N/A
Completed N=30
Stabilization Exercises Alone vs Stabilization Exercises Plus Neuromuscular Electrical Stimulation in People With Chronic Low Back Pain
Source: ClinicalTrials.gov NCT02864732 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Tolerability of Electrical Stimulation (NMES) — 0; 5; 8; 0 Participants
Summary
The purpose of this study is to investigate the feasibility of applying neuromuscular electrical stimulation on the lumbar spine, to report how tolerable the intervention is, and whether the electrical stimulation improve pain, function and muscle strength.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability of Electrical Stimulation (NMES) |
0; 5; 8; 0; 3; 10 | — |
| PRIMARY Modified Oswestry Disability Questionnaire (MODQ) |
30.80; 30.52; 12.81; 14.49; 10.00; 13.24 | — |
| SECONDARY Numeric Pain Rating Scale (NPRS) |
4.44; 4.20; 2.07; 2.34; 1.63; 2.34 | — |
| SECONDARY Fear-avoidance Behavior Questionnaire |
12.33; 14.27; 8.41; 10.75; 12.20; 11.67 | — |
| SECONDARY Paraspinal Muscle Strength |
117.29; 154.49; 162.30; 175.80 | — |
| SECONDARY Patient Satisfaction Survey |
10; 8; 3; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Between 18 years of age and 60.
- Body Mass Index (BMI) of less than 34.
- Low Back Pain duration of 3 months or greater (chronic).
- Minimum pain level on Numeric Pain Rating Scale (NPRS) is 3 or greater.
- Minimum score of Modified Oswestry Disability Questionnaire (MODQ) is 20 or greater.
- Understands English
Exclusion Criteria
- Positive nerve root tension signs
- Progressive neurological deficit
- Positive Babinski sign.
- Sensory loss that is not in correspondence with dermatomal distribution or peripheral nerves.
- History of spinal surgery
- History of inflammatory joint disease
- Contraindications to physical exercise including history of cardiac disease or being told by a physician not to engage in physical exercise.
- Contraindications to NMES including cardiac pacemaker or skin allergy to adhesives
- History of metastatic cancer in previous 5 years or present treatment for cancer
- Women who indicate that they are pregnant or plan to become pregnant
Data sourced from ClinicalTrials.gov (NCT02864732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.