Aging Successfully With Pain

NCT01405716 | Completed DMC

• 2 other identifiers: PRO09100150R01AG034078-01
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Keywords

Mindfulness; Back Pain; Older adults

Outcome Measures

Primary Outcomes (1)

• Change in the Roland-Morris Questionnaire

  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

Study Arms (2)

Behavioral-Mindfulness

ACTIVE COMPARATOR

Mindfulness Meditation

Behavioral: Mindfulness Meditation

Behavioral-Health

PLACEBO COMPARATOR

Health Education Class

Behavioral: Health Education

Interventions

Mindfulness Meditation BEHAVIORAL

8-week mindfulness based program will be compared to and education control group

Behavioral-Mindfulness

Health Education BEHAVIORAL

8-week health education program

Behavioral-Health

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years or older
• Have intact cognition (Mini-Mental Status Exam (MMSE) \>24)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 26903081 DERIVED

• 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.

  PMID: 22115971 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dr Natalia Morone, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 29, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: October 3, 2017

Record last verified: 2017-09

Locations

US (1)