An interventional study of Neuromuscular Electrical Stimulation and Moist Heat in Low Back Pain, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-28.
Sponsored by University of Delaware · Not applicable, Interventional, and Treatment
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Neuromuscular Electrical Stimulation and Lumbar Stabilization Exercises
Other: Neuromuscular Electrical Stimulation
Moist Heat and Lumbar Stabilization Exercises
Other: Moist Heat
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).
Also known as: Lumbar Stabilization Exercises
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).
Also known as: Lumbar Stabilization Exercises
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.
Time frame: Baseline and 6 Weeks
| Milestone | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises |
|---|---|---|
| Started | 18 | 20 |
| Completed | 15 | 19 |
| Not completed | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
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.
| % change | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises |
|---|---|---|
| Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms | 0 (-57.1 to 104.3) | -17.6 (-51.1 to 250.0) |
Collected over Baseline, 6 weeks of intervention, and 6-week follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NMES AND Stabilization Exercises | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Moist Heat AND Stabilization Exercises | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 1/18 | 0/20 |
| Age, Continuous(years) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| Mean | 71.9 ± 7.6 | 71.3 ± 7.7 | 71.6 ± 7.6 |
| Sex: Female, Male(Participants) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| Female | 7 | 9 | 16 |
| Male | 8 | 10 | 18 |
| Race (NIH/OMB)(Participants) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 15 | 17 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| United States | 15 | 19 | 34 |
| Modified Oswestry Disability Index(%) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| Mean | 25.5 ± 8.7 | 22.2 ± 7.9 | 23.6 ± 8.3 |
| Fear-Avoidance Beliefs Questionnaire-Physical Activity Subscale(scores on a scale) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| Mean | 13.7 ± 4.4 | 15.2 ± 6.5 | 14.5 ± 5.7 |
| Left L4/5 Lumbar Multifidus Activity(percentage of activity) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| Mean | 11.1 ± 5.6 | 12.3 ± 4.9 | 11.8 ± 5.2 |
| Right L4/5 Lumbar Multifidus Activity(percentage of activity) | NMES AND Stabilization Exercises | Moist Heat AND Stabilization Exercises | Total |
|---|---|---|---|
| Mean | 9.5 ± 6.0 | 11.8 ± 4.4 | 10.8 ± 5.3 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Feb 2011 to primary completion in Nov 2011, 9 months.
Results were first posted in Oct 2019, 7 years 11 months after primary completion.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 9 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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