Effectiveness of Fascial Manipulation for Chronic Low Back Pain

Study Overview
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Brief Summary
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The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8 physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4 Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization and stretching exercises); whereas the second (control) will receive only the standard approach.

Detailed Description
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All patients were assessed and randomised by a physician. The control group intervention concerned of: relaxation of lumbar and respiration muscles, stretching for posterior muscular chain and hip flexors, assisted/active mobilization of lumbar region in sagittal plane and rotation, exercises to improve proprioception of lumbar spine, active and progressive movement of lumbar spine in anterior flexion, extension, lateroflexion and rotation, active exercise for lumbar stabilizers muscles, occupational training for activity of daily living, indications and recommendations for correct postures. The study group intervention received 4 manual intervention on deep fascial tissues, according to fascial manipulation tecnique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

Official Title
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Effectiveness of Fascial Manipulation for Chronic Low Back Pain. A Randomized Controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Fascial Manipulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a chronic low back pain (more than 7 weeks) age between 20 to 60 years old Exclusion Criteria: presence of neurological red flags continuative assumption of drugs for low back pain no positive imaging for spine lesions (fractures, spondilolistesi, vascular desease (aneurism abdominal aorta) secondary lesions (oncological desease) rheumatic systemic desease any other neurological desease which could compromise the partecipation to the program exercise

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: fascial manipolation<br>8 treatment sessions: 4 of fascial manipulation treatment, and 4 of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting) | Other: Fascial Manipulation<br>* 8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy<br>* Other names: manipulacion de la fascia;|
| Active Comparator: physiotherapy<br>8 treatment sessions of standard physiotherapy (rexing exercise, stretching, abdominal and paravertebral isometric muscular recruiting) | Other: Fascial Manipulation<br>* 8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy<br>* Other names: manipulacion de la fascia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disabilty level, evaluated with the Roland and Morris Disability Questionnaire | we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with at every fullow up (30 and 90 days from the end of the treatment) | from the first evaluation, at the end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain and social activity level evaluated with Brief Pain Inventory. | we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with at every fullow up (30 and 90 days from the end of the treatment) | from the first evaluation, at the end of the treatment | 
| quality of life, evaluated with SF-36 | we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with at every fullow up (30 and 90 days from the end of the treatment) | from the first evaluation, at the end of the treatment | 
| pain, assessed with visual analogical scale | we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with at every fullow up (30 and 90 days from the end of the treatment) | at the first evaluation, at the end of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, fascial manipulation, physioterapy, physical activity