Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain

Study Overview
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Brief Summary
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Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.

Official Title
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Manual Therapy Followed by Specific Active Exercises Versus a Placebo Followed by Specific Active Exercises on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain: a Randomized Controlled Trial

Conditions
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Back Pain Lower Back Chronic

Intervention / Treatment
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* Procedure: Manual therapy and active exercises
* Procedure: Detuned ultrasound and active exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks can maintain the usual medication Exclusion Criteria: spinal fracture or surgery within the previous 6 months pregnancy neoplasia spinal infection spinal inflammatory arthritis low back pain of visceral origin severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months score of 3/5 or more on the Waddell Score on sick leaves from work for 6 months or more psychiatric disorders opioid medication patient unable to collaborate (linguistic barrier; cognitive impairments) radiologic abnormalities other than degenerative disease clinical neurogenic claudication.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual therapy and active exercises<br>Spinal manipulation /mobilisation | Procedure: Manual therapy and active exercises<br>* Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust. Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises<br>* Other names: Manipulation;|
| Placebo Comparator: Detuned ultrasound and active exercises<br> | Procedure: Detuned ultrasound and active exercises<br>* Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises<br>* Other names: Electrotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale - VAS-pain | self-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements no pain on the left and maximum intensity of pain on the right | During treatment, over a period of 4 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ) | measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain | Before randomization and untill 6 months after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic non specific low back pain, Manual therapy, Active exercises, Pain, Disability