A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial

Conditions
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Low Back Pain, Manual Therapy, Education

Intervention / Treatment
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* Other: Manual Therapy with Traditional Biomechanical Explanation
* Other: Manual Therapy with Neuroplastiicity Explanation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Passive treatment<br>Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique. | Other: Manual Therapy with Traditional Biomechanical Explanation<br>* Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..<br>|
| Experimental: Active Treatment<br>Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique. | Other: Manual Therapy with Neuroplastiicity Explanation<br>* Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Back Pain Rating | Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0. LBP is reported to be 2.0. | Change from baseline to initial treatment | 
| Low Back Pain Rating | Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0. | Change from initial treatment to 2-4 days | 
| Lumbar flexion | Active trunk forward flexion in cm (distance finger tips to floor) | Change from baseline to initial treatment | 
| Lumbar flexion | Active trunk forward flexion in cm (distance finger tips to floor) | Change from initial treatment to 2-4 days | 
| Straight Leg Raise | Neurodynamic Measurement of Leg Raise (lower limb tension test) | Change from baseline to initial treatment | 
| Straight Leg Raise | Neurodynamic Measurement of Leg Raise (lower limb tension test) | Change from initial treatment to 2-4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Manual Therapy, Education, Neuroplasticiy