Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain

August 7, 2017 updated by: Eva Segura Ortí, Cardenal Herrera University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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

  • Spain
    • Valencia
      • Moncada, Valencia, Spain, 46113
        • University CEU UCH

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • low back pain for more than 3 months

Exclusion Criteria:

  • vertebra fracture
  • systemic disease
  • spinal surgery
  • degenerative articular disease
  • acute soft tissue inflammation
  • radiculopathy
  • structural spine deformities
  • pregnancy
  • mental disease
  • dermatologic disease
  • rejection to manual contact

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: diaphragmatic treatment
Subjects in this arm receive different manual techniques for the low back pain and diaphragmatic treatment.
Other: manual therapy with diaphragmatic treatment
Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.
Placebo Comparator: Placebo
Subjects in this arm receive different manual techniques for the low back pain and a sham diaphragmatic treatment.
Other: Placebo treatment
Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 4 weeks
Oswestry Disability Index
4 weeks
Pain
Time Frame: 4 weeks
Short form McGill Pain Questionnaire
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale
Time Frame: 4 weeks
4 weeks
Fear Avoidance Beliefs Questionnaire
Time Frame: 4 weeks
FABQ
4 weeks
Pain Catastropizing Scale
Time Frame: 4 weeks
4 weeks
Satisfaction with treatment Questionnaire
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Cardenal Herrera University

Investigators

  • Study Director: Juan Francisco Lisón, PhD, University CEU UCH

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 (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 22, 2014

First Submitted That Met QC Criteria

January 20, 2015

First Posted (Estimate)

January 21, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU-UCH-125

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.

Clinical Trials on Low Back Pain

Clinical Trials on manual therapy with diaphragmatic treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe