NCT03600207

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

1.1 years

First QC Date

June 21, 2018

Last Update Submit

December 5, 2018

Conditions

Low Back PainDiaphragm

Keywords

Low Back PainDiaphragm

Outcome Measures

Primary Outcomes (2)

  • Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)

    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

    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 Outcomes (4)

  • Respiratory muscles' function

    8 weeks

  • Limits of stability in sitting

    8 weeks

  • Functional skills

    8 week

  • Balance and stability

    8 weeks

Study Arms (2)

Control group -complex training

ACTIVE COMPARATOR

complex training

Other: Complex training

Experimental group -diaphragm training

ACTIVE COMPARATOR

diaphragm training

Other: Complex trainingOther: Diaphragm training

Interventions

Complex trainingOTHER

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

Control group -complex trainingExperimental group -diaphragm training
Diaphragm trainingOTHER

The training program contains strengthening exercises on the diaphragm muscle.

Experimental group -diaphragm training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SZTE-Egészségtudományi és Szociális Képzési Kar

Szeged, 6726, Hungary

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tamás Bender, Prof.

CONTACT

+36 14388581bender.tamas@irgalmas.hu

Regina Finta

CONTACT

+3670884435fintaregina@etszk.u-szeged.hu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 26, 2018

Study Start

September 4, 2017

Primary Completion

September 30, 2018

Study Completion

April 1, 2021

Last Updated

December 6, 2018

Record last verified: 2018-12

Locations

HU(1)