CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Neuromuscular Electrical Stimulation +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01221233
NCT01221233N/ACompleted

Lumbar Stabilization Exercises and Neuromuscular Electrical Stimulation: An Investigation of Muscle Size and Function in Older Adults With Chronic Low Back Pain

University of Delaware·interventional·Posted Oct 14, 2010·Updated Oct 28, 2019

In Brief

A clinical study evaluating Neuromuscular Electrical Stimulation and Moist Heat for Low Back Pain. Completed, enrolled 38 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 14, 2010
Enrollment StartFeb 14, 2011
Primary CompletionNov 22, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.7 years ago

Interventions

Neuromuscular Electrical Stimulationother

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 Heatother

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).