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

A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Home exercise program only; Other: Home exercise program and home program of sensory discrimination

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • St. Ambrose University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: No Home Sensory training; Patients who perform a home exercise program only	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
EXPERIMENTAL: Home sensory training; Patients who perform home exercise and home sensory training	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St. Ambrose University

Publications and helpful links

General Publications

• 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)

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (ACTUAL): November 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 22, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Low back pain; Education; Sensory; Tactile
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: StAmbroseU sensory

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No