Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03299192 |
| Other study ID # |
R34AT009052 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2016 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
March 2024 |
| Source |
Kaiser Permanente |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
