primær fullføring (Faktiske)
1. september 2014
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
25. juli 2011
Først innsendt som oppfylte QC-kriteriene
28. juli 2011
Først lagt ut (Anslag)
29. juli 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. september 2017
Sist bekreftet
1. september 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO09100150
- R01AG034078-01 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .