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

NCT07772154 | Not Yet Recruiting DMC

• 1 other identifier: 30515
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Low-back Pain (cLBP); Low Back Pain

Keywords

tai chi; qigong; meditation; mind-body; virtual care; telehealth; disability; quality of life; cost-effectiveness; non-pharmacologic

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (4)

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

  6 months

• Healthcare costs (RUQ: Resource Use Questionnaire)

  6 months

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

  6 months

• Cost-effectiveness (ICER: incremental cost-effectiveness ratio)

  6 months

Other Outcomes (4)

• Surgery, procedures, imaging

  1 year

• Medication use

  1 year

• Pain responder / recovery

  6 months

Study Arms (2)

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.

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.

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

Interventions

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).

Tai Chi Later; Tai Chi Now

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Medical College: lead
• Weill Medical College of Cornell University: collaborator
• Columbia University: collaborator
• Yale University: collaborator
• Center for Taiji and Qigong Studies (CTQS).: collaborator

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Qigong; Meditation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Kenneth Knapp, PhD

CONTACT

(914) 594-2043; kenneth_knapp@nymc.edu

Allison Asher, DrPH

CONTACT

aasher2@nymc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and program staff not masked; statistician analyzes blinded to group identity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 19, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 16, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)