Remote Tai Ji for Low Back Pain

• Sponsor: New York Presbyterian Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05764382
• Collaborator: Center for Taiji and Qigong Studies & Wa-Qi.com (Other)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 60.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Behavioral: T'ai Chi and Qigong Rehabilitation; Other: Usual care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Tai Ji for Low Back Pain: a Randomized Trial
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.
Active Comparator: Usual care	Other: Usual care; Usual care as per primary care physican, physical therapist.

Outcome Measures

Primary Outcome Measures

1. Change in the Oswestry Disability Index 3 months after intervention [baseline, 3 months]

   0 to 100 scale

Secondary Outcome Measures

1. Change in visual analogue scale (VAS) for low back pain [baseline, 3 months]

   0-100 scale

2. Change in VAS leg pain [baseline, 3 months]

   0 to 100 scale

3. The "SF-36," Short Form Health Survey questionnaire [baseline, 3 months]

4. 9-Item Pittsburgh Sleep Quality Index [baseline, 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbytarian Hospital	New York	New York	United States	10021

Sponsors and Collaborators

• New York Presbyterian Hospital
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pravesh Gadjradj, Physician, Epidemiologist, New York Presbyterian Hospital
• ClinicalTrials.gov Identifier: NCT05764382
• Other Study ID Numbers: 27012023
• First Posted: Mar 10, 2023
• Last Update Posted: Mar 10, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pravesh Gadjradj, Physician, Epidemiologist, New York Presbyterian Hospital: Tai Chi; Qigong
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Mar 10, 2023