Trial Outcomes & Findings for Tai Chi for Chronic Low Back Pain in Older Adults (NCT NCT03299192)
NCT ID: NCT03299192
Last Updated: 2024-04-02
Results Overview
The score of the Roland-Morris Disability Questionnaire (RDMQ) is the total number of items checked, from a minimum of 0 to a maximum of 24, with a higher score indicating a higher experience of disability from back pain. The timeframe of the RMDQ is how a person feels within the last 7 days. Change was calculated as the value of the time point (3, 6, or 12 months) minus baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline, 3, 6, 12 months
Results posted on
2024-04-02
Participant Flow
Participant milestones
| Measure |
Tai Chi
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Tai Chi: Yang Style Tai Chi
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Health Education
twice weekly classes for 12 weeks
Health Education: Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Usual Medical Care
the usual care to which participants are entitled by their health insurance
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
12
|
17
|
|
Overall Study
COMPLETED
|
27
|
10
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Tai Chi
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Tai Chi: Yang Style Tai Chi
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Health Education
twice weekly classes for 12 weeks
Health Education: Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Usual Medical Care
the usual care to which participants are entitled by their health insurance
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
|---|---|---|---|
|
Overall Study
Fell before classes started
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
2
|
1
|
Baseline Characteristics
Tai Chi for Chronic Low Back Pain in Older Adults
Baseline characteristics by cohort
| Measure |
Tai Chi
n=28 Participants
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Tai Chi: Yang Style Tai Chi
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Health Education
n=12 Participants
twice weekly classes for 12 weeks
Health Education: Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Usual Medical Care
n=17 Participants
the usual care to which participants are entitled by their health insurance
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Age, Continuous
|
73.2 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
73.6 Years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
71.8 Years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
72.9 Years
STANDARD_DEVIATION 5.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
12 participants
n=7 Participants
|
17 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Roland-Morris Disability Measure Questionnaire
|
11.4 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
11.7 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
10.8 units on a scale
STANDARD_DEVIATION 4.2 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, 12 monthsThe score of the Roland-Morris Disability Questionnaire (RDMQ) is the total number of items checked, from a minimum of 0 to a maximum of 24, with a higher score indicating a higher experience of disability from back pain. The timeframe of the RMDQ is how a person feels within the last 7 days. Change was calculated as the value of the time point (3, 6, or 12 months) minus baseline
Outcome measures
| Measure |
Tai Chi
n=27 Participants
twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
Tai Chi: Yang Style Tai Chi
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Health Education
n=10 Participants
twice weekly classes for 12 weeks
Health Education: Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
Usual Medical Care
n=16 Participants
the usual care to which participants are entitled by their health insurance
Usual Medical Care: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
|
|---|---|---|---|
|
Change in Roland Morris Disability Questionnaire Score
3 Months
|
-4.38 units on a scale
Interval -5.81 to -2.96
|
-0.12 units on a scale
Interval -2.58 to 2.93
|
0.18 units on a scale
Interval -2.58 to 2.93
|
|
Change in Roland Morris Disability Questionnaire Score
6 Months
|
-3.64 units on a scale
Interval -5.64 to -1.65
|
-1.92 units on a scale
Interval -3.73 to -0.11
|
-2.39 units on a scale
Interval -4.79 to 0.01
|
|
Change in Roland Morris Disability Questionnaire Score
12 Months
|
-5.20 units on a scale
Interval -7.11 to -3.29
|
-0.82 units on a scale
Interval -3.04 to 1.4
|
-2.89 units on a scale
Interval -4.74 to -1.04
|
Adverse Events
Tai Chi
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Medical Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place