Aging Successfully With Pain

Low Back Pain Clinical Trial

Official title:

Effectiveness of a Mind-Body Program for Older Adults With Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405716
• Other study ID #: PRO09100150
• Secondary ID: R01AG034078-01
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: September 30, 2017
• Start date: February 2011
• Est. completion date: September 2015

Study information

• Verified date: September 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Mindfulness Meditation
8-week mindfulness based program will be compared to and education control group
• Health Education
8-week health education program

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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