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Remote Tai Ji for Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T'ai Chi and Qigong Rehabilitation
Usual care
Sponsored by
New York Presbyterian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Tai Chi, Qigong

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbytarian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

T'ai Chi and Qigong Rehabilitation

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Change in the Oswestry Disability Index 3 months after intervention
0 to 100 scale

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2023
Last Updated
March 1, 2023
Sponsor
New York Presbyterian Hospital
Collaborators
Center for Taiji and Qigong Studies & Wa-Qi.com
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1. Study Identification

Unique Protocol Identification Number
NCT05764382
Brief Title
Remote Tai Ji for Low Back Pain
Official Title
Remote Tai Ji for Low Back Pain: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Hospital
Collaborators
Center for Taiji and Qigong Studies & Wa-Qi.com

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Tai Chi, Qigong

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
T'ai Chi and Qigong Rehabilitation
Arm Type
Experimental
Arm Title
Usual care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
T'ai Chi and Qigong Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care as per primary care physican, physical therapist.
Primary Outcome Measure Information:
Title
Change in the Oswestry Disability Index 3 months after intervention
Description
0 to 100 scale
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in visual analogue scale (VAS) for low back pain
Description
0-100 scale
Time Frame
baseline, 3 months
Title
Change in VAS leg pain
Description
0 to 100 scale
Time Frame
baseline, 3 months
Title
The "SF-36," Short Form Health Survey questionnaire
Time Frame
baseline, 3 months
Title
9-Item Pittsburgh Sleep Quality Index
Time Frame
baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pravesh S Gadjradj, MD, MSc
Phone
+1‭(201) 263-1212‬
Email
p.gadjradj@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Kapp
Email
kenneth_knapp@nymc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Yang, PhD
Organizational Affiliation
Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com
Official's Role
Study Director
Facility Information:
Facility Name
New York Presbytarian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pravesh S Gadjradj, MD
Phone
212-821-0850
Email
psg4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Brendan Mendary, BS
Phone
(212) 821-0850
Email
brm4011@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Roger Hartl, Prof.dr.
First Name & Middle Initial & Last Name & Degree
Sertac Kernaz, MD
First Name & Middle Initial & Last Name & Degree
Rachel Yerden, BSc

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Remote Tai Ji for Low Back Pain

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