Trial Outcomes & Findings for Mechanisms of Specific Trunk Exercises in Low Back Pain (NCT NCT01362049)
NCT ID: NCT01362049
Last Updated: 2017-06-05
Results Overview
Disability; Sacle 0-100% Lower score is considered better/improved
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
Baseline and 7 weeks
Results posted on
2017-06-05
Participant Flow
Participant milestones
| Measure |
'Eligible' Subject Group - MSI Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment
|
'Eligible' Subject Group - STAB Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment
|
'Ineligible' Subject Group - MSI Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received MSI- matched treatment
|
'Ineligible' Subject Group - STAB Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received STAB treatment
|
|---|---|---|---|---|
|
Follow-Up at 7 Weeks
STARTED
|
26
|
19
|
32
|
25
|
|
Follow-Up at 7 Weeks
Randomized and Started PT Treatment
|
26
|
18
|
32
|
25
|
|
Follow-Up at 7 Weeks
COMPLETED
|
23
|
16
|
30
|
24
|
|
Follow-Up at 7 Weeks
NOT COMPLETED
|
3
|
3
|
2
|
1
|
|
Follow-Up at 52 Weeks (12 Months)
STARTED
|
23
|
16
|
30
|
24
|
|
Follow-Up at 52 Weeks (12 Months)
COMPLETED
|
18
|
13
|
28
|
21
|
|
Follow-Up at 52 Weeks (12 Months)
NOT COMPLETED
|
5
|
3
|
2
|
3
|
Reasons for withdrawal
| Measure |
'Eligible' Subject Group - MSI Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment
|
'Eligible' Subject Group - STAB Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment
|
'Ineligible' Subject Group - MSI Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received MSI- matched treatment
|
'Ineligible' Subject Group - STAB Treatment
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received STAB treatment
|
|---|---|---|---|---|
|
Follow-Up at 7 Weeks
Lost to Follow-up
|
3
|
3
|
2
|
1
|
|
Follow-Up at 52 Weeks (12 Months)
Lost to Follow-up
|
5
|
3
|
2
|
3
|
Baseline Characteristics
Mechanisms of Specific Trunk Exercises in Low Back Pain
Baseline characteristics by cohort
| Measure |
'Eligible' Subject Group - MSI Treatment
n=26 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-match treatment
|
'Eligible' Subject Group - STAB Treatment
n=19 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment
|
'Ineligible' Subject Group - MSI Treatment
n=32 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received MSI-match treatment
|
'Ineligible' Subject Group - STAB Treatment
n=25 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.
Received STAB treatment
|
Total
n=102 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
37.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
44.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
41.5 years
STANDARD_DEVIATION 10.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
19 participants
n=7 Participants
|
32 participants
n=5 Participants
|
25 participants
n=4 Participants
|
102 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 weeksPopulation: Participants with available data are included
Disability; Sacle 0-100% Lower score is considered better/improved
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=23 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=16 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=30 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=23 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in Oswestry Disability Scale (0-100%)
|
-8.26 units on a scale
Standard Deviation 7.94
|
-7.75 units on a scale
Standard Deviation 8.54
|
-8.00 units on a scale
Standard Deviation 10.47
|
-9.48 units on a scale
Standard Deviation 12.02
|
PRIMARY outcome
Timeframe: Baseline and 12 MonthsPopulation: Participants with available data are included
Disability; Sacle 0-100% Lower score is considered better/improved
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=18 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=13 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=28 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=20 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in Oswestry Disability Scale (0-100%)
|
-8.8 units on a scale
Standard Deviation 13.8
|
-14.2 units on a scale
Standard Deviation 8.9
|
-10.1 units on a scale
Standard Deviation 9.9
|
-9.7 units on a scale
Standard Deviation 11.2
|
PRIMARY outcome
Timeframe: Baseline and 7 weeksPopulation: Participants with available data are included
Current Pain Scale 0-10 Lower score is better/improved
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=21 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=14 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=30 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=25 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
|
-.62 units on a scale
Standard Deviation 2.56
|
-1 units on a scale
Standard Deviation 1.62
|
-1.50 units on a scale
Standard Deviation 1.61
|
-.92 units on a scale
Standard Deviation 1.55
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: Participants with available data are included
Current Pain Scale 0-10 Lower score is better/improved
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=17 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=9 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=23 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=20 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in Numeric Pain Rating Scale (0-10 Points)
|
.18 units on a scale
Standard Deviation 3.68
|
-1.56 units on a scale
Standard Deviation 1.94
|
-1.35 units on a scale
Standard Deviation 2.06
|
-1.25 units on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: Participants with available data are included
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=21 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=15 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=30 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=24 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in SF-36 Health Survey (0 - 100 Points)
|
4.40 units on a scale
Standard Deviation 6.27
|
3.99 units on a scale
Standard Deviation 5.99
|
3.34 units on a scale
Standard Deviation 4.87
|
1.32 units on a scale
Standard Deviation 6.09
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Participants with available data are included
Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=16 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=13 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=28 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=20 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in SF-36 Health Survey (0-100 Points)
|
3.16 units on a scale
Standard Deviation 4.48
|
5.68 units on a scale
Standard Deviation 6.25
|
2.72 units on a scale
Standard Deviation 6.11
|
2.97 units on a scale
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: Participants with available data are included
fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=23 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=16 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=30 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=25 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
|
-0.65 units on a scale
Standard Deviation 3.8
|
-0.53 units on a scale
Standard Deviation 3.8
|
-0.5 units on a scale
Standard Deviation 5.2
|
-1.15 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsPopulation: Participants with available data are included
fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty
Outcome measures
| Measure |
'Eligible' Subject Group - MSI
n=18 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
|
'Eligible' Subject Group - STAB
n=12 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:
1. straight leg raise \> 90 degrees
2. aberrant trunk movement with trunk forward flexion
3. positive prone instability test AND/OR
4. passive lumbar mobility testing that is judged to be hypermobile at any level.
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
'Ineligible' Subject Group -MSI
n=28 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
|
'Ineligible' Subject Group - STAB
n=20 Participants
Subjects between the ages of 21-55 years with low back pain \>12 months who are not eligible for the TBC-based stabilization exercises based on current criteria
Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
|
|---|---|---|---|---|
|
Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)
|
-3.1 units on a scale
Standard Deviation 4.8
|
0.6 units on a scale
Standard Deviation 4.5
|
-2.9 units on a scale
Standard Deviation 5.3
|
-1.6 units on a scale
Standard Deviation 6.1
|
Adverse Events
'Eligible' Subject Group - MSI Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
'Eligible' Subject Group - STAB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
'Ineligible' Subject Group - MSI Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
'Ineligible' Subject Group - STAB Treatment
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
Dr. Sharon M. Henry
University of Vermont Medical Center, Burlington, VT
Phone: (802) 847-7633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place