Clinical trial NCT03502187: Subacute Low Back Pain in Active Duty
Official title: Home-based Approaches for Subacute Low Back Pain in Active Duty: Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Low Back Pain
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Blanchfield Army Community Hospital
First posted: 2018-04-18
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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). The central hypothesis is that the NMES with PCM core strength training and PEP with PCM will show significantly greater improvements in muscle strength, pain, mobility/function, daily activity and quality of life (QOL) than PCM alone in military members with low back pain lasting three to eighteen weeks. The rationale for this study is that increasing torso muscle strength and decreasing pain through strength training exercises will significantly improve mobility, physical activity, QOL and reduce disability. Such outcomes could ultimately result in improved deployability, retention of military personnel and decreased economic costs in this population. The specific aims will be to determine whether the two treatment régimes 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. After consent and baseline testing, active duty male and female subjects, ages 18 to \<45, (n=135) with LBP will be randomly assigned to one of the three groups. Each of the two treatment arms will be supplemented by PCM and compared to a group receiving standard PCM alone. All groups will receive nine weeks of home therapy. Using longitudinal mixed regression models, differences in time trends for the outcome variables among controls and those in the treatment groups will be examined. In these regression analyses, the important primary measures will be expressed as a function of time, treatment group, and group-by-time interactions, while controlling for important covariates. Positive results could translate into accelerated rehabilitation, decreased symptoms and lower medical costs with better patient outcomes.

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 \<45 years;
* ability to provide freely given informed consent.

Exclusion Criteria:

Those who might be at risk of adverse outcomes from the study interventions will be excluded. This includes individuals with

* recurrence of LBP that is less than 3 months from prior episode;
* a significant co-morbid medical condition (such as severe hypertension, neurological disorder or pacemaker/defibrillator) in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
* previous back surgeries;
* inability or unwillingness to participate in an exercise or strengthening program;
* clinical evidence of a lumbar radiculopathy;
* inability to speak and/or read English;
* pregnancy;
* vision impairment, where participant is classified as legally blind;
* unwillingness to accept random assignment; or
* a score \>=23 on Center for Epidemiological Studies-Depression scale.

Primary outcomes:
measure: Lower Back Strength-Extension
timeFrame: 0, 3, 6, and 9 weeks
measure: Lower Back Strength-Flexion
timeFrame: 0, 3, 6, and 9 weeks
Secondary outcomes:
measure: Current Pain Severity
timeFrame: 0, 3, 6, 9 Weeks
measure: Impact of Bodily Pain on Normal Work Measured by SF12v2
timeFrame: 0, 3, 6, 9 Weeks
measure: Physical Activity
timeFrame: 0, 3, 6, 9 Weeks
measure: Mobility/Function Measured by the 2-minute Push-up Test
timeFrame: 0, 3, 6, 9 Weeks
measure: Mobility/Function Measured by the 2-minute Sit-up Test
timeFrame: 0, 3, 6, 9 Weeks
measure: Mobility/Function Measured by the 6-minute Walk Test
timeFrame: 0, 3, 6, 9 Weeks
measure: Depressive Symptoms-Center for Epidemiologic Studies Depression (CES-D) Scale
timeFrame: 0, 3, 6, 9 Weeks
Other outcomes:
Locations:
city: Fort Campbell North
country: United States
facility: Blanchfield Army Community Hospital (BACH)
state: Kentucky
Study officials:
affiliation: University of Tennessee
name: Laura A Talbot, PhD, EdD, RN
role: PRINCIPAL_INVESTIGATOR
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