Myofascial Massage in the Treatment of Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effectiveness of an approach that combines massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the words of the physiotherapist compared to a traditional massage therapy in reducing pain in patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is linked to the interoceptive awareness and which is the patient's ability to relax through the measurement of the hearth rate variability (HRV).

Official Title
-----------------
The Myofascial Massage in the Treatment of Chronic Non-specific Low Back Pain: the Experience of Contact

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Other: Massage therapy
* Other: Neurocognitive rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of chronic nonspecific low back pain for at least three months Subjects aged between 18 and 50 years Exclusion Criteria: Presence of acute low back pain Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis) Disorders of central and/or peripheral nervous system Systemic inflammatory disease (eg rheumatoid arthritis) Systemic infectious disease Neoplastic disease Previous Surgery Cognitive impairment Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Massage therapy and contact experience<br>Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading associated with a preparation to the contact phase of the massage using the typical elements of neurocognitive rehabilitation such as motor imagery, dynamic state during which a person mentally simulates an action, and language, necessary to understand the way of perceiving and organizing sensory, cognitive and phenomenological informations by the patients and so to interpretate pain in a more articulate way. | Other: Massage therapy<br>* Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.<br>Other: Neurocognitive rehabilitation<br>* Provided through the association of motor imagery and the words of the physiotherapist with the aim of increasing the effectiveness of massage in reducing pain.<br>|
| Active Comparator: Massage therapy<br>Traditional massage therapy consisting of different phases: surface touch, deep touch, static pressures, dynamic pressures and kneading. | Other: Massage therapy<br>* Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Visual Analogue Scale (VAS) from baseline to 12 weeks | It is a scale for the assessment of pain and it's based on a ten point scale, where 0 means no pain and 10 the greatest pain ever both at rest and during movements. | baseline, 4 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of McGill Pain Questionnaire from baseline to 12 weeks | This scales evaluates the degree of functional impairment in activities of daily life caused by pain. It consist of ten sections including pain intensity, personal care, lifting, walking, sitting standing, sleeping, sex, social life and travelling. Each section includes six sentences relating to different level of limitation in the same activity (0: no limitation, 5: maximal limitation). | baseline, 4 weeks, 12 weeks | 
| Change of Multidimensional Assessment of Interoceptive Awareness (MAIA) from baseline to 12 weeks | The questionnaire is divided into 32 items organized into eight subcategories consisting of three to seven items each. The subcategories measure: the awareness of unpleasant, pleasant or neutral body sensations, the tendency not to ignore the feelings of pain or discomfort, not to worry about painful sensations or discomfort, the ability not to draw attention away from body sensations, awareness of the existence of connections between body sensations and emotional status, the ability to control the psychological stress by focusing on body sensations, the ability to listen to your body and the belief that the experiences coming from your body are safe and reliable. It 'a multidimensional assessment questionnaire and self-administered. For each subcategory, the patient may express a score from 0 (never) to 5 (always), the highest score corresponds to a higher level of awareness. | baseline, 4 weeks, 12 weeks | 
| Change of SF-12 Health Survey Questionnaire from baseline to 12 weeks | The questionnaire consist in twelve questions that explore eight sub-categories that measure the physical activity, role limitations due to physical health and emotional state, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM). | baseline, 4 weeks, 12 weeks | 
| Change of Waddell Disability Index from baseline to 12 weeks | It includes nine parameters: pain experienced in a sitting position, travelling, standing,walking and lifting weights and the need to put on or remove footwear, sleep disturbance, life restriction and sex life restriction to measure. The maximum score is 9 points. A score > 5 indicates significant disability. | baseline, 4 weeks, 12 weeks | 
| Change of hearth rate variability (HRV) expressed as coherent ratio from baseline to 4 weeks | Its an index monitored by a plethysmograph that records the heart rate variability (variation in the time interval between a heartbeat and the other) a parameter capable of expressing a person's level of stress through the coherence ratio. | baseline, 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back pain, interoceptive awareness, motor imagery, massage