Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

Study Overview
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Brief Summary
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This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.

Detailed Description
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Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided. Outcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.

Official Title
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The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain

Conditions
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Low Back Pain, Mechanical Low Back Pain, Backache

Intervention / Treatment
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* Other: Thrust Manipulation
* Other: Non-thrust manipulation (NTM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Chronic Low back pain (pain lasting for at least 12 weeks) NPRS ≥ 3 Exclusion Criteria: Previous surgery or fracture at the lumbar spine Pregnancy Inflammatory disorders Symptoms distal to the gluteal line Having received manipulative treatment in the past four weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrust manipulation (TM)<br>The patients allocated to the TM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive a rotational TM technique. The treating therapist will have up to two attempts to perform the TM in each patient. There is no need for cavitation in order to consider the TM successful; the occurence of cavitation, however, will be recorded. A single treatment will be provided. | Other: Thrust Manipulation<br>* After positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM.<br>* Other names: Manipulative therapy;|
| Experimental: Non-thrust manipulation (NTM)<br>The patients allocated to the NTM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive 30 oscilations of a grade III rotational NTM. A single treatment will be provided | Other: Non-thrust manipulation (NTM)<br>* A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.<br>* Other names: Maitland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS) | Up to 10 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Perceived Effect | Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE) | Up to 10 minutes after intervention | 
| Lumbar joint position sense | Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY) | Up to 10 minutes after intervention | 
| Peak plantar pressure | Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro) | Up to 10 minutes after intervention | 
| Center of Pressure displacement | CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry | Up to 10 minutes after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Thrust manipulation, Spinal manipulation, Joint mobilization, Non-thrust manipulation, proprioception, Postural stability, Baropodometry