Clinical trial NCT03760887: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Sensory
Tactile
Education
Lead sponsor: St. Ambrose University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Low Back Pain Rating
timeFrame: Change from baseline to following treatment immediately upon completion of initial session
measure: Low Back Pain Rating
timeFrame: Change from end of treatment initial session to 2-4 days
measure: Lumbar Flexion
timeFrame: Change from baseline to treatment immediately upon completion of initial session
measure: Lumbar Flexion
timeFrame: Change from end of treatment initial session to 2-4 days
measure: Straight Leg Raise
timeFrame: Change from baseline to treatment immediately upon completion of initial session
measure: Straight Leg Raise
timeFrame: Change from end of treatment initial session to 2-4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Davenport
country: United States
facility: St. Ambrose university
state: Iowa
Study officials:
affiliation: St. Ambrose University
name: Kevin Farrell
role: PRINCIPAL_INVESTIGATOR
References:
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)