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Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

NCT02343185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-08-08

No results posted yet for this study

Summary

This study is a double-blind randomized clinical trial with two arms which aims to study the effects of diaphragmatic treatment in patients with nonspecific low back pain.

Low back pain has a great importance in today's society, and it is therefore important to develop an effective treatment for this condition. People with chronic nonspecific low back pain, can present respiratory disorders and get anxiety states, affecting mainly the diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be part of the development of chronic low back pain. Although clinical practice guidelines for chronic low back pain have been developed, it hasn't been explored before a physiotherapy treatment especially aimed at a diaphragmatic treatment.

A double-blind randomized clinical trial with two arms will be used for this purpose, 64 patients with nonspecific low back pain referred from different hospitals of Castellón will be randomized into two groups:

* Diaphragmatic intervention with osteopathic manual therapy treatment (D).
* Diaphragmatic intervention with placebo treatment group (P).

An osteopathic manual therapy protocol for the treatment of back pain including techniques for the diaphragm muscle will be applied to the patients in group D, in a total of 5 sessions. For patients in group P, the same protocol will be performed on the diaphragm but with placebo treatment techniques.

The study focuses on the analysis of the following variables: scores on the questionnaires:

* Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).
* Fear Avoidance: (FABQ)
* Disability: Oswestry Disability Index and Roland-Morris
* Anxiety: HADS: (Hospital Anxiety and Depression Scale)
* Catastropizing: PCS (Pain Catastropizing Scale)
* Satisfaction with treatment (Escala de Satisfacción con el tratamiento)

The results of these pre-intervention and post-intervention variables will be compared between the two groups in the first session, in the fourth session and in the first and third month after the first intervention. The VAS score will also be assessed in the second and third session.

Conditions

  • Low Back Pain

Interventions

OTHER

manual therapy with diaphragmatic treatment

Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.

OTHER

Placebo treatment

Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.

Sponsors & Collaborators

  • Cardenal Herrera University

    lead OTHER

Principal Investigators

  • Juan Francisco Lisón, PhD · University CEU UCH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343185 on ClinicalTrials.gov