Remote Tai Ji for Low Back Pain

Low Back Pain Clinical Trial

Official title:

Remote Tai Ji for Low Back Pain: a Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764382
• Other study ID #: 27012023
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2023
• Source: New York Presbyterian Hospital
• Contact: Pravesh S Gadjradj, MD, MSc
• Phone: +1?(201) 263-1212?
• Email: p.gadjradj[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Other:
• Usual care
Usual care as per primary care physican, physical therapist.

Locations

Country	Name	City	State
United States	New York Presbytarian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Presbyterian Hospital	Center for Taiji and Qigong Studies & Wa-Qi.com

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Oswestry Disability Index 3 months after intervention	0 to 100 scale	baseline, 3 months
Secondary	Change in visual analogue scale (VAS) for low back pain	0-100 scale	baseline, 3 months
Secondary	Change in VAS leg pain	0 to 100 scale	baseline, 3 months
Secondary	The "SF-36," Short Form Health Survey questionnaire		baseline, 3 months
Secondary	9-Item Pittsburgh Sleep Quality Index		baseline, 3 months