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Rehabilitative Ultrasound Imaging (US) is a procedure used to evaluate skeletal muscle size and function to inform clinical practice. US has been shown to be a reliable and valid tool for measuring changes in trunk muscle (i.e. abdominal and back muscle) size and activity during sub-maximal contractions in younger populations. Younger adults with low back pain as compared with healthy adults without pain demonstrate smaller back muscle size, lower back muscle activity, and greater back muscle asymmetry (differences in right side compared with left side).
No trials are published evaluating muscle adaptations using US in response to clinical treatments for low back pain in the older adult population. Increased muscle size and improved muscle symmetry have been reported in younger adults with low back pain who participate in low back stabilization exercises. These exercises use voluntary contractions of the back muscles with prolonged hold times and low loads. Neuromuscular Electrical Stimulation (NMES) is a treatment modality that increases muscle activity when voluntary activity is impaired and increases muscle size. Most studies assessing muscle size and activity in response to NMES have been conducted in the knee muscles (i.e. the quadriceps), while the impact of NMES on the back muscles remains relatively unexplored. Given the potential to evaluate back muscle size and activity with US, this assessment tool may be used to document muscle adaptations to a clinical intervention in older adults with low back pain.
The purpose of this study is to conduct a 6-week clinical trial to determine if NMES plus lumbar stabilization exercises (i.e. NMES AND Stabilization Exercises) is superior to lumbar stabilization exercises (i.e. Moist Heat AND Stabilization Exercises) for improving back muscle size, activity, and side-to-side (i.e. right side versus left side) symmetry in older adults with chronic low back pain (i.e. low back pain of greater than 3 months). Muscle size, activity, and symmetry will be assessed using US before and after the treatments to determine if the treatments positively impact muscle. Secondary clinical measures of success will include improvements in physical, psychological, and social function pre- to post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES AND Stabilization Exercises | Experimental | Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises |
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| Moist Heat AND Stabilization Exercises | Active Comparator | Moist Heat and Lumbar Stabilization Exercises |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Electrical Stimulation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms | 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. | Baseline and 6 Weeks |
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Inclusion Criteria: This study will use a sample consisting of 36, English-speaking and English-reading, older male and female adults (ages 60-85 years) with chronic low back pain, i.e. pain of greater than 3 months duration. During the examination, potential participants must have 2/4 of the following for inclusion, based on previous work by Hicks et al, which outlined clinical predictors of success with a trunk muscle stabilization exercise program:
Exclusion Criteria: Exclusion criteria for participants includes (1) history of low back surgery; (2) recent trauma (i.e. motor vehicle accident, fall, etc. ); (3) receipt of services for low back pain within the last 6 months; (4) non-ambulatory or severely impaired mobility (i.e. use of an assistive device greater than a cane); (5) severe hearing or visual impairment; (6) non-mechanical low back pain; (7) neurological disorder; (8) presence of an acute illness; (9) diagnosis of scoliosis; (10) symptoms related to the back below the knee; (11) presence of a pacemaker; (12) participation in R21 clinical trial ongoing at the University of Delaware Physical Therapy Clinic; or (13) the inability to participate in the study for the full six weeks for any known reason (i.e. moving away, extended vacation). Potential participants will also be excluded if during the evaluation any of the following are found:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19716 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms | 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. | Analyses were only completed on participants who completed the randomized clinical trial. | Posted | Median | Inter-Quartile Range | % change | Baseline and 6 Weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NMES AND Stabilization Exercises | Neuromuscular Electrical Stimulation (NMES) and Lumbar Stabilization Exercises |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Lack of long-term follow-up; short-duration intervention may have been insufficient for muscle change
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaclyn Megan Sions, PhD, DPT, PT | University of Delaware, Department of Physical Therapy | 302-831-7231 | megsions@udel.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2010 | Jun 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Moist Heat | Other | 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). |
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| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Modified Oswestry Disability Index | A self-report questionnaire evaluating low back pain-related disability, where higher scores indicate greater disability. The total score is reported from 0-100%. | Mean | Standard Deviation | % |
|
| Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale | A self-report questionnaire evaluating fear-related to physical activity, where higher scores are indicative of greater fear that activity may make back pain worse. Physical activity subscale scores range from 0-24. | Mean | Standard Deviation | scores on a scale |
|
| Left L4/5 Lumbar Multifidus Activity | Lumbar multifidus activity is obtained from ultrasound imaging using brightness-mode, where two images, resting and contracted are obtained side-by-side. Measurements are obtained from the facet joint to the last pixel before the muscle's fascial line. Measurements are used in the following calculation to determine muscle activity: (contracted thickness-resting thickness)/resting thickness. Results are reported for the average of 3 sets of images as a percentage, where higher percentages indicate greater muscle activity. Percentages may range from 0% (i.e. no activity) to 100%. | Mean | Standard Deviation | percentage of activity |
|
| Right L4/5 Lumbar Multifidus Activity | Lumbar multifidus activity is obtained from ultrasound imaging using brightness-mode, where two images, resting and contracted are obtained side-by-side. Measurements are obtained from the facet joint to the last pixel before the muscle's fascial line. Measurements are used in the following calculation to determine muscle activity: (contracted thickness-resting thickness)/resting thickness. Results are reported for the average of 3 sets of images as a percentage, where higher percentages indicate greater muscle activity. Percentages may range from 0% (i.e. no activity) to 100%. | Mean | Standard Deviation | percentage of activity |
|
| Left L4 Paraspinal Muscle Size | Paraspinal muscle size is obtained from ultrasound imaging using brightness-mode, where the multifidus and longissimus are imaged just adjacent to the spinous process. Cross-sectional measurements are obtained by tracing just insides the muscle fascial lines. Measurements from 3 separate images were averaged. Greater sizes are generally better. Muscle size varies by vertebral level and by other factors, such as sex and body mass. Typical values have not been reported for this age-group. | Mean | Standard Deviation | cm2 |
|
| Right L4 Paraspinal Muscle Size | Paraspinal muscle size is obtained from ultrasound imaging using brightness-mode, where the multifidus and longissimus are imaged just adjacent to the spinous process. Cross-sectional measurements are obtained by tracing just insides the muscle fascial lines. Measurements from 3 separate images were averaged. Greater sizes are generally better. Muscle size varies by vertebral level and by other factors, such as sex and body mass. Typical values have not been reported for this age-group. | Mean | Standard Deviation | cm2 |
|
| L4 Paraspinal Cross-Sectional Area Asymmetry | Paraspinal muscle size is obtained from ultrasound imaging using brightness-mode, where the multifidus and longissimus are imaged just adjacent to the spinous process. Cross-sectional measurements are obtained by tracing just insides the muscle fascial lines. Side-to-side asymmetry was calculated as percent side-to-side difference = [(largest value/smallest value)*100]-100), so 0% indicates right and left paraspinal muscles are equal. Typical cross-sectional area asymmetry in this age group is unknown, but theoretically greater symmetry (i.e. lower percentages) would be ideal. | Mean | Standard Deviation | percent asymmetry |
|
| OG001 | Moist Heat AND 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 20 minutes of moist heat to the low back region. |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Moist Heat AND Stabilization Exercises | Moist Heat and Lumbar Stabilization Exercises | 0 | 20 | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |