Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Mindfulness based stress reduction program
Wait-list control
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
All participants will be included if they are:
- 65 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, and
- speak English.
Exclusion Criteria:
They will be excluded if they:
- do not meet the above inclusion criteria,
- have previously participated in a mindfulness meditation program, and
- have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Wait-list control
Arm Description
8-week mindfulness based stress reduction program
Wait-list received no intervention during the time the treatment group received the 8-week program
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00594243
First Posted
January 3, 2008
Last Updated
January 14, 2008
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00594243
Brief Title
Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot feasibility experimental study is designed as a randomized wait-list controlled trial of mindfulness meditation for CLBP. A sample of 37 older adults 65 years of age and older will be recruited from a chronic pain clinic, posted flyers, and newspaper advertisements over a 6-month period. Eligibility will be determined by self-report from a checklist reviewed with potential participants over the phone (see appendix for checklist). Pre-intervention study participants will be consented and study measures obtained. After consent and baseline measures, participants will be randomized in blocks of six using a simple randomization process with no stratification using a table of random numbers. After randomization, participants in the intervention group will receive the intervention of eight weekly 90-minute mindfulness meditation sessions. Instead of waiting until all 37 participants have been recruited into the study to do the intervention, the intervention will be done on a rolling basis. This means there will be a minimum of 6 participants per intervention group, with the possibility of three separate intervention groups. If recruitment goes better than expected, then we will offer the intervention to all 18 participants at one time. Controls will not receive any intervention during this time. Immediately post-intervention the measures will be administered again to participants and wait-list controls. Once the intervention is complete and participants and wait-list controls have completed post-intervention measures the mindfulness meditation program will be offered to the wait-list controls. We will try to combine the wait-list controls into one eight-week program. 3 months after the intervention is completed, participants will be asked to complete the measures a third time and any mindfulness meditation they continue to do at home will be quantified.
The primary hypotheses are:
We expect to be able to recruit 37 eligible individuals with CLBP into the study within a six-month period.
We expect participants randomized to the mindfulness meditation intervention to meet an adherence standard of attending 75% of the 8 weekly 90-minute sessions.
We expect mindfulness meditation will result in a moderate effect size difference (0.5) between the intervention participants and wait-list control participants on outcome measures of pain, mood, physical function, attention, and QOL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
8-week mindfulness based stress reduction program
Arm Title
Wait-list control
Arm Type
Active Comparator
Arm Description
Wait-list received no intervention during the time the treatment group received the 8-week program
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction program
Intervention Description
8-week mindfulness based stress reduction program
Intervention Type
Other
Intervention Name(s)
Wait-list control
Intervention Description
No treatment given.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All participants will be included if they are:
65 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, and
speak English.
Exclusion Criteria:
They will be excluded if they:
do not meet the above inclusion criteria,
have previously participated in a mindfulness meditation program, and
have serious underlying illness (like malignancy, infection, unexplained fever, weight loss or recent trauma) causing their pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia E Morone, MD, MSc
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain
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