Trial Outcomes & Findings for Investigation of Trunk Muscle Size and Function in Older Adults With Chronic Low Back Pain (NCT NCT01221233)
NCT ID: NCT01221233
Last Updated: 2019-10-28
Results Overview
Percent change (baseline-6 weeks)/baseline X100% was calculated for each participant in each intervention arm and then these differences were compared using a Mann-Whitney U test since data did not meet parametric assumptions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline and 6 Weeks
Results posted on
2019-10-28
Participant Flow
Participant milestones
| Measure |
NMES AND Stabilization Exercises
Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises
Neuromuscular Electrical Stimulation: Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock.
The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).
|
Moist Heat AND Stabilization Exercises
Moist Heat and Lumbar Stabilization Exercises
Moist Heat: For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant.
The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
NMES AND Stabilization Exercises
Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises
Neuromuscular Electrical Stimulation: Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock.
The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).
|
Moist Heat AND Stabilization Exercises
Moist Heat and Lumbar Stabilization Exercises
Moist Heat: For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant.
The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Investigation of Trunk Muscle Size and Function in Older Adults With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
NMES AND Stabilization Exercises
n=15 Participants
Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises
Neuromuscular Electrical Stimulation: Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock.
The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).
|
Moist Heat AND Stabilization Exercises
n=19 Participants
Moist Heat and Lumbar Stabilization Exercises
Moist Heat: For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant.
The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 7.6 • n=93 Participants
|
71.3 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
71.6 years
STANDARD_DEVIATION 7.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
19 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Modified Oswestry Disability Index
|
25.5 %
STANDARD_DEVIATION 8.7 • n=93 Participants
|
22.2 %
STANDARD_DEVIATION 7.9 • n=4 Participants
|
23.6 %
STANDARD_DEVIATION 8.3 • n=27 Participants
|
|
Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale
|
13.7 scores on a scale
STANDARD_DEVIATION 4.4 • n=93 Participants
|
15.2 scores on a scale
STANDARD_DEVIATION 6.5 • n=4 Participants
|
14.5 scores on a scale
STANDARD_DEVIATION 5.7 • n=27 Participants
|
|
Left L4/5 Lumbar Multifidus Activity
|
11.1 percentage of activity
STANDARD_DEVIATION 5.6 • n=93 Participants
|
12.3 percentage of activity
STANDARD_DEVIATION 4.9 • n=4 Participants
|
11.8 percentage of activity
STANDARD_DEVIATION 5.2 • n=27 Participants
|
|
Right L4/5 Lumbar Multifidus Activity
|
9.5 percentage of activity
STANDARD_DEVIATION 6.0 • n=93 Participants
|
11.8 percentage of activity
STANDARD_DEVIATION 4.4 • n=4 Participants
|
10.8 percentage of activity
STANDARD_DEVIATION 5.3 • n=27 Participants
|
|
Left L4 Paraspinal Muscle Size
|
11.6 cm2
STANDARD_DEVIATION 2.0 • n=93 Participants
|
12.0 cm2
STANDARD_DEVIATION 2.0 • n=4 Participants
|
11.9 cm2
STANDARD_DEVIATION 2.0 • n=27 Participants
|
|
Right L4 Paraspinal Muscle Size
|
11.1 cm2
STANDARD_DEVIATION 2.1 • n=93 Participants
|
11.4 cm2
STANDARD_DEVIATION 1.8 • n=4 Participants
|
11.2 cm2
STANDARD_DEVIATION 1.9 • n=27 Participants
|
|
L4 Paraspinal Cross-Sectional Area Asymmetry
|
14.0 percent asymmetry
STANDARD_DEVIATION 13.3 • n=93 Participants
|
10.1 percent asymmetry
STANDARD_DEVIATION 7.8 • n=4 Participants
|
11.8 percent asymmetry
STANDARD_DEVIATION 10.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Analyses were only completed on participants who completed the randomized clinical trial.
Percent change (baseline-6 weeks)/baseline X100% was calculated for each participant in each intervention arm and then these differences were compared using a Mann-Whitney U test since data did not meet parametric assumptions.
Outcome measures
| Measure |
NMES AND Stabilization Exercises
n=15 Participants
Neuromuscular Electrical Stimulation (NMES) and Lumbar Stabilization Exercises
Participants received a physical therapy intervention 2 times per week for 6 weeks that consisted of a lumbar stabilization exercise program targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees) followed by NMES set to portable 300PV unit by EMPI (St. Paul, MN) was set to the following: 50 bursts per second, 12 seconds of contraction, 50 seconds of rest, a 2 second ramp, 400 microseconds, and a treatment time of 20 minutes
|
Moist Heat AND Stabilization Exercises
n=19 Participants
Participants received a physical therapy intervention 2 times per week for 6 weeks that consisted of a lumbar stabilization exercise program targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees) followed by 20 minutes of moist heat to the low back region.
|
|---|---|---|
|
Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms
|
0 % change
Interval -57.1 to 104.3
|
-17.6 % change
Interval -51.1 to 250.0
|
Adverse Events
NMES AND Stabilization Exercises
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Moist Heat AND Stabilization Exercises
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NMES AND Stabilization Exercises
n=18 participants at risk
Neuromuscular Electrical Stimulation (NMES) and Lumbar Stabilization Exercises
|
Moist Heat AND Stabilization Exercises
n=20 participants at risk
Moist Heat and Lumbar Stabilization Exercises
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • Baseline, 6 weeks of intervention, and 6-week follow-up.
Adverse events were reported by study personnel in accordance with the University of Delaware Institutional Review Board for Human Subjects Research. Adverse event definitions as described in the Common Terminology Criteria for Adverse Events (CTCAE) from the National Institutes of Health are used for reporting.
|
0.00%
0/20 • Baseline, 6 weeks of intervention, and 6-week follow-up.
Adverse events were reported by study personnel in accordance with the University of Delaware Institutional Review Board for Human Subjects Research. Adverse event definitions as described in the Common Terminology Criteria for Adverse Events (CTCAE) from the National Institutes of Health are used for reporting.
|
Additional Information
Dr. Jaclyn Megan Sions, PhD, DPT, PT
University of Delaware, Department of Physical Therapy
Phone: 302-831-7231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place