NCT01221233

Investigation of Trunk Muscle Size and Function in Older Adults With Chronic Low Back Pain

Completed NA Results posted Last updated 28 October 2019

What this trial tests

NA trial testing Neuromuscular Electrical Stimulation in Low Back Pain in 38 participants. Completed in 22 November 2011.

Timeline

14 February 2011

Primary endpoint
22 November 2011

22 November 2011

Quick facts

Lead sponsor	University of Delaware
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	14 February 2011
Primary completion	22 November 2011
Estimated completion	22 November 2011
Sites	1 location across United States

Drugs / interventions tested

• Neuromuscular Electrical Stimulation
• Moist Heat

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

University of Delaware

Who can join

Adults 60 to 85, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Percent Change From Baseline in L4 Paraspinal Cross-Sectional Area Asymmetry at 6 Weeks Between Intervention Arms Primary · Baseline and 6 Weeks

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.

Group	Value	95% CI
NMES AND Stabilization Exercises	0	-57.1 – 104.3
Moist Heat AND Stabilization Exercises	-17.6	-51.1 – 250.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline, 6 weeks of intervention, and 6-week follow-up.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NMES AND Stabilization Exercises

Serious: 0/18 (0%)

Deaths: 0/18

Moist Heat AND Stabilization Exercises

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	NMES AND Stabilization Exe…	Moist Heat AND Stabilizati…
Pruritus	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT01221233 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.