Trial record 1 of 1 for:    NCT01405716
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Aging Successfully With Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01405716
First received: July 25, 2011
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention
Low Back Pain
Behavioral: Mindfulness Meditation
Behavioral: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Mind-Body Program for Older Adults With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The Roland-Morris Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: February 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Behavioral-Mindfulness
Mindfulness Meditation
Behavioral: Mindfulness Meditation
8-week mindfulness based program will be compared to and education control group
Placebo Comparator: Behavioral-Health
Health Education Class
Behavioral: Health Education
8-week health education program

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405716

Contacts
Contact: Bridget Lane, MS 412-586-9817 laneb@upmc.edu
Contact: Jill Delaney, BSW 412-692-2013 delaneyjf2@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Bridget Lane, MS    412-586-9817    laneb@upmc.edu   
Principal Investigator: Dr. Natalia Morone, MD, MS         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dr Natalia Morone, MD, MS University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Natalia Morone, MD, MS, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01405716     History of Changes
Other Study ID Numbers: PRO09100150, RO1AG034078-01
Study First Received: July 25, 2011
Last Updated: July 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Mindfulness
Back Pain
Older adults

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014