A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain

Overview

To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.

Full Title of Study: “A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 30, 2018

Detailed Description

In a previous case series patients with chronic Low Back Pain (LBP) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. These changes, however, where only measured immediate post-intervention. This study aims to use a similar design of sensory discrimination for LBP, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. Changes will be assessed for pain and back and leg movement.

Interventions

  • Other: Home exercise program only
    • After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only
  • Other: Home exercise program and home program of sensory discrimination
    • After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.

Arms, Groups and Cohorts

  • Sham Comparator: No Home Sensory training
    • Patients who perform a home exercise program only
  • Experimental: Home sensory training
    • Patients who perform home exercise and home sensory training

Clinical Trial Outcome Measures

Primary Measures

  • Low Back Pain Rating
    • Time Frame: Change from baseline to following treatment immediately upon completion of initial session
    • Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
  • Low Back Pain Rating
    • Time Frame: Change from end of treatment initial session to 2-4 days
    • Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
  • Lumbar Flexion
    • Time Frame: Change from baseline to treatment immediately upon completion of initial session
    • Active trunk forward flexion measured in cm (finger tips to floor)
  • Lumbar Flexion
    • Time Frame: Change from end of treatment initial session to 2-4 days
    • Active trunk forward flexion measured in cm (finger tips to floor)
  • Straight Leg Raise
    • Time Frame: Change from baseline to treatment immediately upon completion of initial session
    • Neurodynamic measurement of leg raise (lower limb tension test)
  • Straight Leg Raise
    • Time Frame: Change from end of treatment initial session to 2-4 days
    • Neurodynamic measurement of leg raise (lower limb tension test)

Participating in This Clinical Trial

Inclusion Criteria

  • adults over the age of 18 – patients presenting at PT with a primary complaint of LBP – LBP being present for 3 months or more – fluent in English – willing to participate in the study – They also will need someone who can assist with a sensory discrimination HEP. Exclusion Criteria:

  • under age 18 – not able to read/understand the English language – prisoners – no medical issues precluding physical therapy treatment (red flags) – if they had undergone spinal surgery – if they had any skin or medical condition preventing them from receiving tactile stimuli on the lower back or had specific movement-based precautions, i.e., no active spinal flexion. – Patients presenting with leg pain only – Patients with neurological deficit only in the lower extremity

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Ambrose University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kevin Farrell, Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy – St. Ambrose University
  • Overall Official(s)
    • Kevin Farrell, Principal Investigator, St. Ambrose University

References

Louw A, Farrell K, Wettach L, Uhl J, Majkowski K, Welding M (2015) Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy 43(2)

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