The Effectiveness of the Massage and the Hypopressive Abdominal Gymnastics on Low Back Pain (MAS-GAH)

Study Overview
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Brief Summary
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The main goal of this study is to get to know if applying both, massotherapy plus hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low back pain. It actually reduces the inability produced by the pain and improve the patient's quality of life as well as the join range of the lumbar spine, way more than these two therapies applied separately.

Detailed Description
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Background: Back pain is one of the most common musculoskeletal disorders in the industrialized society. It is estimated to affect between 70 to 85% of the adult population over their live. The impact of low back pain is widespread in developed countries, and accounts the major spending in economic and health resources, as well as being associated with the leading causes of absenteeism and disability. Diagnosis, in most cases, nonspecific low back pain, the symptoms have no clear cause, so that the source of pain is unknown. In general, a significant percentage progresses to chronic back pain and is accompanied by a limitation of physical activity influenced by improper posture or movement patterns. Objectives: To assess the effectiveness of massage therapy and hypopressive abdominal gymnastics, and the combination of both therapeutic modalities, to decrease pain and lumbar disability; and increasing joint mobility and quality of life in patients with chronic nonspecific low back pain.

Official Title
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The Effects of Massage Therapy and Hypopressive Abdominal Exercises on Chronic Non-specific Low Back Pain, Joint Mobility, Disability and the Patient's Quality of Life. A Controlled Clinical Trial

Conditions
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Low-back Pain

Intervention / Treatment
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* Procedure: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
* Procedure: GROUP RECEIVING MASSOTHERAPY
* Procedure: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic non-specific low back pain diagnosed and at least 12 weeks of mechanical pain. Exclusion Criteria: Patients: With arterial hypertension diagnosed. With progressive neurological deficits. Pregnant or suspect that they are pregnant. With psychological or psychiatric process diagnosed. Under analgesic treatment.

Ages Eligible for Study
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Minimum Age: 20 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: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC<br>Subjects will receive 4 massotherapy sessions and 4 of HYPOPRESSIVE ABDOMINAL GYMNASTIC (HAG). | Procedure: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC<br>* The subjects of this group will receive an amount of eight sessions that will be applied within five weeks; four massotherapy sessions and another 4 of H.A.G. The three first weeks one session of each methodology will be applied, starting always with massotherapy (with sessions on Mondays and Thursdays or on Tuesdays and Fridays). On the fourth week a session of massotherapy will be applied on the same day as usual. And, finally, on the fifth week a session of H.A.G will be applied on the same day as massotherapy is applied.<br>|
| Experimental: GROUP RECEIVING MASSOTHERAPY<br>The subjects of this group will receive a total of 8 sessions of 30 minutes each. | Procedure: GROUP RECEIVING MASSOTHERAPY<br>* The sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before. Massotherapy technics will be applied all over the back, covering the thoracolumbar area as well as upper areas reaching the cervix and occiput. In particular, posterosuperior iliac spines, iliac crests, ribs, shoulder girdle and the entire spine (sacral bone- lumbar area-backbones-cervical vertebrae) and its attached tissues will be worked down. Massotherapy protocol will be applied by the physical therapist, always respecting the postural ergonomics. This enables the verticality of the body (avoiding the slopes) which makes work much easier thanks to the inertia triggered by the load transfer in the lower extremities in both sagittal and horizontal plane.<br>|
| Experimental: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC<br>The subjects of this group will receive a total of 8 sessions of 30 minutes each. | Procedure: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC<br>* The subjects of this group will receive a total of 8 sessions of 30 minutes each; sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before. The techniques applied are an assembly of rhythm, postural and breathing exercises that have to be done in a systematically. The physical therapist will check that all of the group subjects have assimilated properly the H.A.G and the breathing patterns from the exercises protocol. If they have, then the practical session which comprises 6 hypopressive exercises, can be started. The subjects must remain in each position between 10 and 30 seconds and repeat the exercise three times, with a rest period among each that will last at least 20 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Self-reported lumbar pain intensity at 3 weeks. | Evaluated by the numerical pain scale. | At the start of the study, before the fifth treatment session (third week) | 
| Change from Self-reported lumbar pain intensity at 5 weeks. | Measured by the Oswestry disability index. | After the last treatment session (fifth week). | 
| Change from Disability at 3 weeks. | Measured by the Oswestry disability index. | At the start of the study, before the fifth treatment session (third week) | 
| Change from Disability at 5 weeks. | Measured by the Oswestry disability index. | After the last treatment session (fifth week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Lumbar joint mobility at 3 weeks. | Lumbar flexion measured by the modified Schober test | At the start of the study, before the fifth treatment session (third week) | 
| Change from Lumbar joint mobility at 5 weeks. | Lumbar flexion measured by the modified Schober test | After the last treatment session (fifth week). | 
| Change from Quality of life at 3 weeks. | Measured by the Short-Form-12 Health Survey | At the start of the study, before the fifth treatment session (third week) | 
| Change from Quality of life at 5 weeks. | Measured by the Short-Form-12 Health Survey | After the last treatment session (fifth week). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-back pain, massage therapy, Gymnastics, disability