Remote Tai Ji for Low Back Pain | NCT05764382

Studies
Remote Tai Ji for Low Back Pain

NCT05764382

Sponsor

New York Presbyterian Hospital

Status

Unknown status

Last Update Posted

Mar 10, 2023Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

T'ai Chi and Qigong Rehabilitation
Usual care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Mar 1, 2023

First Posted Date

Mar 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2023

Last Update Posted Date

Mar 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pravesh Gadjradj, Physician, Epidemiologist, New York Presbyterian HospitalPrincipal Investigator

Lead Sponsor

New York Presbyterian HospitalOTHER

Collaborators

Name	Class
Center for Taiji and Qigong Studies & Wa-Qi.com	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
T'ai Chi and Qigong Rehabilitation	Experimental		Behavioral: T'ai Chi and Qigong Rehabilitation
Usual care	Active Comparator		Other: Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
T'ai Chi and Qigong Rehabilitation	Behavioral	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pravesh S Gadjradj, MD, MSc	Contact	+1‭(201) 263-1212‬		p.gadjradj@erasmusmc.nl
Kenneth Kapp	Contact			kenneth_knapp@nymc.edu

Overall Officials

Name	Affiliation	Role
Yang Yang, PhD	Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York Presbytarian Hospital	Recruiting	New York	New York	10021	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026302	Tai Ji

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026241	Exercise Movement Techniques

Browse Leaves

Not provided

Browse Branches

Not provided