An interventional study of Standard Physical Therapy and Lumbar Extensor Strengthening plus Standard Physical Therapy in Chronic Low Back Pain (CLBP), sponsored by Brooke Army Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Brooke Army Medical Center · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine the effect of adding lumbar strengthening exercises to a program of manual therapy and motor control exercises (standard therapy) in adults with chronic low back pain (cLBP). Researchers will compare individuals with cLBP that receive lumbar extensor strengthening in addition to standard therapy compared to standard therapy alone to determine if there are differences in patient reported outcomes, lumbar multifidus thickness, low back endurance, and healthcare utilization between the groups.
All participants will engage in 8-weeks of physical therapy, receiving manual therapy and motor control exercises. Those in the intervention group will have additional low back strengthening exercises.
Purpose:
The purpose of this study is to determine the effect of adding lumbar strengthening exercises to a program of manual therapy and motor control exercises in individuals with chronic low back pain.
Primary Aim:
Secondary Aims:
Study Design:
This will be a parallel randomized control trial with two arms. Participants will be randomly assigned to either the experiment (manual therapy, motor control, \& lumbar strengthening) or control (manual therapy \& motor control) group.
Procedures:
The following procedures will be conducted once the participant has signed and received their Informed Consent Document (ICD) and HIPAA Authorization. The initial baseline visit involves the participant completing the electronic questionnaires, lumbar multifidus assessment (via ultrasound), back endurance test, randomization, and an initial physical therapy evaluation.
INITIAL VISIT - BASELINE MEASURES \& START OF TREATMENT
Baseline Questionnaires:
Participants will be provided a tablet to complete research questionnaires electronically, described below, using REDCap. If a tablet or the internet is not available, participants will fill out a paper copy that the research team will later transfer on to REDCap. REDCap is a secure, HIPAA-compliant web application used to build, administer, and record surveys.
Baseline Ultrasound Measurement - Lumbar Multifidus Thickness: Once the surveys have been completed, study participants will have their lumbar multifidus thickness measured. The subject will lie prone with a pillow underneath their pelvis. Ultrasound images, using a curvilinear probe, of the lumbar multifidus muscle at rest will be captured. Three measurements of the muscles thickness will be captured, and the average on each side will be recorded at two vertebral segments (L4/L5 \& L5/S1). Images will be saved on a facility device for measurement.
Baseline Back Endurance Performance: After completing the ultrasound measurements, subjects will perform a back endurance test (Biering-Sørensen test) on the variable angle roman chair. Subjects will be positioned prone at a 0 degree angle with their iliac crests at the edge of the hip pads and their legs stabilized on the ankle pads. The time starts once their trunk is horizontal with their hands crossed at the chest. The test will continue until the participant breaks from the horizontal posture.
Randomization:
Following completion of the above procedures, participants will be randomized into one of the following groups: the standard physical therapy group (SPT) consisting of manual therapy \& motor control exercises, or the experimental group consisting of the standard physical therapy protocol plus lumbar extensor strengthening exercises (SPT+LEX). The method of group assignment will be sequentially numbered opaque sealed envelopes. To minimize the risk of predicting the treatment assignment of the next eligible subject, randomization will be performed in permuted blocks of 2 or 4 with random variation of the blocking number.
Both groups will begin standard physical therapy treatment on the same day as their baseline examination and will be scheduled for their subsequent appointments at the Physical Therapy clinic. The initial physical therapy evaluation will last approximately 60 minutes.
The treatment groups are outlined below:
Group 1- Standard Physical Therapy (SPT):
Participants randomized to the SPT group (control group) will receive pragmatic treatments of manual therapy and motor control exercises based on their clinical presentation, which is consistent with standard patient care management of chronic lower back pain. They will attend a total of 10-14 visits over a course of 8 weeks, as is typical for routine care of individuals with cLBP. The treating physical therapist will use manual therapy and motor control exercise interventions that will be tailored to the patient's individual presentation. Manual therapy is used by physical therapists to improve and restore movement patterns of the spine and extremities in individuals with LBP. Examples of manual therapy interventions include joint mobilization or manipulation, manual muscle stretching, and soft-tissue mobilization. Motor control exercises (MCE) are designed to restore the coordination and timing of trunk musculature.
Group 2- Standard Physical Therapy Plus Lumbar Extensor Strengthening (SPT+LEX):
Participants randomized to the SPT+LEX group (experimental group) will receive the same pragmatic treatments of manual therapy and MCE as the SPT group over the same number of visits (10-14). In addition to MCE and manual therapy, this group will perform specific lumbar extensor strengthening (LEX) exercises toward the end of each physical therapy treatment visit. These LEX exercises target the lumbar extensor muscle group (to include the lumbar multifidus) and may be performed by lying prone on the edge of a bench or mat and lifting the legs to parallel while the torso is stabilized. Alternatively, they may be performed by stabilizing the hips and legs while lifting the torso to varying angles from horizontal with or without weights. LEX exercises are progressed by increasing hold times or weight, depending on the participant's tolerance and clinical progression
Total time spent with the participant will be equal in both groups (40 minutes)
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Brooke Army Medical Center is the lead sponsor of 94 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Standard Physical Therapy
Other: Lumbar Extensor Strengthening plus Standard Physical Therapy
Participants randomized to the SPT group (control group) will receive pragmatic treatments of manual therapy and motor control exercises (MCE) based on their clinical presentation, which is consistent with standard patient care management of chronic lower back pain. They will attend a total of 10-14 visits over a course of 8 weeks, as is typical for routine care of individuals with cLBP. The treating physical therapist will use manual therapy and motor control exercise interventions that will be tailored to the patient's individual presentation.
Also known as: Manual Therapy, Motor Control Exercise
Participants randomized to the SPT+LEX group (experimental group) will receive the same pragmatic treatments of manual therapy and MCE as the control group over the same number of visits (10-14). In addition to MCE and manual therapy, this group will perform specific lumbar extensor strengthening. These exercises target the lumbar extensor muscle group (to include the lumbar multifidus) and may be performed by lying prone on the edge of a bench or mat and lifting the legs to parallel while the torso is stabilized. Alternatively, they may be performed by stabilizing the hips and legs while lifting the torso to varying angles from horizontal with or without weights.
Modified Oswestry Disability Index (mODI)
A 10-item disability questionnaire administered to evaluate the patient's symptoms and the functional impact of low back pain. Each item is scored on a 0-5 Likert scale. The total score is converted to a 0-100% disability index, with 0% indicating no functional limitation and 100% representing complete disability or a bedbound state.
Time frame: Enrollment, 4, 8, 12, and 26-weeks
PROMIS-29
A 29-item self-reported questionnaire that assesses seven key health domains; physical function, pain interference, fatigue, sleep disturbance, depression, anxiety, social participation, plus a single item for pain intensity. Ratings are on a 1-5 Likert scale. The PROMIS-29 is a core outcome measure in chronic LBP research.
Time frame: Enrollment, 4, 8, 12, and 26-weeks
Lumbar Spine Instability Questionnaire (LSIQ)
A 15-item self-reported questionnaire designed for patients with low back pain to assess perceived lumbar spinal instability. Items address symptom triggers, alleviating factors and movement-related behaviors. Higher scores reflect greater perceived instability.
Time frame: Enrollment
Patient Acceptable Symptom State (PASS)
A dichotomous questionnaire to determine if the participant believes their symptoms are acceptable
Time frame: Enrollment, 4, 8, 12, and 26-weeks
Healthcare Utilization
Participants will be queried on the healthcare resources they have used up to the time of taking this questionnaire. Items include other interventions, medication use, and specialty referrals
Time frame: Enrollment, 4, 8, 12, 26-weeks
Lumbar Multifidus Thickness: L4-L5, L5-S1 bilaterally
Resting Lumbar Multifidus (LM) Thickness is a physical measure of muscle thickness of the lumbar multifidus. Measured in one plane, it is a surrogate measure for overall hypertrophy of the muscle. Thickness of the LM is measured in millimeters from the most posterior aspect of the facet joint to the thoracolumbar fascia.
Time frame: Enrollment, 8, and 12-weeks
Back Endurance
The back endurance test (Biering-Sørensen test) will be conducted on a variable angle roman chair. Subjects will be positioned prone at a 0 degree angle with their iliac crests at the edge of the hip pads and their legs stabilized on the ankle pads. The time starts once their trunk is horizontal with their hands crossed at the chest. The test will continue until the participant breaks from the horizontal posture.
Time frame: Enrollment, 8, and 12-weeks
Plan to share: No
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