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

October 11, 2019 updated by: Manuel Rebollo Salas, University of Seville

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Sevilla, Spain, 41009
        • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
Subjects will receive 4 massotherapy sessions and 4 of HYPOPRESSIVE ABDOMINAL GYMNASTIC (HAG).
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.
Experimental: GROUP RECEIVING MASSOTHERAPY
The subjects of this group will receive a total of 8 sessions of 30 minutes each.

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.

Experimental: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC
The subjects of this group will receive a total of 8 sessions of 30 minutes each.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Self-reported lumbar pain intensity at 3 weeks.
Time Frame: At the start of the study, before the fifth treatment session (third week)
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.
Time Frame: After the last treatment session (fifth week).
Measured by the Oswestry disability index.
After the last treatment session (fifth week).
Change from Disability at 3 weeks.
Time Frame: At the start of the study, before the fifth treatment session (third week)
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.
Time Frame: After the last treatment session (fifth week).
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.
Time Frame: At the start of the study, before the fifth treatment session (third week)
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.
Time Frame: After the last treatment session (fifth week).
Lumbar flexion measured by the modified Schober test
After the last treatment session (fifth week).
Change from Quality of life at 3 weeks.
Time Frame: At the start of the study, before the fifth treatment session (third week)
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.
Time Frame: After the last treatment session (fifth week).
Measured by the Short-Form-12 Health Survey
After the last treatment session (fifth week).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USeville-MSalas

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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