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Feasibility of Mindfulness Meditation for Adults 65+ With Chronic Low Back Pain

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ClinicalTrials.gov Identifier: NCT00594243
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : January 15, 2008
Sponsor:
Information provided by:

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:

  1. We expect to be able to recruit 37 eligible individuals with CLBP into the study within a six-month period.
  2. We expect participants randomized to the mindfulness meditation intervention to meet an adherence standard of attending 75% of the 8 weekly 90-minute sessions.
  3. 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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Mindfulness based stress reduction program Other: Wait-list control Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2004
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention
8-week mindfulness based stress reduction program
Behavioral: Mindfulness based stress reduction program
8-week mindfulness based stress reduction program
Active Comparator: Wait-list control
Wait-list received no intervention during the time the treatment group received the 8-week program
Other: Wait-list control
No treatment given.


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594243


Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Natalia E Morone, MD, MSc University of Pittsburgh
More Information

Responsible Party: Natalia Morone/Principal Investigator, University of Pittsburfh
ClinicalTrials.gov Identifier: NCT00594243     History of Changes
Other Study ID Numbers: 0404190
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: January 15, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms