Back Pain Lower Back ChronicNCT03299192
Tai Chi for Chronic Low Back Pain in Older Adults
A study testing Tai Chi, Health Education and Usual Medical Care in people with Back Pain Lower Back Chronic, run by Kaiser Permanente at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Tai Chi, Health Education and Usual Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
Show all 9Show fewer
- Conditions making consent or treatment difficult
- Conditions making treatment unsafe or inappropriate
- Unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
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.
Read the 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.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Tai Chi, Health Education, Usual Medical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Yang Style Tai Chi
Health EducationBehavioural
Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical CareOther
Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Tai Chi; Other: Usual Medical Care |
| Health Education | Active comparator | twice weekly classes for 12 weeks Receives: Behavioral: Health Education; Other: Usual Medical Care |
| Usual Medical Care | Active comparator | the usual care to which participants are entitled by their health insurance Receives: Other: Usual Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start1 May 2016
- Primary completion31 Mar 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of Tai Chi to Health Education and to Usual Medical Care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299192
- Sponsor's protocol ID
- R34AT009052
- Status last verified
- Mar 2024
- First submitted
- 31 May 2017
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Chronic Low Back Pain in Older Adults
- ClinicalTrials.gov ID
- NCT03299192
- Acronym / sponsor ID
- R34AT009052
- Conditions
- Back Pain Lower Back Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Comparison of Tai Chi to Health Education and to Usual Medical Care
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai Chi, Other: Usual Medical Caretwice 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 | Behavioral: Health Education, Other: Usual Medical Caretwice weekly classes for 12 weeks |
| Usual Medical Care | Active comparator | Other: Usual Medical Carethe usual care to which participants are entitled by their health insurance |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- • Be men or women at least 65 years of age
Key exclusion criteria (9 listed)
- • Have certain specific conditions of LBP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiYang Style Tai Chi | Behavioural | Tai Chi |
| Health EducationComprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain | Behavioural | Health Education |
| Usual Medical CareMedications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate. | Other | Health Education, Tai Chi, Usual Medical Care |
Primary outcome
Change in Roland Morris Disability Questionnaire Score
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi, Health Education and Usual Medical Care in people with Back Pain Lower Back Chronic, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Roland Morris Disability Questionnaire Score (time frame: Baseline, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.