An interventional study of Tai Chi and Health Education in Back Pain Lower Back Chronic, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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.
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.
Be men or women at least 65 years of age
Exclusion Criteria:
Have certain specific conditions of LBP
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Behavioral: Tai Chi · Other: Usual Medical Care
twice weekly classes for 12 weeks
Behavioral: Health Education · Other: Usual Medical Care
the usual care to which participants are entitled by their health insurance
Other: Usual Medical Care
Yang Style Tai Chi
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Change in Roland Morris Disability Questionnaire Score
The score of the Roland-Morris Disability Questionnaire (RDMQ) is the total number of items checked, from a minimum of 0 to a maximum of 24, with a higher score indicating a higher experience of disability from back pain. The timeframe of the RMDQ is how a person feels within the last 7 days. Change was calculated as the value of the time point (3, 6, or 12 months) minus baseline
Time frame: Baseline, 3, 6, 12 months
| Milestone | Tai Chi | Health Education | Usual Medical Care |
|---|---|---|---|
| Started | 28 | 12 | 17 |
| Completed | 27 | 10 | 16 |
| Not completed | 1 | 2 | 1 |
| Withdrew: Fell before classes started | 1 | 0 | 0 |
| Withdrew: Other | 0 | 2 | 1 |
The score of the Roland-Morris Disability Questionnaire (RDMQ) is the total number of items checked, from a minimum of 0 to a maximum of 24, with a higher score indicating a higher experience of disability from back pain. The timeframe of the RMDQ is how a person feels within the last 7 days. Change was calculated as the value of the time point (3, 6, or 12 months) minus baseline
| units on a scale | Tai Chi | Health Education | Usual Medical Care |
|---|---|---|---|
| 3 Months | -4.38 (-5.81 to -2.96) | -0.12 (-2.58 to 2.93) | 0.18 (-2.58 to 2.93) |
| 6 Months | -3.64 (-5.64 to -1.65) | -1.92 (-3.73 to -0.11) | -2.39 (-4.79 to 0.01) |
| 12 Months | -5.20 (-7.11 to -3.29) | -0.82 (-3.04 to 1.40) | -2.89 (-4.74 to -1.04) |
Collected over Adverse event information was collected over a 1-year period post-enrollment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tai Chi | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| Health Education | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Usual Medical Care | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 28 | 12 | 17 | 57 |
| Age, Continuous(Years) | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| Mean | 73.2 ± 5.9 | 73.6 ± 5.5 | 71.8 ± 3.8 | 72.9 ± 5.2 |
| Sex: Female, Male(Participants) | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| Female | 16 | 8 | 11 | 35 |
| Male | 12 | 4 | 6 | 22 |
| Race (NIH/OMB)(Participants) | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 0 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 1 | 8 |
| White | 21 | 9 | 11 | 41 |
| More than one race | 0 | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| United States | 28 | 12 | 17 | 57 |
| Roland-Morris Disability Measure Questionnaire(units on a scale) | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| Mean | 11.4 ± 4.3 | 11.7 ± 3.7 | 9.4 ± 4.2 | 10.8 ± 4.2 |
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