Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life

NCT05801588 | Completed

• 1 other identifier: GMB15574
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Low Back Pain

Keywords

T'ai Chi; Qigong

Outcome Measures

Primary Outcomes (1)

• Change in ODI 3 months after intervention

  The Oswestry Disability Index (ODI) is a commonly used outcome measure for individuals with low back pain. The ODI includes 10 questions about pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling, each based upon a 6-item Likert scale. Each section is scored on a 0-5 scale, 5 representing the greatest disability. If a respondent does not answer all 10 questions, then average scores and levels of disability are adjusted to account for skipping. If all 10 questions are answered, then the maximum score possible is 50 (10 x 5); if 9 are answered, then the maximum score is 45 (9 x 5), and so on. Someone with a total score of 18 out of a maximum of 50 (all 10 questions answered) would have a percentage score of 18/50 = 35%. A score of 18 out of 45 (9 questions answered) would result in a percentage score of 18/45 = 40%. Categories of disability range from minimal, moderate, severe, crippled, and bed-bound.

  baseline, 3 months

Secondary Outcomes (4)

• Change in VAS back pain

  baseline, 3 months

• Change in VAS leg pain

  baseline, 3 months

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

  baseline, 3 months

• 19-Item Pittsburgh Sleep Quality Index

  baseline, 3 months

Study Arms (2)

T'ai Chi and Qigong Rehabilitation

EXPERIMENTAL

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. The practice is gentle yet powerful, aiming to relieve and prevent back, neck, and hip pain. It has an online teaching module and is uniquely suited for our study population. The program requires no difficult movement transitions, but still contains all essential parts including meditation. The WaQi program has less psychological stress and physical challenge than other exercise activities because it can be performed either sitting, standing, and lying down.

Other: T'ai Chi and Qigong Rehabilitation

Usual care

ACTIVE COMPARATOR

The control arm will receive the same 12-week, twice-per-week t'ai chi and qigong gentle movement and meditation, online live T'ai Chi and Qigong teaching module from Jan. 26, 2023 to April 17, 2023.

Other: Usual care

Interventions

T'ai Chi and Qigong Rehabilitation OTHER

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. The practice is gentle yet powerful, aiming to relieve and prevent back, neck, and hip pain. It has an online teaching module and is uniquely suited for our study population. The program requires no difficult movement transitions, but still contains all essential parts including meditation. The WaQi program has less psychological stress and physical challenge than other exercise activities because it can be performed either sitting, standing, and lying down.

T'ai Chi and Qigong Rehabilitation

Usual care OTHER

The control arm will receive the same 12-week, twice-per-week t'ai chi and qigong gentle movement and meditation, online live T'ai Chi and Qigong teaching module from Jan. 26, 2023 to April 17, 2023.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females 18 years and over
• 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:

• Excluded if pregnant
• Excluded if subject previously has taken t'ai chi classes
• Excluded if subject has had spine surgery within the last 6 months

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

Related Publications (1)

• Yang Y, McCluskey S, Bydon M, Singh JR, Sheeler RD, Nathani KR, Krieger AC, Mehta ND, Weaver J, Jia L, DeCelle S, Schlagal RC, Ayar J, Abduljawad S, Stovitz SD, Ganesh R, Verkuilen J, Knapp KA, Yang L, Hartl R. A Tai chi and qigong mind-body program for low back pain: A virtually delivered randomized control trial. N Am Spine Soc J. 2024 Sep 8;20:100557. doi: 10.1016/j.xnsj.2024.100557. eCollection 2024 Dec.

  PMID: 39469294 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Kenneth A Knapp, PhD

  New York Medical College, Valhalla, NY 10595

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: September 22, 2022
• Primary Completion: January 30, 2023
• Study Completion: December 26, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following the review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact kenneth\ knapp@nymc.edu

Locations

US (1)