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

Primary Purpose

Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
GROUP RECEIVING MASSOTHERAPY
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low-back Pain focused on measuring low-back pain, massage therapy, Gymnastics, disability

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC

GROUP RECEIVING MASSOTHERAPY

GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC

Arm Description

Subjects will receive 4 massotherapy sessions and 4 of HYPOPRESSIVE ABDOMINAL GYMNASTIC (HAG).

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.

Outcomes

Primary Outcome Measures

Change from Self-reported lumbar pain intensity at 3 weeks.
Evaluated by the numerical pain scale.
Change from Self-reported lumbar pain intensity at 5 weeks.
Measured by the Oswestry disability index.
Change from Disability at 3 weeks.
Measured by the Oswestry disability index.
Change from Disability at 5 weeks.
Measured by the Oswestry disability index.

Secondary Outcome Measures

Change from Lumbar joint mobility at 3 weeks.
Lumbar flexion measured by the modified Schober test
Change from Lumbar joint mobility at 5 weeks.
Lumbar flexion measured by the modified Schober test
Change from Quality of life at 3 weeks.
Measured by the Short-Form-12 Health Survey
Change from Quality of life at 5 weeks.
Measured by the Short-Form-12 Health Survey

Full Information

First Posted
March 18, 2016
Last Updated
October 11, 2019
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT02721914
Brief Title
The Effectiveness of the Massage and the Hypopressive Abdominal Gymnastics on Low Back Pain (MAS-GAH)
Acronym
MAS-GAH
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-back Pain
Keywords
low-back pain, massage therapy, Gymnastics, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
Arm Type
Experimental
Arm Description
Subjects will receive 4 massotherapy sessions and 4 of HYPOPRESSIVE ABDOMINAL GYMNASTIC (HAG).
Arm Title
GROUP RECEIVING MASSOTHERAPY
Arm Type
Experimental
Arm Description
The subjects of this group will receive a total of 8 sessions of 30 minutes each.
Arm Title
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC
Arm Type
Experimental
Arm Description
The subjects of this group will receive a total of 8 sessions of 30 minutes each.
Intervention Type
Procedure
Intervention Name(s)
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
GROUP RECEIVING MASSOTHERAPY
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Self-reported lumbar pain intensity at 3 weeks.
Description
Evaluated by the numerical pain scale.
Time Frame
At the start of the study, before the fifth treatment session (third week)
Title
Change from Self-reported lumbar pain intensity at 5 weeks.
Description
Measured by the Oswestry disability index.
Time Frame
After the last treatment session (fifth week).
Title
Change from Disability at 3 weeks.
Description
Measured by the Oswestry disability index.
Time Frame
At the start of the study, before the fifth treatment session (third week)
Title
Change from Disability at 5 weeks.
Description
Measured by the Oswestry disability index.
Time Frame
After the last treatment session (fifth week).
Secondary Outcome Measure Information:
Title
Change from Lumbar joint mobility at 3 weeks.
Description
Lumbar flexion measured by the modified Schober test
Time Frame
At the start of the study, before the fifth treatment session (third week)
Title
Change from Lumbar joint mobility at 5 weeks.
Description
Lumbar flexion measured by the modified Schober test
Time Frame
After the last treatment session (fifth week).
Title
Change from Quality of life at 3 weeks.
Description
Measured by the Short-Form-12 Health Survey
Time Frame
At the start of the study, before the fifth treatment session (third week)
Title
Change from Quality of life at 5 weeks.
Description
Measured by the Short-Form-12 Health Survey
Time Frame
After the last treatment session (fifth week).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25474502
Citation
Trampas A, Mpeneka A, Malliou V, Godolias G, Vlachakis P. Immediate Effects of Core-Stability Exercises and Clinical Massage on Dynamic-Balance Performance of Patients With Chronic Specific Low Back Pain. J Sport Rehabil. 2015 Nov;24(4):373-83. Epub 2014 Dec 4.
Results Reference
background
PubMed Identifier
26441380
Citation
Resende AP, Torelli L, Zanetti MR, Petricelli CD, Jarmy-Di Bella ZI, Nakamura MU, Araujo Junior E, Moron AF, Girao MJ, Sartori MG. Can Abdominal Hypopressive Technique Change Levator Hiatus Area?: A 3-Dimensional Ultrasound Study. Ultrasound Q. 2016 Jun;32(2):175-9. doi: 10.1097/RUQ.0000000000000181.
Results Reference
result
PubMed Identifier
21826719
Citation
Stupp L, Resende AP, Petricelli CD, Nakamura MU, Alexandre SM, Zanetti MR. Pelvic floor muscle and transversus abdominis activation in abdominal hypopressive technique through surface electromyography. Neurourol Urodyn. 2011 Nov;30(8):1518-21. doi: 10.1002/nau.21151. Epub 2011 Aug 8.
Results Reference
result
PubMed Identifier
26985522
Citation
Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt E. Noninvasive Treatments for Low Back Pain [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Feb. Report No.: 16-EHC004-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK350276/
Results Reference
result
PubMed Identifier
26767971
Citation
Sejari N, Kamaruddin K, Ramasamy K, Lim SM, Neoh CF, Ming LC. The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patients with low back pain: study protocol of a randomised controlled trial. BMC Complement Altern Med. 2016 Jan 15;16:16. doi: 10.1186/s12906-016-0988-1.
Results Reference
result
PubMed Identifier
26329399
Citation
Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
Results Reference
result
PubMed Identifier
33587856
Citation
Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Lorenzo-Munoz A, Pinero-Pinto E, Rebollo-Salas M. Clinical relevance of massage therapy and abdominal hypopressive gymnastics on chronic nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2022 Aug;44(16):4233-4240. doi: 10.1080/09638288.2021.1884903. Epub 2021 Feb 15.
Results Reference
derived
PubMed Identifier
29681973
Citation
Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Gomez-Benitez MA, De-La-Casa-Almeida M, Rebollo-Salas M. Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Feb 22;2018:3684194. doi: 10.1155/2018/3684194. eCollection 2018. Erratum In: Evid Based Complement Alternat Med. 2018 Sep 6;2018:3601984.
Results Reference
derived

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

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