Remote Tai Ji for Low Back Pain

Remote Tai Ji for Low Back Pain: a Randomized Trial

The purpose of the study is to examine the implementation strategy, in terms of feasibility and the possible benefits, of a free online Zoom t'ai chi and qigong gentle movement and meditation program to reduce back pain and to improve sleep and quality of life among those with chronic back pain. The primary objective of this study is to examine whether a safe and moderate online t'ai chi and qigong exercise program, offered without cost to individuals with chronic back pain, improves pain levels, sleep, and quality of life; The secondary objective is to explore whether improvements in pain levels are different among smokers and those with unhealthy BMI than among others.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: T'ai Chi and Qigong Rehabilitation; Other: Usual care

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pravesh S Gadjradj, MD, MSc; Phone Number: +1‭(201) 263-1212‬; Email: p.gadjradj@erasmusmc.nl
• Study Contact Backup: Name: Kenneth Kapp; Email: kenneth_knapp@nymc.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • New York Presbytarian Hospital
      • Contact: Pravesh S Gadjradj, MD; Phone Number: 212-821-0850; Email: psg4001@med.cornell.edu
      • Contact: Brendan Mendary, BS; Phone Number: (212) 821-0850; Email: brm4011@med.cornell.edu
      • Principal Investigator: Roger Hartl, Prof.dr.
      • Sub-Investigator: Sertac Kernaz, MD
      • Sub-Investigator: Rachel Yerden, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years and older
• Have experienced low back pain for the last 6 weeks or longer
• Understands written and spoken English
• Be willing to complete the initial survey and 3 additional ones emailed baseline and January 2023
• Be willing and able to provide consent to participate in the survey

Exclusion Criteria:

• pregnany
• previously has taken t'ai chi classes
• spine surgery within the last 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Other: Usual care; Usual care as per primary care physican, physical therapist.
Experimental: T'ai Chi and Qigong Rehabilitation	Behavioral: T'ai Chi and Qigong Rehabilitation; T'ai chi/Qigong is a multidimensional (mind, body, and spirit integrative) and multimodal (strength, flexibility, balance, posture, and light to moderate aerobic) form of exercise that is safe for persons of all ages and physical abilities. The 12-week, twice-per-week t'ai chi and qigong gentle movement and meditation program proposed to be studied is adapted from the WaQi program, a curriculum developed by Master Yang Yang, PhD. Master Yang developed this course based on his own healing journey from severe back pain following a bike accident in 2014.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Oswestry Disability Index 3 months after intervention	0 to 100 scale	baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in visual analogue scale (VAS) for low back pain	0-100 scale	baseline, 3 months
Change in VAS leg pain	0 to 100 scale	baseline, 3 months
The "SF-36," Short Form Health Survey questionnaire		baseline, 3 months
9-Item Pittsburgh Sleep Quality Index		baseline, 3 months

Collaborators and Investigators

• Sponsor: New York Presbyterian Hospital
• Collaborators: Center for Taiji and Qigong Studies & Wa-Qi.com
• Investigators: Study Director: Yang Yang, PhD, Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Tai Chi; Qigong
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 27012023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No