Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2016-05-01
2020-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tai Chi
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Tai Chi
Yang Style Tai Chi
Usual Medical Care
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Health Education
twice weekly classes for 12 weeks
Health Education
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical Care
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Usual Medical Care
the usual care to which participants are entitled by their health insurance
Usual Medical Care
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Interventions
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Tai Chi
Yang Style Tai Chi
Health Education
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical Care
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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Locations
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Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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