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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi | Experimental | twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months |
|
| Health Education | Active Comparator | twice weekly classes for 12 weeks |
|
| Usual Medical Care | Active Comparator | the usual care to which participants are entitled by their health insurance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi | Behavioral | Yang Style Tai Chi |
| |
| Health Education |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3, 6, 12 months |
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Inclusion Criteria:
• Be men or women at least 65 years of age
Exclusion Criteria:
• Have certain specific conditions of LBP
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 3, 6, 12 months |
|
Adverse event information was collected over a 1-year period post-enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rene Hawkes, Project Manager | Kaiser Permanente | 206-287-2073 | rene.j.hawkes@kp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2017 | Mar 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2017 | Mar 4, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2017 | Mar 4, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D026302 | Tai Ji |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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Comparison of Tai Chi to Health Education and to Usual Medical Care
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Research Specialists will be unaware of study group.
| Behavioral |
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain |
|
| Usual Medical Care | Other | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Roland-Morris Disability Measure Questionnaire | 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. | Mean | Standard Deviation | units on a scale |
|
| 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. |
| OG002 | 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. |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D026741 |
| Physical Therapy Modalities |