N/A
N=128
Subacute Low Back Pain in Active Duty
Subacute Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03502187 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Lower Back Strength-Extension — 54.5; 50.2; 49.2; 57.5 kg-Force
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Progressive Exercise Plan (Behavioral); NeuromuscularElectricalStimulation(NMES) (Device); Primary Care Management (PCM) (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Tennessee
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lower Back Strength-Extension |
54.5; 50.2; 49.2; 57.5; 61.4; 54.6 | — |
| PRIMARY Lower Back Strength-Flexion |
51.6; 48.8; 43.7; 52.1; 57.9; 47.7 | — |
| SECONDARY Current Pain Severity |
4.43; 4.57; 4.78; 3.88; 4.54; 4.47 | — |
| SECONDARY Impact of Bodily Pain on Normal Work Measured by SF12v2 |
53.6; 44; 47.6; 59.0; 58.8; 55.9 | — |
| SECONDARY Physical Activity |
2733; 3005; 2912; 2691; 2950; 2809 | — |
| SECONDARY Mobility/Function Measured by the 2-minute Push-up Test |
46.9; 41.1; 43.7; 46.0; 40.3; 47.4 | — |
| SECONDARY Mobility/Function Measured by the 2-minute Sit-up Test |
44.4; 35.5; 41.5; 44.9; 38.7; 43.2 | — |
| SECONDARY Mobility/Function Measured by the 6-minute Walk Test |
1940; 1868; 1858; 2020; 1889; 1882 | — |
| SECONDARY Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale |
6.84; 6.05; 6.26; 7.78; 6.46; 7.12 | — |
Summary
The overall objective of this project is to compare three home-managed treatment regimens for subacute low back pain: Progressive Exercise Plan (PEP), NMES (neuromuscular electrical stimulation) core strength training and standard primary care management (PCM). Each of the two treatment arms will be supplemented by Primary Care Management. The specific aim of the study is to determine whether the two treatment regimes are significantly more efficacious than standard PCM alone in improving lower back muscle strength, daily physical activity, physical function, quality of life, and symptoms associated with subacute LBP.
Eligibility Criteria
Inclusion Criteria: Diagnosed with low back pain, categorized as lumbago or unspecified backache;
- greater than 3 weeks and less than 18 weeks since the onset of the episode of LBP;
- active duty military service member at the time of diagnosis;
- age ≥18 and =23 on Center for Epidemiological Studies-Depression scale.
Data sourced from ClinicalTrials.gov (NCT03502187). 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.