Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain

Study Overview
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Brief Summary
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Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP). The aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.

Detailed Description
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A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.

Official Title
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Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.

Conditions
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Central Sensitization, Manual Therapy

Intervention / Treatment
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* Other: manual therapy
* Other: conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-spesific low back pain patients with pain longer than 12 weeks aged between 20-64 years male and female participants Exclusion Criteria: concomitant disease that would interfere with treatment pregnancy have had any spinal surgery or fracture

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 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
Interventional Model Description: prospective randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual therapy<br>Manual therapy group | Other: manual therapy<br>* The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.<br>* Other names: conventional physiotherapy;Other: conventional physiotherapy<br>* Control group will only receive conventionel physiotherapy intervention.<br>|
| Other: Conventional physiotherapy<br>Conventional physiotherapy group | Other: manual therapy<br>* The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.<br>* Other names: conventional physiotherapy;Other: conventional physiotherapy<br>* Control group will only receive conventionel physiotherapy intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | A 10 cm Visual Analog Scale will be used to determine the severity of pain, with numbers ranging from 0 (no pain) to 10 (unbearable pain) | Up to one month | 
| Central Sensitization | Central Sensitization Inventory (CSI) scale will be used severity of central sensitization.The total score range of the scale, which consists of a total of 25 questions, is between 0-100 points. Central sensitization with a score of 40 and above is considered positive. An increase in the total score indicates an increase in the level of central sensitization. | Up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Oswestry Disability Index (ODI) will be used to measure disability level | Up to one month | 
| Health Survey | 36-item Short Form Health Survey Questionnaire (SF-36) will be used | Up to one month | 
| Hospital Anxeity and depresssion | Hospital Anxeity and Depression Scale will be used. The cut-off points for caseness of anxiety or depression is 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83. The scores of the scale are as follows: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) | Up to one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central sensitization, manual therapy, non-specific low back pain