Clinical trial NCT03758807: A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain
Official title: A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Manual Therapy
Education
Keywords: Low back pain
Manual Therapy
Education
Neuroplasticiy
Lead sponsor: St. Ambrose University
Sponsor class: OTHER
First posted: 2018-11-29
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 between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

Detailed description: Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or 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 6 months or more
* fluent in English
* willing to participate in the study.

Exclusion Criteria:

* under age 18
* not able to read/understand the English language
* prisoners
* no medical issues precluding physical therapy treatment (red flags)
* no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
* prior spine surgery
* unable to lay prone for the treatment

Primary outcomes:
measure: Low Back Pain Rating
timeFrame: Change from baseline to initial treatment
measure: Low Back Pain Rating
timeFrame: Change from initial treatment to 2-4 days
measure: Lumbar flexion
timeFrame: Change from baseline to initial treatment
measure: Lumbar flexion
timeFrame: Change from initial treatment to 2-4 days
measure: Straight Leg Raise
timeFrame: Change from baseline to initial treatment
measure: Straight Leg Raise
timeFrame: Change from initial treatment to 2-4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Kevin Farrell
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, Wedling M. Immediate effects of sensory discrimination for chronic low back pain: a case series. New Zealand Journal of Physiotherapy. 2015;43(2):58-63.
citation: Louw A, Farrell K, Landers M, Barclay M, Goodman E, Gillund J, McCaffrey S, Timmerman L. The effect of manual therapy and neuroplasticity education on chronic low back pain: a randomized clinical trial. J Man Manip Ther. 2017 Dec;25(5):227-234. doi: 10.1080/10669817.2016.1231860. Epub 2016 Sep 22.