Trial Outcomes & Findings for Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care (NCT NCT03669354)
NCT ID: NCT03669354
Last Updated: 2021-09-23
Results Overview
1. Self-reported Quality of Life 2. Scale range- There are 12 questions with scales of categorical values. Corresponding numeric values will be given to each category. 3. Value range from "0" to "100" 4. Higher scores reflecting better outcomes.
Recruitment status
COMPLETED
Target enrollment
195 participants
Primary outcome timeframe
Base line. The survey (outcome measure) will be administered at at day one.
Results posted on
2021-09-23
Participant Flow
Participant milestones
| Measure |
Cohort SMT
Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
|
Cohort OAT
Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
|
SMTX
Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
|
OATX
Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
73
|
22
|
47
|
53
|
|
Overall Study
COMPLETED
|
73
|
22
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
Baseline characteristics by cohort
| Measure |
Cohort SMT
n=73 Participants
Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
|
Cohort OAT
n=22 Participants
Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
|
Cohort SMTX
n=47 Participants
Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
|
Cohort OATX
n=53 Participants
Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=71 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=19 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=45 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=50 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=185 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
|
Age, Continuous
|
78 years
STANDARD_DEVIATION 3.6 • n=73 Participants
|
78 years
STANDARD_DEVIATION 3.7 • n=22 Participants
|
78 years
STANDARD_DEVIATION 3.6 • n=47 Participants
|
77 years
STANDARD_DEVIATION 4.1 • n=53 Participants
|
78 years
STANDARD_DEVIATION 3.7 • n=195 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=73 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
0 Participants
Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
33 Participants
n=47 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
0 Participants
Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
87 Participants
n=120 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
|
Sex: Female, Male
Male
|
19 Participants
n=73 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
0 Participants
Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
14 Participants
n=47 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
0 Participants
Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
33 Participants
n=120 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here " 0"means data were not reported because cell numbers are suppressed by Medicare regulations
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=71 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=19 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=45 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=50 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
0 Participants
n=185 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=71 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
19 Participants
n=19 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
45 Participants
n=45 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
50 Participants
n=50 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
185 Participants
n=185 Participants • Based on Medicare CMS data reporting guidelines, we are required by Data Use Agreement to suppress the data with small cell numbers ( DUA #). Here Zero means data were not reported because cell numbers are suppressed by Medicare regulations.
|
PRIMARY outcome
Timeframe: Base line. The survey (outcome measure) will be administered at at day one.1. Self-reported Quality of Life 2. Scale range- There are 12 questions with scales of categorical values. Corresponding numeric values will be given to each category. 3. Value range from "0" to "100" 4. Higher scores reflecting better outcomes.
Outcome measures
| Measure |
Cohort SMT
n=73 Participants
Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
|
Cohort OAT
n=22 Participants
Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
|
Cohort SMTX
n=47 Participants
Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
|
Cohort OATX
n=53 Participants
Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
|
|---|---|---|---|---|
|
Self-reported QOL - Physical Health
|
41.7 units on a scale
Standard Deviation 11.2
|
28.8 units on a scale
Standard Deviation 9.2
|
31.8 units on a scale
Standard Deviation 8.7
|
32.9 units on a scale
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: Base line.The survey (outcome measure) will be administered at day one.1. Satisfaction with the Care 2. The survey measured satisfaction for both SMT and PDT on a scale from 0-10, "0" being very dissatisfied and "10" being very satisfied. The patients were also given an option to select 'not applicable' if they never experienced either PDT or SMT. 3. Higher numerical values indicate more satisfaction.
Outcome measures
| Measure |
Cohort SMT
n=73 Participants
Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
|
Cohort OAT
n=22 Participants
Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
|
Cohort SMTX
n=47 Participants
Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
|
Cohort OATX
n=53 Participants
Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
|
|---|---|---|---|---|
|
Satisfaction With Care
|
8.9 Score on a scale
Standard Deviation 1.7
|
7.2 Score on a scale
Standard Deviation 2.5
|
4.9 Score on a scale
Standard Deviation 3.33
|
8.2 Score on a scale
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: Base line.The survey (outcome measure) will be administered at at day one.Population: Not every participant responded to all the questions. Results account for missing data.
1. Beliefs about Treatments for Low Back Pain 2. Scale range- Categorical values of Strongly disagree, Disagree, Undecided, Agree, Strongly agree (corresponding to numeric value 1, 2, 3, 4, and 5). 3. For purposes of analysis, we combined the response options into the following three categories: "Disagree" (Strongly Disagree and Disagree), "Agree" (Strongly Agree and Agree), and "Undecided"(left as is). 4. For interpreting the results for this scale, we reported only the number of people who agreed with the statements.
Outcome measures
| Measure |
Cohort SMT
n=71 Participants
Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT
|
Cohort OAT
n=21 Participants
Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT
|
Cohort SMTX
n=46 Participants
Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management with OAT
|
Cohort OATX
n=51 Participants
Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management with SMT.
|
|---|---|---|---|---|
|
Beliefs Regarding Back Pain and Its Treatment
I have concerns about taking/having prescription drugs for my low back pain
|
53 participants number
|
5 participants number
|
23 participants number
|
29 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
Taking/having prescription drugs for low back pain makes a lot of sense
|
9 participants number
|
19 participants number
|
23 participants number
|
16 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
I think spinal manipulation is pretty useless for people with low back pain
|
5 participants number
|
5 participants number
|
41 participants number
|
10 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
Taking/having spinal manipulation for low back pain makes a lot of sense
|
68 participants number
|
7 participants number
|
33 participants number
|
46 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
I think taking prescription drugs are pretty useless for people with low back pain
|
34 participants number
|
19 participants number
|
14 participants number
|
15 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
I have concerns about taking/having spinal manipulation for my low back pain
|
49 participants number
|
12 participants number
|
6 participants number
|
8 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
I am confident prescription drugs would be suitable treatment for my low back pain.
|
7 participants number
|
19 participants number
|
23 participants number
|
12 participants number
|
|
Beliefs Regarding Back Pain and Its Treatment
I am confident spinal manipulation would be suitable treatment for my low back pain
|
64 participants number
|
5 participants number
|
31 participants number
|
41 participants number
|
Adverse Events
Cohort SMT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort OAT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort SMTX
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort OATX
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
Anupama Kizhakkeveettil
Southern California University Of Health Sciences
Phone: (562) 475-5158
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place