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

August 13, 2024 updated by: Brooke Barletta, Brooke Army Medical Center

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

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Performed at baseline visit, 4th week of treatment, and at final visit (8 +/- 2 weeks).

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2024.071d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Requests for deidentified data will be considered on a case by case basis.

IPD Sharing Time Frame

Requests for deidentified data will be considered on a case by case basis.

IPD Sharing Access Criteria

Requests for deidentified data will be considered on a case by case basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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