Low Back PainNCT07772154
Virtual Tai Chi for Chronic Low Back Pain (Spine 2027)
A study testing Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM) in people with Low Back Pain and Chronic Low-back Pain (cLBP), run by New York Medical College at 1 site in United States.
Trial summary
This study tests whether a virtually delivered integrated tai chi, qigong, and meditation program, added to usual care, improves chronic low back pain, disability, quality of life, and healthcare costs compared with usual care alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Chronic Low-back Pain (cLBP)
- What is being tested?
- Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 15 Feb 2028
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Current non-specific low back pain lasting 12 weeks or more, with average pain over the past 7 days rated 4 or higher on a 0 to 10 scale
- Understands written and spoken English
- Has consistent internet access and is able to participate in virtual sessions
- Agrees to appear on video during tai chi sessions, visible to the instructor and other participants
- Willing to participate in a 12-month study including a 3-month foundation training phase with two 60-minute virtual live tai chi classes per week, 10 minutes of daily home practice, monthly 60-minute booster sessions during months 4 through 12, and five online surveys over 12 months at months 0, 2, 3, 6, and 12
- Willing and able to provide informed consent
Who cannot join
- Currently pregnant
- Regular tai chi or qigong practice or research study participation in the past 5 years
- History of spine surgery within the past 6 months
- Severe psychiatric or medical comorbidities that, in the principal investigator's judgment, would make participation unsafe or not feasible
- Note on the second exclusion bullet: the protocol wording leaves open whether "research study participation" means participation in any research study or only in tai chi or qigong research. That wording has been carried over exactly as approved rather than clarified here, because the registry record should match the protocol. If the ambiguity is worth resolving, it belongs in a future amendment and then in a record update, not in this response.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Allison Asher, DrPH contact
United States1 site
New York Medical College
Valhalla, New York, 10595
Kenneth Knapp, PhD, 914-594-2043, Kenneth_Knapp@nymc.edu
Allison Asher, DrPH, aasher2@nymc.edu
About this study
Official title: A Pragmatic Randomized Controlled Trial of Virtual Tai Chi for Chronic Low Back Pain: Effects on Disability, Pain, Quality of Life, and Healthcare Costs
This study tests whether a virtually delivered integrated tai chi, qigong, and meditation program, added to usual care, improves chronic low back pain, disability, quality of life, and healthcare costs compared with usual care alone. Adults with chronic low back pain are randomized to begin the program immediately (Tai Chi Now) or after a six-month period (Tai Chi Later). Outcomes are collected by online survey over twelve months.
Read the detailed description
Pragmatic randomized crossover design with delayed start. Participants are randomized 1:1 to Tai Chi Now (immediate program plus usual care) or Tai Chi Later (usual care for six months, then delayed access to the same twelve-month program). Delivery is entirely virtual by Zoom. The program is a three-month foundation phase (two 60-minute live classes per week) followed by nine months of monthly booster sessions and guided home practice. Co-primary clinical endpoints are change in pain (BPI-4) and disability (ODI) from baseline to three months, both required to reach significance. Secondary endpoints include EQ-5D-5L quality of life, healthcare costs, work productivity (WPAI), and cost-effectiveness. Participants and program staff are not blinded; the study statistician analyzes data blinded to group identity.
- Conditions
- Low Back Pain, Chronic Low-back Pain (cLBP)
- Being tested
- Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM)
- Keywords
- tai chi, qigong, meditation, mind-body, virtual care, telehealth, disability, quality of life, cost-effectiveness, non-pharmacologic
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM)Behavioural
Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM). Mapped to Arm 1 (immediate) and Arm 2 (delayed start).
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Now | Experimental | Begins the virtually delivered integrated tai chi, qigong, and meditation program (VDTQM) on February 1, 2027, in addition to usual care: a three-month foundation phase (two live Zoom classes per week) then nine months of monthly boosters and daily guided home practice, with a Month 12 survey. Receives: Behavioral: Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM) |
| Tai Chi Later | Active comparator | Usual care during the six-month primary phase, then the same twelve-month program beginning [Aug 23 or Sept 13], 2027, with the foundation phase delivered as a weekly video series on the same schedule as the live classes. Receives: Behavioral: Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability (ODI v2.1a) ODI: Oswestry Disability Index
Change in Oswestry Disability Index total from baseline to 3 months. Time Frame: T0 to T3. Co-primary with BPI-4; both must reach significance. The Oswestry Disability Index version 2.1a (ODI) is a 10-item self-report questionnaire assessing back pain related disability across pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each item is scored 0 to 5 and the total is converted to a percentage. Scores range from 0 to 100 percent, with higher scores indicating greater disability, so a decrease in score is a better outcome. Proportional scoring is applied when items are missing, per standard ODI version 2.1a scoring. This outcome is the change in ODI total score from baseline to 3 months. It is co-primary with the Brief Pain Inventory Short Form 4-item pain severity subscale (BPI-4); both must reach statistical significance to claim treatment effectiveness.
Measured: 3 months
Pain severity (BPI-4) BPI-4: Brief Pain Inventory Short Form, 4-item pain severity subscale
Change in Brief Pain Inventory 4-item average from baseline to 3 months. Time Frame: T0 to T3. The Brief Pain Inventory Short Form (BPI) 4-item pain severity subscale asks participants to rate their pain at its worst, at its least, on average, and right now during the past 7 days, each on a 0 to 10 numeric rating scale. The subscale score is the mean of the four items and ranges from 0 to 10, with higher scores indicating greater pain severity, so a decrease in score is a better outcome. This outcome is the change in BPI-4 score from baseline to 3 months. It is co-primary with the Oswestry Disability Index (ODI); both must reach statistical significance to claim treatment effectiveness.
Measured: 3 months
Secondary outcomes (4)
Quality of life (EQ-5D-5L: EuroQol 5-Dimension 5-Level questionnaire)
EQ-5D-5L index; input to QALYs (QALY: quality-adjusted life year.) Time Frame: T0, T3, T6. The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) measures health-related quality of life across five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each domain has five response levels. Responses are converted into a single index score using the United States value set. Index scores range from -0.573 to 1.000, where 1.000 represents full health and 0 represents a health state judged equivalent to death; negative values represent health states judged worse than death. Higher scores indicate better health-related quality of life, so an increase in score is a better outcome. The index score is also the input to the quality-adjusted life year (QALY) calculation, computed as area under the curve from baseline to 6 months.
Measured: 6 months
Healthcare costs (RUQ: Resource Use Questionnaire)
Total costs from Resource Use Questionnaire (visits, procedures, imaging, medications). Time Frame: T0 to T6 .The Resource Use Questionnaire (RUQ) is a self-report instrument capturing healthcare utilization for back pain over the prior 3 months, including provider visits, procedures, imaging, and medications. It is adapted from previously funded studies and aligned with the Database of Instruments for Resource Use Measurement (DIRUM) framework. The RUQ is not a scored scale; it records counts of services used. Reported utilization is multiplied by standard unit costs to produce total healthcare costs, reported in United States dollars, accumulated from baseline through 6 months. The theoretical minimum is $0 and there is no upper bound. Lower total costs indicate a better outcome from the health system perspective
Measured: 6 months
Work productivity (WPAI-SHP: Work Productivity and Activity Impairment Questionnaire, Specific Health Problem version)
Productivity loss and activity impairment. Time Frame: T0 to T6. The Work Productivity and Activity Impairment Questionnaire, Specific Health Problem version (WPAI-SHP) is a six-item self-report instrument assessing the effect of a specified health problem, in this study chronic low back pain, on work and on regular daily activities during the past 7 days. Standard scoring converts responses into impairment percentages ranging from 0 to 100 percent, with higher percentages indicating greater impairment, so a decrease is a better outcome. The score reported for this outcome measure is total work productivity impairment, which combines work time missed because of back pain (absenteeism) with impairment experienced while working (presenteeism), and is calculated for participants who are employed. Activity impairment, which is calculated for all participants regardless of employment status, is collected on the same instrument and used as a secondary input to the employer-perspective econo
Measured: 6 months
Cost-effectiveness (ICER: incremental cost-effectiveness ratio)
Incremental cost per QALY gained. Time Frame: T0 to T6.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion16 Aug 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Taiji and Qigong Studies (CTQS)., Weill Medical College of Cornell University, Columbia University, Yale University
- Responsible party
- Principal investigator, Allison Asher, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772154
- Sponsor's protocol ID
- 30515
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified aggregate results will be shared; no individual participant data sharing and no banking for unspecified future use, consistent with the protocol.