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Aging Successfully With Pain

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Meditation

Health Education

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Mindfulness, Back Pain, Older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Behavioral-Mindfulness

Behavioral-Health

Arm Description

Mindfulness Meditation

Health Education Class

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01405716

First Posted

July 25, 2011

Last Updated

September 30, 2017

Sponsor

University of Pittsburgh

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT01405716

Brief Title

Aging Successfully With Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Mindfulness, Back Pain, Older adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

282 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Behavioral-Mindfulness

Arm Type

Active Comparator

Arm Description

Mindfulness Meditation

Arm Title

Behavioral-Health

Arm Type

Placebo Comparator

Arm Description

Health Education Class

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Meditation

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Health Education

Intervention Description

8-week health education program

Primary Outcome Measure Information:

Title

Change in the Roland-Morris Questionnaire

Description

Time Frame

Change from Baseline to 8-weeks to 6-months to 12-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Natalia Morone, MD, MS

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26903081

Citation

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.

Results Reference

derived

PubMed Identifier

22115971

Citation

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.

Results Reference

derived

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Aging Successfully With Pain

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