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

ConditionLow Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBrooke Army Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • physical therapy and sensory training

    Other intervention

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

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Chronic low back painExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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).
2

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).
3

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).
4

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).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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