The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain
- Conditions
- Low Back Pain
- Registration Number
- NCT06554236
- Lead Sponsor
- Brooke Army Medical Center
- Brief Summary
Individuals with chronic low back pain and other chronic pain conditions have been shown to have altered somatosensory, the ability to sense input to the tissue, which is processed in the primary somatosensory cortex or S1. Two-point discrimination is currently the best clinical tool utilized to assess an individual's ability to sense touch. This study will assess TPD changes after a course of standard physical therapy care with the addition of sensory training.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
- DEERS eligible
- 18 to 64 years old
- Low back pain > 3 months
- Numeric Pain Rating Scale minimal pain rating of 3/10 in the last seven days
- Must be able to commit to 6-10 treatment sessions over a period of at least 6-we
- History of spinal surgery
- History of spinal injections or nerve ablations in the past year
- History of traumatic brain injury (TBI)
- History of cerebral vascular accident (CVA)
- Currently pregnant
- Active cancer
- Symptoms below the knee
- Non-MSK condition contributing to low back pain
- Chronic Pain Conditions to include Chronic Regional Pain Syndrome and Fibromyalgia
- Autoimmune Diseases (to include Ankylosing Spondylitis, Lupus, Rheumatoid Arthritis)
- Currently under litigation related to low back pain
- Currently going through Medical Evaluation Board (MEB)
- Retiring or separating from the military within a year
- Currently receiving physical therapy for low back pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tactile acuity as measured by two-point discrimation Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks). measured using a Caroline 2-point discriminator tool. TPD is the most widely accepted objective measurement of tactile acuity in the clinical setting
- Secondary Outcome Measures
Name Time Method Function Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks). measured by the Oswestry Disability Index (ODI), 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability
Pain as measured by numeric pain rating scale Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks). The NPRS is an 11-point numerical pain rating scale used to measure pain. Patients rate pain ranging between 0 (no pain) and 10 (worst pain imaginable)
Tactile Localization Accuracy Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks). measured by the number of correct responses out of 9 attempts for stimulation of the 9-grid chart
Low back perception Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks). measured using the Freemont Back Awareness Questionnaire (FreBAQ), a multi-item, self-report questionnaire designed to quantify distorted perception of the back in people with CLBP