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Aging Successfully With Pain

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ClinicalTrials.gov Identifier: NCT01405716
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Natalia Morone, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 29, 2011
Last Update Posted Date October 3, 2017
Study Start Date  ICMJE February 2011
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
Change in the Roland-Morris Questionnaire [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2011)
  • The Roland-Morris Questionnaire [ Time Frame: Baseline ]
    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
  • The Roland-Morris Questionnaire [ Time Frame: 8 weeks ]
    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
  • The Roland-Morris Questionnaire [ Time Frame: 6 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
  • The Roland-Morris Questionnaire [ Time Frame: 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 History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aging Successfully With Pain
Official Title  ICMJE Effectiveness of a Mind-Body Program for Older Adults With Chronic Low Back Pain
Brief Summary 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
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Behavioral: Mindfulness Meditation
    8-week mindfulness based program will be compared to and education control group
  • Behavioral: Health Education
    8-week health education program
Study Arms  ICMJE
  • Active Comparator: Behavioral-Mindfulness
    Mindfulness Meditation
    Intervention: Behavioral: Mindfulness Meditation
  • Placebo Comparator: Behavioral-Health
    Health Education Class
    Intervention: Behavioral: Health Education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
282
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2011)
300
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01405716
Other Study ID Numbers  ICMJE PRO09100150
R01AG034078-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Natalia Morone, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Dr Natalia Morone, MD, MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP