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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06554236
Enrollment
48
Registered
2024-08-15
Start date
2024-08-31
Completion date
2025-06-30
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

two-point discrimination, physical therapy, somatoperception, tactile acuity

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.

Interventions

OTHERphysical therapy and sensory training

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

Sponsors

Brooke Army Medical Center
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

quasi-experimental, one-group repeated measures design

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tactile acuity as measured by two-point discrimationPerformed 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

MeasureTime frameDescription
Pain as measured by numeric pain rating scalePerformed 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)
Low back perceptionPerformed 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
Tactile Localization AccuracyPerformed 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
FunctionPerformed 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

Contacts

Primary ContactBrooke Barletta, DPT
brooke.a.barletta.mil@health.mil808-391-6929

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026