Trial Outcomes & Findings for Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain (NCT NCT01611792)
NCT ID: NCT01611792
Last Updated: 2017-10-18
Results Overview
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Baseline and 11 weeks
Results posted on
2017-10-18
Participant Flow
Participant milestones
| Measure |
Low Back Pain
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Initial Period: Time 0
STARTED
|
29
|
29
|
|
Initial Period: Time 0
COMPLETED
|
17
|
20
|
|
Initial Period: Time 0
NOT COMPLETED
|
12
|
9
|
|
Follow-up: at 11 Weeks
STARTED
|
17
|
20
|
|
Follow-up: at 11 Weeks
COMPLETED
|
17
|
20
|
|
Follow-up: at 11 Weeks
NOT COMPLETED
|
0
|
0
|
|
Followup: at 6 Months
STARTED
|
17
|
20
|
|
Followup: at 6 Months
COMPLETED
|
11
|
7
|
|
Followup: at 6 Months
NOT COMPLETED
|
6
|
13
|
Reasons for withdrawal
| Measure |
Low Back Pain
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Initial Period: Time 0
unable to schedule 10 consecutive appts
|
12
|
9
|
|
Followup: at 6 Months
Lost to Follow-up
|
6
|
13
|
Baseline Characteristics
Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain
Baseline characteristics by cohort
| Measure |
Stabilization
n=17 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=20 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
Total
n=37 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
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
40.9 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Numeric Pain Index
|
3.7 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.5 • n=7 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Modified Oswestry Disability Index
|
22.3 units on a scale
STANDARD_DEVIATION 9.7 • n=5 Participants
|
20.1 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 11 weeksPopulation: Based on data reported and available
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
Outcome measures
| Measure |
Stabilization
n=17 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=20 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
|
-11.06 units on a scale
Standard Deviation 7.45
|
-9.10 units on a scale
Standard Deviation 10.27
|
PRIMARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Based on data reported and available
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Outcome measures
| Measure |
Stabilization
n=11 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=7 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
|
-10.73 units on a scale
Standard Deviation 9.73
|
-0.29 units on a scale
Standard Deviation 12.78
|
PRIMARY outcome
Timeframe: 11 Weeks and 6 MonthsPopulation: Based on data reported and available
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Outcome measures
| Measure |
Stabilization
n=11 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=7 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
|
0.55 units on a scale
Standard Deviation 4.12
|
4.29 units on a scale
Standard Deviation 6.58
|
PRIMARY outcome
Timeframe: Baseline and 11 weeksPopulation: Based on data reported and available
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Outcome measures
| Measure |
Stabilization
n=12 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=17 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
|
-0.67 units on a scale
Standard Deviation 2.19
|
-1.76 units on a scale
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: Based on data reported and available
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Outcome measures
| Measure |
Stabilization
n=10 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=6 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
|
-0.2 units on a scale
Standard Deviation 1.6
|
2.2 units on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: 11 weeks and 6 monthsPopulation: Based on data reported and available
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Outcome measures
| Measure |
Stabilization
n=10 Participants
Stabilization
Stabilization exercise protocol: 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 as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
|
Strengthening and Conditioning
n=6 Participants
Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
|
|---|---|---|
|
Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
|
-0.2 units on a scale
Standard Deviation 1.6
|
2.2 units on a scale
Standard Deviation 2.1
|
Adverse Events
Stabilization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Strengthening and Conditioning
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: 802 847-6733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place