Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02721914
Other study ID # USeville-MSalas
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date July 2018

Study information

Verified date January 2019
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2018
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
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
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 HYPOPRESSIVE ABDOMINAL GYMNASTIC
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.

Locations

Country Name City State
Spain Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla Sevilla

Sponsors (1)

Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Available f — View Citation

Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;(9):CD001929. doi: 10.1002/14651858.CD001929.pub3. Review. — View Citation

Resende AP, Torelli L, Zanetti MR, Petricelli CD, Jármy-Di Bella ZI, Nakamura MU, Araujo Júnior E, Moron AF, Girão MJ, Sartori MG. Can Abdominal Hypopressive Technique Change Levator Hiatus Area?: A 3-Dimensional Ultrasound Study. Ultrasound Q. 2016 Jun;3 — View 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 con — View Citation

Stüpp 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: 10.100 — View 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. doi: 10-1123/jsr.2014-0215. Epub 2014 Dec 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary Change from Self-reported lumbar pain intensity at 5 weeks. Measured by the Oswestry disability index. After the last treatment session (fifth week).
Primary 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)
Primary Change from Disability at 5 weeks. Measured by the Oswestry disability index. After the last treatment session (fifth week).
Secondary 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)
Secondary Change from Lumbar joint mobility at 5 weeks. Lumbar flexion measured by the modified Schober test After the last treatment session (fifth week).
Secondary 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)
Secondary Change from Quality of life at 5 weeks. Measured by the Short-Form-12 Health Survey After the last treatment session (fifth week).
See also
  Status Clinical Trial Phase
Completed NCT02273908 - PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
Completed NCT03108339 - Markers of Outcome - a Cohort Study of LBP in Primary Health Care