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CompletedNCT03760887Updated Apr 23, 2019

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

An interventional study of Home exercise program only and Home exercise program and home program of sensory discrimination in Low Back Pain, sponsored by St. Ambrose University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by St. Ambrose University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Low Back Pain

Keywords

  • Low back pain
  • Sensory
  • Tactile
  • Education
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 102 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

St. Ambrose University is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
102 participants (actual)

Study arms

  • Sham comparator
    No Home Sensory training

    Patients who perform a home exercise program only

    Other: 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

Interventions

  • OtherHome 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

  • OtherHome 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.

06

What researchers measure

Primary outcomes

  1. Low Back Pain Rating

    Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)

    Time frame: Change from baseline to following treatment immediately upon completion of initial session

  2. Low Back Pain Rating

    Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)

    Time frame: Change from end of treatment initial session to 2-4 days

  3. Lumbar Flexion

    Active trunk forward flexion measured in cm (finger tips to floor)

    Time frame: Change from baseline to treatment immediately upon completion of initial session

  4. Lumbar Flexion

    Active trunk forward flexion measured in cm (finger tips to floor)

    Time frame: Change from end of treatment initial session to 2-4 days

  5. Straight Leg Raise

    Neurodynamic measurement of leg raise (lower limb tension test)

    Time frame: Change from baseline to treatment immediately upon completion of initial session

  6. Straight Leg Raise

    Neurodynamic measurement of leg raise (lower limb tension test)

    Time frame: Change from end of treatment initial session to 2-4 days

07

Study locations

1 site
  • St. Ambrose university
    Davenport, Iowa 52803, United States
08

References and documents

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)

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03760887
Lead sponsor
St. Ambrose University
Responsible party
Kevin Farrell (Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy, St. Ambrose University) — Principal investigator
First posted
Nov 30, 2018
Start date
Jun 1, 2018
Primary completion
Dec 30, 2018
Completion
Dec 30, 2018
Last update
Apr 23, 2019

Study contacts

Kevin Farrell
principal investigator · St. Ambrose University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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