Trial Outcomes & Findings for Study to Evaluate the Effectiveness of Orthopedic Spinal Supports in the Treatment of Low Back Pain (NCT NCT00553540)
NCT ID: NCT00553540
Last Updated: 2019-11-25
Results Overview
numeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24. Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
6 months
Results posted on
2019-11-25
Participant Flow
Participant milestones
| Measure |
Control Group
Patients in this group will receive physical therapy and posture education for low back pain
|
Test Group
Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain
Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Control Group
Patients in this group will receive physical therapy and posture education for low back pain
|
Test Group
Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain
Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
|
|---|---|---|
|
Overall Study
discharged after first visit
|
2
|
5
|
Baseline Characteristics
We did not have the age for several participants and were regarded as missing values when running the data in SPSS
Baseline characteristics by cohort
| Measure |
Control Group
n=25 Participants
Patients in this group will receive physical therapy and posture education for low back pain
|
Test Group
n=25 Participants
Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain
Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.48 years
STANDARD_DEVIATION 9.462 • n=23 Participants • We did not have the age for several participants and were regarded as missing values when running the data in SPSS
|
42.95 years
STANDARD_DEVIATION 11.781 • n=20 Participants • We did not have the age for several participants and were regarded as missing values when running the data in SPSS
|
45.61 years
STANDARD_DEVIATION 10.98 • n=43 Participants • We did not have the age for several participants and were regarded as missing values when running the data in SPSS
|
|
Sex: Female, Male
Female
|
13 Participants
n=23 Participants • the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
14 Participants
n=20 Participants • the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
27 Participants
n=43 Participants • the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
|
Sex: Female, Male
Male
|
10 Participants
n=23 Participants • the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
6 Participants
n=20 Participants • the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
16 Participants
n=43 Participants • the analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
|
Body Mass Index
|
28.326 kg/m^2
STANDARD_DEVIATION 6.498 • n=23 Participants • The analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
28.686 kg/m^2
STANDARD_DEVIATION 5.997 • n=20 Participants • The analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
28.49 kg/m^2
STANDARD_DEVIATION 6 • n=43 Participants • The analyzed number of participants is different because, complete data was only collected for the numbers given. The other seven had incomplete data
|
PRIMARY outcome
Timeframe: 6 monthsnumeric pain scale was used to determine pain at 1 week intervals starting from week 1 to week 24. Pain scores were determined by the numeric pain score of 1 to 10 (1 being the least painful to 10 being the highest level of pain) then summed up and averaged at 24 time points at 1 week intervals starting from week 1 to week 24.
Outcome measures
| Measure |
Control Group
n=23 Participants
Patients in this group will receive physical therapy and posture education for low back pain
|
Test Group
n=20 Participants
Patients in this group will receive spinal / back supports in addition to physical therapy and posture education for low back pain
Back supports: The spinal / back supports are made of polymer shield covered by fabric and foam to be used externally to relieve back pain and offer spinal support. They are to be placed in the chair used in workstation related jobs.
|
|---|---|---|
|
Change in Low Back Pain
|
2.58 units on a scale
Interval 1.0 to 10.0
|
1.80 units on a scale
Interval 1.0 to 10.0
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Test Group
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