The Effect of Diaphragm Muscle Training on Chronic Low Back Pain

NCT ID: NCT03600207

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Back Pain Diaphragm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group -complex training

complex training

Group Type ACTIVE_COMPARATOR

Complex training

Intervention Type OTHER

The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.

Experimental group -diaphragm training

diaphragm training

Group Type ACTIVE_COMPARATOR

Complex training

Intervention Type OTHER

The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.

Diaphragm training

Intervention Type OTHER

The training program contains strengthening exercises on the diaphragm muscle.

Interventions

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Complex training

The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.

Intervention Type OTHER

Diaphragm training

The training program contains strengthening exercises on the diaphragm muscle.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Szeged University

OTHER

Sponsor Role lead

Responsible Party

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Tamás Bender

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SZTE-Egészségtudományi és Szociális Képzési Kar

Szeged, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Tamás Bender, Prof.

Role: CONTACT

+36 14388581

Regina Finta

Role: CONTACT

+3670884435

Facility Contacts

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Regina Finta

Role: primary

+3662546410

Other Identifiers

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LBP_DT_001

Identifier Type: -

Identifier Source: org_study_id

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