The Influence of an Orthopaedic Manual Physical Therapy and Sensory Training on Somatoperception in Patients with Chronic Low Back Pain

N/ANot Yet RecruitingNCT06554236

Brooke Army Medical Center48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Low Back Pain

Interventions

physical therapy and sensory trainingOTHER

Physical therapy standard of care and 5 minutes of sensory training.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Tactile acuity as measured by two-point discrimation

measured using a Caroline 2-point discriminator tool. TPD is the most widely accepted objective measurement of tactile acuity in the clinical setting

Time frame: Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).

Secondary Outcomes

Pain as measured by numeric pain rating scale

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)

Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

Low back perception

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

Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

Tactile Localization Accuracy

measured by the number of correct responses out of 9 attempts for stimulation of the 9-grid chart

Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

Function

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

Time frame: Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).

Central Contacts

Brooke Barletta, DPT

CONTACT

808-391-6929 brooke.a.barletta.mil@health.mil

Data from ClinicalTrials.gov

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