Clinical trial NCT03600207: The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
Official title: The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Diaphragm
Keywords: Low Back Pain
Diaphragm
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain assessed by Visual Analogue Scale (followed by its scale information in the Description)
timeFrame: 8 weeks
measure: Thickness of the stabilizer muscles' belly
timeFrame: 8 weeks
Secondary outcomes:
measure: Respiratory muscles' function
timeFrame: 8 weeks
measure: Limits of stability in sitting
timeFrame: 8 weeks
measure: Functional skills
timeFrame: 8 week
measure: Balance and stability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: SZTE-Egészségtudományi és Szociális Képzési Kar
Study officials:
References: