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NCT Number: NCT07772154

Virtual Tai Chi for Chronic Low Back Pain (Spine 2027)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Medical College

Valhalla, New York, 10595, United States

Location contact

Allison Asher, DrPH

CONTACT

[email protected]

Allison Asher, DrPH

PRINCIPAL_INVESTIGATOR

Kenneth Knapp, PhD

CONTACT

[email protected]

914-594-2043

Kenneth Knapp, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM)

Behavioral

Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM). Mapped to Arm 1 (immediate) and Arm 2 (delayed start).

Primary outcomes

  1. Disability (ODI v2.1a) ODI: Oswestry Disability Index

    Time frame: 3 months

    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.

  2. Pain severity (BPI-4) BPI-4: Brief Pain Inventory Short Form, 4-item pain severity subscale

    Time frame: 3 months

    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.

Secondary outcomes

  1. Quality of life (EQ-5D-5L: EuroQol 5-Dimension 5-Level questionnaire)

    Time frame: 6 months

    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.

  2. Healthcare costs (RUQ: Resource Use Questionnaire)

    Time frame: 6 months

    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

  3. Work productivity (WPAI-SHP: Work Productivity and Activity Impairment Questionnaire, Specific Health Problem version)

    Time frame: 6 months

    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

  4. Cost-effectiveness (ICER: incremental cost-effectiveness ratio)

    Time frame: 6 months

    Incremental cost per QALY gained. Time Frame: T0 to T6.

Other outcomes

  1. Surgery, procedures, imaging

    Time frame: 1 year

    Incident and scheduled spine surgery; epidural injections, ablations, MRI, CT, X-ray. Time Frame: through T6 (T12 for treatment).

  2. Medication use

    Time frame: 1 year

    Self-reported changes in OTC and prescription pain medication. Time Frame: T2, T3, T6 (T12 treatment).

  3. Pain responder / recovery

    Time frame: 6 months

    Proportion with >=30% BPI reduction; recovery (average pain <=1/10). Time Frame: T3, T6.

  4. Qualitative experience

    Time frame: 6 months

    Semi-structured interviews. Time Frame: T3 and T6. Semi-structured qualitative interviews will be conducted with up to 20 participants by telephone or Zoom, lasting approximately 30 to 60 minutes each and audio-recorded with participant consent. Up to 10 participants who discontinue will be invited to interview separately. Interviews explore participant experience of the virtually delivered tai chi program, including perceived benefit, barriers to home practice, and acceptability of virtual delivery. This is a qualitative outcome measure. It is not scored on a scale, and no minimum or maximum values or direction of benefit apply. Interview transcripts will be analyzed thematically, and results will be reported as the themes identified and the number of participants contributing to each theme.

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Asher, DrPH

CONTACT

[email protected]

Kenneth Knapp, PhD

CONTACT

[email protected]

(914) 594-2043

Sponsors and collaborators

Lead sponsor

New York Medical College

Other

Collaborators

  • Center for Taiji and Qigong Studies (CTQS).
  • Columbia University
  • Weill Medical College of Cornell University
  • Yale University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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