Thrust Manipulation Versus Non-Thrust Manipulation

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.

Detailed Description
-----------------
Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.

Official Title
-----------------
Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial

Conditions
-----------------
Mechanical Low Back Pain

Intervention / Treatment
-----------------
* Procedure: Thrust manipulation
* Procedure: Non-thrust manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study. For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments. Exclusion Criteria: The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.) Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45° Muscle weakness involving a major muscle group of the lower extremity, Diminished lower extremity muscle stretch reflex Diminished or absent sensation to pinprick in any lower extremity dermatome) Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrust manipulation<br>Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals | Procedure: Thrust manipulation<br>* Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region<br>* Other names: Manipualtion (Manip);|
| Active Comparator: Non-thrust manipulation<br>Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals | Procedure: Non-thrust manipulation<br>* Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback<br>* Other names: Mobilization (Mob);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index | Change score | Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | Change score | Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
manipulation, mobilization, low back pain, treatment