Mindfulness Meditation for Chronic Low Back Pain in Older Adults

NCT00494845 | Completed Phase 3 DMC

• 2 other identifiers: PRO07020074UL1RR024153
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. Additionally, mindfulness meditation addresses the multiple dimensions that are affected by chronic pain. The primary objective of this study is to determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in community dwelling older adults with chronic low back pain. Using a randomized controlled experimental design, 80 community dwelling older adults ≥ age 65 with chronic low back pain will receive either (1) the MBSR program, or (2) an 8-week education program. Prior to initiating the program, immediately after the last program session, and 6 months later, the following parameters will be assessed: (1) pain severity, (2) disability/physical function, (3) objectively measured physical performance, (4) psychosocial function (including mood, self-efficacy, self-rated health, coping, stress, quality of life (QOL), mindfulness and pain-related fear), (5) sleep, (6) pain-related appetite reduction and, (7) time and frequency of meditation. All measures are self-report except for the physical performance measure.

Conditions

Low Back Pain

Keywords

Mindfulness; Elderly; Chronic Illness; Back Pain; Chronic Low Back Pain; Older adults over the age of sixty-five; MMSE score of over 23; Speaks English

Outcome Measures

Primary Outcomes (3)

• Determine the impact of an 8-week mindfulness-based stress reduction program on physical function and pain severity in community dwelling older adults with chronic low back pain.

  One year

• Determine the impact of an 8-week mindfulness-based stress reduction program on psychosocial function, sleep, and appetite in older adults with chronic low back pain.

  One year

• Determine the impact of time and frequency of mindfulness meditation on physical function and pain severity.

  One year

Study Arms (2)

Intervention

EXPERIMENTAL

8-week Mindfulness Program for chronic low back pain

Behavioral: Mindfulness

Comparison

ACTIVE COMPARATOR

8-week health education program

Behavioral: Control: Health Education Class

Interventions

Mindfulness BEHAVIORAL

8-week mindfulness program will be compared to an education control group.

Intervention

Control: Health Education Class BEHAVIORAL

8-week education program

Comparison

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Have intact cognition (Mini-Mental Status Exam (MMSE) \>23)
• 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
• 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
• Significant pain in parts of the body other than the lower back or acute back pain: since we will be specifically evaluating chronic low back pain, we do not want to confound the outcome data with pain from other areas or with acute pain. Thus only subjects with chronic back pain severity that is greater than pain severity elsewhere in the body will be included
• Acute or terminal illness: To insure weekly participation and a six month follow-up, subjects with an acute or terminal illness will be excluded from the study.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Center for Research Resources (NCRR): collaborator

MeSH Terms

Conditions

Low Back Pain; Chronic Disease; Back Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Natalia Morone, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: July 2, 2007
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 6, 2018

Record last verified: 2016-01