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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
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

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

Inclusion Criteria:

All participants will be included if they are:

  1. 65 years of age or older,
  2. have intact cognition (Mini-Mental Status Exam (MMSE) >23),
  3. CLBP, defined as moderate pain occurring daily or almost every day for at least the previous three months, and
  4. speak English.

Exclusion Criteria:

They will be excluded if they:

  1. do not meet the above inclusion criteria,
  2. have previously participated in a mindfulness meditation program, and
  3. 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

    First Posted
    January 3, 2008
    Last Updated
    January 14, 2008
    Sponsor
    University of Pittsburgh
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    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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