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Clinical Trials/NCT06554236
NCT06554236
Not yet recruiting
Not Applicable

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

Brooke Army Medical Center0 sites48 target enrollmentAugust 31, 2024
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Brooke Army Medical Center
Enrollment
48
Primary Endpoint
Tactile acuity as measured by two-point discrimation
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2024
End Date
June 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brooke Barletta

Principal Investigator

Brooke Army Medical Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Tactile acuity as measured by two-point discrimation

Time Frame: 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 Outcomes

  • Function(Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).)
  • Pain as measured by numeric pain rating scale(Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).)
  • Tactile Localization Accuracy(Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).)
  • Low back perception(Performed at baseline, 4th week of treatment, and final visit (8 +/- 2 weeks).)

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