Back Pain Lower Back Chronic
Conditions
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.
Interventions
BEHAVIORALTai Chi
Yang Style Tai Chi
BEHAVIORALHealth Education
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
OTHERUsual Medical Care
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research Specialists will be unaware of study group.
Intervention model description
Comparison of Tai Chi to Health Education and to Usual Medical Care
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Roland Morris Disability Questionnaire Score | Baseline, 3, 6, 12 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 12 |
| 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. | 17 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Fell before classes started | 1 | 0 | 0 |
| Overall Study | Other | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Tai Chi | Health Education | Usual Medical Care | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 12 Participants | 17 Participants | 57 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 73.2 Years STANDARD_DEVIATION 5.9 | 73.6 Years STANDARD_DEVIATION 5.5 | 71.8 Years STANDARD_DEVIATION 3.8 | 72.9 Years STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 9 Participants | 11 Participants | 41 Participants |
| Region of Enrollment United States | 28 participants | 12 participants | 17 participants | 57 participants |
| Roland-Morris Disability Measure Questionnaire | 11.4 units on a scale STANDARD_DEVIATION 4.3 | 11.7 units on a scale STANDARD_DEVIATION 3.7 | 9.4 units on a scale STANDARD_DEVIATION 4.2 | 10.8 units on a scale STANDARD_DEVIATION 4.2 |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 11 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 4 Participants | 6 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 12 | 0 / 17 |
| other Total, other adverse events | 0 / 28 | 0 / 12 | 0 / 17 |
| serious Total, serious adverse events | 0 / 28 | 0 / 12 | 0 / 17 |
Outcome results
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
Time frame: Baseline, 3, 6, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Roland Morris Disability Questionnaire Score | 6 Months | -3.64 units on a scale |
| Tai Chi | Change in Roland Morris Disability Questionnaire Score | 3 Months | -4.38 units on a scale |
| Tai Chi | Change in Roland Morris Disability Questionnaire Score | 12 Months | -5.20 units on a scale |
| Health Education | Change in Roland Morris Disability Questionnaire Score | 6 Months | -1.92 units on a scale |
| Health Education | Change in Roland Morris Disability Questionnaire Score | 3 Months | -0.12 units on a scale |
| Health Education | Change in Roland Morris Disability Questionnaire Score | 12 Months | -0.82 units on a scale |
| Usual Medical Care | Change in Roland Morris Disability Questionnaire Score | 3 Months | 0.18 units on a scale |
| Usual Medical Care | Change in Roland Morris Disability Questionnaire Score | 12 Months | -2.89 units on a scale |
| Usual Medical Care | Change in Roland Morris Disability Questionnaire Score | 6 Months | -2.39 units on a scale |
p-value: 0.001GEE with Ancova features