Tai Chi for Chronic Low Back Pain in Older Adults
Primary Purpose
Back Pain Lower Back Chronic
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Health Education
Usual Medical Care
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain Lower Back Chronic
Eligibility Criteria
Inclusion Criteria:
• Be men or women at least 65 years of age
- Have low back pain that has persisted for at least three months
- Have had back pain on at least half the days in the last 6 months
- Have at least moderate intensity low back pain
- Have some activity limitations due to back pain
- Be members of Kaiser Permanente Washington integrative health care system or have a regular source of health care and health insurance
- Have normal cognition or only mild cognitive impairment
- Be capable of understanding the study procedures and complying with them for the entire study period.
- Live close enough to the class site for attendance to be practical
- Give informed consent
Exclusion Criteria:
• Have certain specific conditions of LBP
- Prior lumbar spine surgery
- Have sciatica, or scheduled visits to a neurosurgeon or orthopedic surgeon.
- Receiving or seeking compensation for back pain
- Red flags of serious underlying illness
- Have practiced Tai Chi or yoga recently. Have other disabling conditions that might confound treatment effects
- Conditions making consent or treatment difficult
- Conditions making treatment unsafe or inappropriate
- Unwillingness to give informed consent
Sites / Locations
- Kaiser Permanente Washington Health Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Tai Chi
Health Education
Usual Medical Care
Arm Description
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
twice weekly classes for 12 weeks
the usual care to which participants are entitled by their health insurance
Outcomes
Primary Outcome Measures
Change in Roland Morris Disability Questionnaire Score
standard measure of back-related disability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03299192
Brief Title
Tai Chi for Chronic Low Back Pain in Older Adults
Official Title
Tai Chi for Chronic Low Back Pain in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is a major gap in knowledge about safe and effective treatment options for older adults with chronic low back pain. This project will determine the feasibility of conducting a full-scale trial evaluating Tai Chi, a promising "mind-body" intervention that seems particularly well-suited for older adults with chronic low back pain.
Detailed Description
The ultimate goal of this project is to help fill the substantial gap in knowledge about safe and effective treatments for older adults with chronic low back pain. This deficiency is a particular problem because treatments that have been found safe and effective for younger adults may not be appropriate for an older population that is at higher risk of adverse effects and that may have different needs and treatment preferences. Tai Chi, which has been found effective for chronic back pain in younger adults, seems particularly well-suited for older adults with chronic low back pain because it includes multiple therapeutic elements, is gentle and has been found beneficial for a variety of health conditions more common to older adults. The goal of this project is to prepare the foundation for successfully conducting a full-scale trial evaluating the effectiveness of two doses of Tai Chi (Standard and Enhanced, which includes Standard + Maintenance Tai Chi) for improving chronic low back pain in older adults over the course of a year.
In the first phase of this study (Aim 1), the the Investigators will focus on finalization of a Standard Tai Chi protocol, development of the maintenance Tai Chi protocol and development of a credible attention control group. In the course of finalizing the feasibility trial documents, members of the research study team will work with patient partners (older adults with chronic low back pain) to adapt strategies for recruitment, adherence to Tai Chi, safety, and optimizing follow-up rates for this population and the Investigators will finalize the inclusion/exclusion criteria to maximize safety and generalizability.
After finalizing the key study components, the Investigators will conduct a randomized feasibility trial comparing Enhanced Tai Chi with Health Education and Usual Medical Care. Sixty-four older adults with cLBP - 65+ years of age will be randomized to the Enhanced (standard + maintenance) Tai Chi, to Health Education or to Usual Medical Care. Outcomes will be collected at 12, 26, and 52 weeks. The Investigators will evaluate the adequacy of key elements of the study developed in Aim 1 for inclusion in a full-scale trial. Finally, the research study team will conduct debriefing discussion groups with 30 trial participants to elicit their ideas for improving the procedures and protocols. This evaluation will address the overall feasibility of conducting a large trial and the value of including the Enhanced dose Tai Chi treatment arm.
If successful, this feasibility study will pave the way for conducting an adequately-powered randomized\ controlled trial evaluating the ability of Tai Chi to reduce the impact of chronic low back pain on older adults. In view of the absence of knowledge about clearly safe and effective treatments for this population, this line of research has the potential for substantially reducing the suffering of many Americans with back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of Tai Chi to Health Education and to Usual Medical Care
Masking
Outcomes Assessor
Masking Description
Research Specialists will be unaware of study group.
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
twice weekly classes for 12 weeks
Arm Title
Usual Medical Care
Arm Type
Active Comparator
Arm Description
the usual care to which participants are entitled by their health insurance
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
Yang Style Tai Chi
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Intervention Type
Other
Intervention Name(s)
Usual Medical Care
Intervention Description
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Primary Outcome Measure Information:
Title
Change in Roland Morris Disability Questionnaire Score
Description
standard measure of back-related disability
Time Frame
Baseline, 12, 26, 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Be men or women at least 65 years of age
Have low back pain that has persisted for at least three months
Have had back pain on at least half the days in the last 6 months
Have at least moderate intensity low back pain
Have some activity limitations due to back pain
Be members of Kaiser Permanente Washington integrative health care system or have a regular source of health care and health insurance
Have normal cognition or only mild cognitive impairment
Be capable of understanding the study procedures and complying with them for the entire study period.
Live close enough to the class site for attendance to be practical
Give informed consent
Exclusion Criteria:
• Have certain specific conditions of LBP
Prior lumbar spine surgery
Have sciatica, or scheduled visits to a neurosurgeon or orthopedic surgeon.
Receiving or seeking compensation for back pain
Red flags of serious underlying illness
Have practiced Tai Chi or yoga recently. Have other disabling conditions that might confound treatment effects
Conditions making consent or treatment difficult
Conditions making treatment unsafe or inappropriate
Unwillingness to give informed consent
Facility Information:
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Tai Chi for Chronic Low Back Pain in Older Adults
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