An interventional study of Complex training and Diaphragm training in Low Back Pain and Diaphragm, sponsored by Szeged University. Status unknown at 1 site in Hungary. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Szeged University · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Szeged University is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
complex training
Other: Complex training
diaphragm training
Other: Complex training · Other: Diaphragm training
The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.
The training program contains strengthening exercises on the diaphragm muscle.
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.
Time frame: 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.
Time frame: 8 weeks
Respiratory muscles' function
Respiratory muscles' function is measured with POWERbreathe KH2 device before and after the intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Szeged University