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

Primary Purpose

Low Back Pain, Diaphragm

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Complex training
Diaphragm training
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Diaphragm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SZTE-Egészségtudományi és Szociális Képzési KarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control group -complex training

Experimental group -diaphragm training

Arm Description

complex training

diaphragm training

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Respiratory muscles' function
Respiratory muscles' function is measured with POWERbreathe KH2 device before and after the intervention.
Limits of stability in sitting
It is measured by modified Functional and Lateral Reach Test before and after the intervention. Modified means the sitting position.
Functional skills
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.
Balance and stability
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.

Full Information

First Posted
June 21, 2018
Last Updated
December 5, 2018
Sponsor
Szeged University
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1. Study Identification

Unique Protocol Identification Number
NCT03600207
Brief Title
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
Acronym
LBP_DT
Official Title
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Diaphragm
Keywords
Low Back Pain, Diaphragm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group -complex training
Arm Type
Active Comparator
Arm Description
complex training
Arm Title
Experimental group -diaphragm training
Arm Type
Active Comparator
Arm Description
diaphragm training
Intervention Type
Other
Intervention Name(s)
Complex training
Intervention Description
The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.
Intervention Type
Other
Intervention Name(s)
Diaphragm training
Intervention Description
The training program contains strengthening exercises on the diaphragm muscle.
Primary Outcome Measure Information:
Title
Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)
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.
Time Frame
8 weeks
Title
Thickness of the stabilizer muscles' belly
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Respiratory muscles' function
Description
Respiratory muscles' function is measured with POWERbreathe KH2 device before and after the intervention.
Time Frame
8 weeks
Title
Limits of stability in sitting
Description
It is measured by modified Functional and Lateral Reach Test before and after the intervention. Modified means the sitting position.
Time Frame
8 weeks
Title
Functional skills
Description
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.
Time Frame
8 week
Title
Balance and stability
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamás Bender, Prof.
Phone
+36 14388581
Email
bender.tamas@irgalmas.hu
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Finta
Phone
+3670884435
Email
fintaregina@etszk.u-szeged.hu
Facility Information:
Facility Name
SZTE-Egészségtudományi és Szociális Képzési Kar
City
Szeged
ZIP/Postal Code
6726
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Finta
Phone
+3662546410
Email
fintaregina@etszk.u-szeged.hu

12. IPD Sharing Statement

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The Effect of Diaphragm Muscle Training on Chronic Low Back Pain

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