Back to resultsA Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home exercise program only
Home exercise program and home program of sensory discrimination
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Sensory, Tactile, Education
Eligibility 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
Sites / Locations
- St. Ambrose university
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
No Home Sensory training
Home sensory training
Arm Description
Patients who perform a home exercise program only
Patients who perform home exercise and home sensory training
Outcomes
Primary Outcome Measures
Low Back Pain Rating
Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
Low Back Pain Rating
Numeric Pain Rating Scale for Back pain (0 = no pain and 10 = worst pain)
Lumbar Flexion
Active trunk forward flexion measured in cm (finger tips to floor)
Lumbar Flexion
Active trunk forward flexion measured in cm (finger tips to floor)
Straight Leg Raise
Neurodynamic measurement of leg raise (lower limb tension test)
Straight Leg Raise
Neurodynamic measurement of leg raise (lower limb tension test)
Secondary Outcome Measures
Full Information
NCT ID
NCT03760887
First Posted
November 26, 2018
Last Updated
April 22, 2019
Sponsor
St. Ambrose University
1. Study Identification
Unique Protocol Identification Number
NCT03760887
Brief Title
A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain
Official Title
A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Ambrose University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Sensory, Tactile, Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Participant
Masking Description
Patients were randomly assigned to one of two groups (control or experimental).
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Home Sensory training
Arm Type
Sham Comparator
Arm Description
Patients who perform a home exercise program only
Arm Title
Home sensory training
Arm Type
Experimental
Arm Description
Patients who perform home exercise and home sensory training
Intervention Type
Other
Intervention Name(s)
Home exercise program only
Intervention Description
After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only
Intervention Type
Other
Intervention Name(s)
Home exercise program and home program of sensory discrimination
Intervention Description
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 Measure Information:
Title
Low Back Pain Rating
Description
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
Title
Low Back Pain Rating
Description
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
Title
Lumbar Flexion
Description
Active trunk forward flexion measured in cm (finger tips to floor)
Time Frame
Change from baseline to treatment immediately upon completion of initial session
Title
Lumbar Flexion
Description
Active trunk forward flexion measured in cm (finger tips to floor)
Time Frame
Change from end of treatment initial session to 2-4 days
Title
Straight Leg Raise
Description
Neurodynamic measurement of leg raise (lower limb tension test)
Time Frame
Change from baseline to treatment immediately upon completion of initial session
Title
Straight Leg Raise
Description
Neurodynamic measurement of leg raise (lower limb tension test)
Time Frame
Change from end of treatment initial session to 2-4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Farrell
Organizational Affiliation
St. Ambrose University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Ambrose university
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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)
Results Reference
background
Learn more about this trial
A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain
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