Clinical trial NCT05801588: Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life
Official title: T'ai Chi Mild Exercise: The Potential for Reducing Pain and Improving Quality of Life Among Those With Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: T'ai Chi
Qigong
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in ODI 3 months after intervention
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change in VAS back pain
timeFrame: baseline, 3 months
measure: Change in VAS leg pain
timeFrame: baseline, 3 months
measure: The "SF-36," Short Form Health Survey questionnaire
timeFrame: baseline, 3 months
measure: 19-Item Pittsburgh Sleep Quality Index
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College, Valhalla, NY 10595
name: Kenneth A Knapp, PhD
role: PRINCIPAL_INVESTIGATOR
References: