T'ai Chi Mild Exercise: The Potential for Reducing Pain and Improving Quality of Life Among Those With Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- New York Medical College
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Change in ODI 3 months after intervention
Study Overview
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.
Detailed Description
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.
Study Design and Methods:
The study will be a prospective, randomized controlled trial with two groups: a t'ai chi and qigong exercise (treatment) group and a waitlist control group. The waitlist control group will simply be a comparison group.
The study team will conduct a single-centered, single-blind, parallel design, randomized controlled trial with 300 participants randomly allocated to one of two arms: a waitlist control or a 12-week, twice per week, T'ai Chi and Qigong exercise.
Consent for participation in the t'ai chi gentle movement and meditation program and completion of the baseline and three additional surveys will be included in the Survey. The Informed Consent for participation in the study will be prompted before the start of the initial Survey in Qualtrics. Potential participants of the t'ai chi classes cannot advance to the survey or participate in the t'ai chi program without accepting consent for participation. In the event consent is declined, the survey is prompted to end.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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. 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.
Intervention: T'ai Chi and Qigong Rehabilitation (Other)
Usual care
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.
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Change in ODI 3 months after intervention
Time Frame: baseline, 3 months
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.
Secondary Outcomes
- 19-Item Pittsburgh Sleep Quality Index(baseline, 3 months)
- 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)