Clinical trial NCT03299192: Tai Chi for Chronic Low Back Pain in Older Adults
Official title: Tai Chi for Chronic Low Back Pain in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 57
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of Tai Chi to Health Education and to Usual Medical Care
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Roland Morris Disability Questionnaire Score
timeFrame: Baseline, 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
References: