Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801588
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2023-03-24
Brief Title:
Participating in Tai Chi to Reduce Back Pain and Improve Quality of Life
Sponsor:
New York Medical College
Organization:
New York Medical College
Study Overview
Official Title:
Tai Chi Mild Exercise The Potential for Reducing Pain and Improving Quality of Life Among Those With Back Pain
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tai 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 tai 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 tai 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 tai 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 tai 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 Tai Chi and Qigong exercise
Consent for participation in the tai 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 tai chi classes cannot advance to the survey or participate in the tai 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 tai chi and qigong exercise treatment group and a waitlist control group The treatment group started the tai 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 tai 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 tai 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 tai 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 Fishers 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 interventionstudy 25 qualitative interviews will be conducted to assess the barriers and facilitators related to implementing the online Tai Chi and Qigong intervention
Study Design and Methods
The study will be a prospective randomized controlled trial with two groups a tai 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 Tai Chi and Qigong exercise
Consent for participation in the tai 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 tai chi classes cannot advance to the survey or participate in the tai 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 tai chi and qigong exercise treatment group and a waitlist control group The treatment group started the tai 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 tai 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 tai 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 tai 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 Fishers 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 interventionstudy 25 qualitative interviews will be conducted to assess the barriers and facilitators related to implementing the online Tai Chi and Qigong intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None