NCT02721914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

March 18, 2016

Last Update Submit

October 11, 2019

Conditions

Keywords

low-back painmassage therapyGymnasticsdisability

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Change from Lumbar joint mobility at 3 weeks.

    At the start of the study, before the fifth treatment session (third week)

  • Change from Lumbar joint mobility at 5 weeks.

    After the last treatment session (fifth week).

  • Change from Quality of life at 3 weeks.

    At the start of the study, before the fifth treatment session (third week)

  • Change from Quality of life at 5 weeks.

    After the last treatment session (fifth week).

Study Arms (3)

GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC

EXPERIMENTAL

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

Procedure: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC

GROUP RECEIVING MASSOTHERAPY

EXPERIMENTAL

The subjects of this group will receive a total of 8 sessions of 30 minutes each.

Procedure: GROUP RECEIVING MASSOTHERAPY

GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC

EXPERIMENTAL

The subjects of this group will receive a total of 8 sessions of 30 minutes each.

Procedure: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC

Interventions

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.

GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC

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.

GROUP RECEIVING MASSOTHERAPY

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.

GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic non-specific low back pain diagnosed and at least 12 weeks of mechanical pain.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seville, 41009, Spain

Location

Related Publications (8)

  • 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. doi: 10.1123/jsr.2014-0215. Epub 2014 Dec 4.

    PMID: 25474502BACKGROUND
  • 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.

  • 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.

  • 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/

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 29, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2018

Last Updated

October 15, 2019

Record last verified: 2019-01

Locations