The Effect of Diaphragm Muscle Training on Chronic Low Back Pain (LBP_DT)

December 5, 2018 updated by: Tamás Bender, Szeged University
Brief Summary: Low back pain is very common problem in all the developed countries and affects children to elderly. Based on the etiology the low back pain is divided into two type: nonspecific and specific low back pain. If the pathological reason is known it is defined as specific and if the reason for the pain is unknown it is defined as nonspecific low back pain. The postulated reason for nonspecific low back pain is the segmental instability of the lumbar spine. Diaphragm muscle has a role in maintaining the segmental stability. The aim of this study to reduce the severity of the low back pain with improving the stability of the lumbar spine by using diaphragm training.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study is a randomized controlled trial. The participants are divided randomly into two groups. One of the groups take part in a complex training which contains stretching, strengthening, mobilizing exercises and proprioceptive training and this training is completed by diaphragm strengthening exercises. This group is defined as diaphragm training group. The members of the diaphragm training group use the POWERbreathe Medic Plus device. Opposed to the diaphragm training group the members of the control group take part only in the complex training without strengthening the diaphragm muscle. The pain intensity is assessed by Visual Analogue Scale and the diameter of the stabilizer muscles' belly is measured by B-mode ultrasound examination, using Zonare Z.One Ultrasound System (Mountain View, CA, USA). The thickness of the transversus abdominis muscle, the lumbar multifidus muscle and the diaphragm muscle is assessed in two different positions: during lying and during sitting position with weightlifting. The muscles are measured in two different states: a relaxed and a contracted state. Functional tests and a balance platform (NeuroCom) are used to measure the stability, and the function of the diaphragm is assessed by using a POWERbreathe KH2 device.

Study Type

Interventional

Enrollment (Anticipated)

100

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

  • Hungary
      • Szeged, Hungary, 6726
        • Recruiting
        • SZTE-Egészségtudományi és Szociális Képzési Kar
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic low back pain
  • Do not take part in other treatment
  • Be able to learn the usage of diaphragm trainer

Exclusion Criteria:

  • Balance problems with neurological cause
  • Malignant tumor
  • Serious organ disease
  • Respiratory disease
  • A previous surgical intervention which affected the trunk
  • The patient is unable to cooperate

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group -complex training
complex training
Other: Complex training
The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.
Active Comparator: Experimental group -diaphragm training
diaphragm training
Other: Complex training
The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.
Other: Diaphragm training
The training program contains strengthening exercises on the diaphragm muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)
Time Frame: 8 weeks
The severity of the pain is measured with Visual Analogue Scale (VAS) before and after the intervention. This is a semi-objective, self-report device that is used extensively to measure such complaints as pain. The sclale is a 10 cm line. The scale is anchored by 'no pain' (0 score) and 'worst imaginable pain' (score of 10). Therefore the higher values represent a worse outcome. When using the Visual Analogue Scale, the participants had to mark on a 10 cm long line the average severity of lumbar pain and we measured the distance of their mark from the zero point in cm-s.
8 weeks
Thickness of the stabilizer muscles' belly
Time Frame: 8 weeks
The thickness of the stabilizer muscles's belly is measured with an ultrasound examination (Zonare Z.One Ultrasound System). The assessed muscles are transversus abdominis muscle, diaphragm muscle and lumbar multifidus muscle before and after the intervention.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscles' function
Time Frame: 8 weeks
Respiratory muscles' function is measured with POWERbreathe KH2 device before and after the intervention.
8 weeks
Limits of stability in sitting
Time Frame: 8 weeks
It is measured by modified Functional and Lateral Reach Test before and after the intervention. Modified means the sitting position.
8 weeks
Functional skills
Time Frame: 8 week
The functional skills are measured by the standard Timed Up and Go Test, Four Square Step Test and Fingertip to Toe Test before and after the intervention.
8 week
Balance and stability
Time Frame: 8 weeks
The balance and the stability of the participants is measured with a force platform (NeuroCom Basic Balance Master) using CTSIB and Unilateral Stance protocol before and after the intervention.
8 weeks

Collaborators and Investigators

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

Sponsor

Szeged University

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)

September 4, 2017

Primary Completion (Actual)

September 30, 2018

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBP_DT_001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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