NCT05764382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

January 27, 2023

Last Update Submit

March 1, 2023

Conditions

Low Back Pain

Keywords

Tai ChiQigong

Outcome Measures

Primary Outcomes (1)

  • Change in the Oswestry Disability Index 3 months after intervention

    0 to 100 scale

    baseline, 3 months

Secondary Outcomes (4)

  • Change in visual analogue scale (VAS) for low back pain

    baseline, 3 months

  • Change in VAS leg pain

    baseline, 3 months

  • The "SF-36," Short Form Health Survey questionnaire

    baseline, 3 months

  • 9-Item Pittsburgh Sleep Quality Index

    baseline, 3 months

Study Arms (2)

T'ai Chi and Qigong Rehabilitation

EXPERIMENTAL
Behavioral: T'ai Chi and Qigong Rehabilitation

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

T'ai Chi and Qigong RehabilitationBEHAVIORAL

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.

T'ai Chi and Qigong Rehabilitation
Usual careOTHER

Usual care as per primary care physican, physical therapist.

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbytarian Hospital

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Yang Yang, PhD

    Director Center for Taiji and Qigong Studies & Wa-Qi.com https://www.wa-qi.com

    STUDY DIRECTOR

Central Study Contacts

Pravesh S Gadjradj, MD, MSc

CONTACT

+1‭(201) 263-1212‬p.gadjradj@erasmusmc.nl

Kenneth Kapp

CONTACT

kenneth_knapp@nymc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, Epidemiologist

Study Record Dates

First Submitted

January 27, 2023

First Posted

March 10, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

US(1)