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

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: Low Back Pain; Diaphragm
• Intervention / Treatment: Other: Complex training; Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Szeged, Hungary, 6726
    • Recruiting
    • SZTE-Egészségtudományi és Szociális Képzési Kar
    • Contact: Regina Finta; Phone Number: +3662546410; Email: fintaregina@etszk.u-szeged.hu

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscles' function	Respiratory muscles' function is measured with POWERbreathe KH2 device before and after the intervention.	8 weeks
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.	8 weeks
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.	8 week
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.	8 weeks

Collaborators and Investigators

• Sponsor: Szeged University

Study record dates

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: Low Back Pain; Diaphragm
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• 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