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

NCT ID: NCT05801588

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-22
• Study Completion Date: 2023-12-26

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.

Statistical 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 treatment group started the t'ai chi and qigong classes in September 2022; the waitlist group was offered instruction beginning in January 2023. The waitlist control group will simply be a comparison group. Thus, we will be comparing the outcomes of key measures between the treatment group receiving t'ai chi and qigong instruction starting in September and the waitlist control group.

After the baseline survey was closed to further responses, the data was exported as an SPSS file, then converted to Stata, by the PI onto his NYMC-issued, password-protected computer, which is in a secure space. Participants then were randomized either to start class in September 2022 (the treatment group) or January 2023 (the waitlisted control group).

The treatment and waitlist control groups were randomized using Stata statistical software through a standard randomization algorithm. The algorithm would ensure that participants had an equal chance of being assigned to either arm. A simple, post-randomization analysis of participants assigned to the two arms was conducted to confirm that participants in the treatment and control groups are similar in terms of baseline Oswestry Disability Index (ODI) scores. (A comparison of means t-test will be used.)

Previously validated, self-administered survey instruments will be included in the Survey to be used to assess the primary outcome of interest, low back pain, as well as associated outcomes of sleep and quality of life, including:

• The Oswestry Disability Index (primary pain measurement)
• The Visual Analog Scale for Back and Leg Pain (additional pain measurement)
• The "SF-36," Short Form Health Survey questionnaire (health and quality of life)
• 19-Item Pittsburgh Sleep Quality Index

A maximum of 300 people with chronic low back pain were selected to participate in the program on a first-come basis. The treatment and control groups were divided into roughly equal numbers, with a maximum of 150 participants selected for participation in the live Zoom t'ai chi classes starting in September 2022 and a maximum of 150 participants selected for the waitlist control. The project will include a minimum of 200 total recruited participants, which, accounting for possible attrition, will result in a minimum of 50 participants in each study group, enough to statistically analyze the primary outcome of pain alleviation (see Sample Size and Power below).

Statistical comparisons of the treatment and waitlist control group will be based on four surveys:

• Baseline survey sent three weeks before the start of September 2022 of the t'ai chi and qigong gentle movement and mediation class. The survey closed one week prior to class start.
• Intermediate survey sent after Week 8 of the September start.
• Post-intervention survey sent the day after the last of the classes that started in September (that is, after the 24th class).
• Follow-up survey sent four weeks later.

Separate statistical tests will be run by secondary variables of interest, including smoking status and BMI; specifically, the main outcomes of interest (pain, sleep, and quality of life) will be cross-tabulated by the secondary variables. Similar statistical comparisons will be made between pain levels and sleep, and between pain levels and quality of life measures. A Fisher's exact test will be applied to test the statistical significance of such cross-tabulated variables.

Descriptive statistics of all pertinent measures of all participants, as well as simple correlation matrices, will also be included in our analysis.

At the completion of the intervention/study, 25 qualitative interviews will be conducted to assess the barriers and facilitators related to implementing the online T'ai Chi and Qigong intervention.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

T'ai Chi and Qigong Rehabilitation

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: 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.

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 Type: 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 Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth A Knapp, PhD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College, Valhalla, NY 10595

Locations

New York Medical College

Valhalla, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39469294 (View on PubMed)

Other Identifiers

GMB15574

Identifier Type: -

Identifier Source: org_study_id