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

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ClinicalTrials.gov Identifier: NCT03760887
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin Farrell, St. Ambrose University

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Home exercise program only Other: Home exercise program and home program of sensory discrimination Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Control Trial
Masking: Single (Participant)
Masking Description: Patients were randomly assigned to one of two groups (control or experimental).
Primary Purpose: Treatment
Official Title: A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760887


Locations
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United States, Iowa
St. Ambrose university
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
St. Ambrose University
Investigators
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Principal Investigator: Kevin Farrell St. Ambrose University

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)

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Responsible Party: Kevin Farrell, Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy, St. Ambrose University
ClinicalTrials.gov Identifier: NCT03760887     History of Changes
Other Study ID Numbers: StAmbroseU sensory
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin Farrell, St. Ambrose University:
Low back pain
Sensory
Tactile
Education
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms