View Clinical Trial (Medical Research Study)
Lumbar Stabilization Exercises and Neuromuscular Electrical Stimulation: An Investigation of Muscle Size and Function in Older Adults With Chronic Low Back Pain
| City: |
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Newark |
| State: |
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Delaware |
| Zip Code: |
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19716 |
| Conditions: |
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Low Back Pain |
| Purpose: |
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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 is superior to lumbar 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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| Study Summary: |
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| Criteria: |
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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:
1. Fear-Avoidance Beliefs Questionnaire (FABQ) Physical Activity Sub-Scale score ≥9:
The FABQ is a measure of an individual's beliefs regarding the impact of physical
activity and work on his/her low back pain. The FABQ is comprised of two sub-scales:
physical activity and work. Higher FABQ scores have been shown to predict pain and
disability in individuals with chronic low back pain.
2. Aberrant Movement: Aberrant movement may be classified as any one of the following:
(1) an "instability catch", defined as deviation from the plane of movement during
flexion or extension; (2) "thigh climbing", which is defined as using the hands and
pushing on the thighs to assist in obtaining an upright trunk position; (3) a
"painful arc of motion", when flexing or returning to upright from a flexed spinal
position; or (4) "reversal of the lumbopelvic rhythm", where the trunk is first
extended and then the hips and pelvis extend to bring the body upright from a flexed
position.
3. Posterior-to-Anterior Segmental Hypermobility: The participant will lie on his/her
stomach and the examiner will apply a posterior-to-anterior (back-to-front) force
over the spinous processes from S1 to T12 (just below the belt-line to the rib cage).
The available mobility will be graded hypermobile (too much motion), normal, or
hypomobile (too little motion).
4. Positive Prone Instability Test: The participant will lie on his/her stomach with the
legs off the edge of the table and the feet resting on the floor. The examiner will
apply a posterior-to-anterior pressure at each spinous process (T12-S1). Any
provocation of pain will require the participant to lift their legs off the floor
while the pressure is reapplied to the painful level. If the pain subsides with
elevation of the legs, this is considered a positive test.
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 UD PT 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:
1. score < 24 on the Folstein Mini-Mental State Examination (MMSE): As scores greater
than or equal to 24 may identify individuals who are cognitively intact, this
screening tool will exclude those older adults with questionable reliability (i.e.
consistency) on the self-report questionnaires secondary to cognitive impairment.
2. Modified Oswestry Low Back Pain Questionnaire (mOSW) score < 14 percent: This
questionnaire will exclude those individuals with chronic low back pain who
demonstrate minimal low back pain-related disability. Individuals with minimal
disability may not be representative of those seeking outpatient physical therapy
services for their back pain.
3. Facial Pain Scale-Revised (FPS-R) "worst" low back pain rating in last 24 hours of <
3/10: Pain rating ≥ 3/10 is being used in the hopes of recruiting a group of
individuals who may be representative of those likely to seek clinical services for
their low back pain. Also, all FPS-Rs ("current", "best", and "worst") will be used
to document the impact of treatment on self-reported pain.
4. Inability to tolerate lying on belly with legs straight: This is a requirement for
our standardized position for ultrasound.
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| NCT ID: |
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NCT01221233 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Newark, Delaware 19716
United States
J. Megan Sions, PT, DPT, OCS
Phone: 302-831-8893
Email: megsions@udel.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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