Diaphragmatic Release for Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKarabuk University
About this trial
Low back pain is one of the most common musculoskeletal disorders, significantly affecting the quality of life of individuals. In non-specific low back pain, a lack of stabilization in the core region negatively impacts the performance of activities. The diaphragm forms the framework of the core region, and its dysfunction can contribute to both respiratory problems and low back pain. This study will investigate the effects of diaphragm relaxation, added to spinal stabilization exercises, on pain, disability, quality of life, central sensitization, and trunk muscle endurance.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Being between 18-65 years of age
Having been diagnosed with chronic non-specific lower back pain (pain between the gluteal folds and the 12th ribs lasting at least 12 weeks and without a known pathoanatomical cause)
Being willing to participate in the study
Disqualifiers
Psychological disorders, mental disorders, cancer, and severe depression
History of primary or metastatic spinal malignancy or spinal fracture
Neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson's, etc.)
Having been diagnosed with advanced osteoporosis
Trial design
Design model
Parallel
Treatments tested in this trial
Manual diaphragm release
Other interventionIn addition to spinal stabilization exercises, patients will perform diaphragmatic relaxation exercises three days a week for eight weeks.
Control
Other interventionPatients will undergo spinal stabilization exercises three times a week for eight weeks.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Pain severity
The severity of back pain will be assessed using the Visual Analog Scale (VAS). Patients choose the appropriate score between 0 and 10. Higher scores indicate higher pain levels.
Time frame
Baseline, After intervention (eight week later)2
Central sensitization
Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.
Time frame
Baseline, After intervention (eight week later)3
Disability levels
Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.
Time frame
Baseline, After intervention (eight week later)4
Quality of life level
In the SF-36 quality of life assessment, each sub-parameter is scored on a scale of 0. 0 is the lowest score and 100 is the highest.
Time frame
Baseline, After intervention (eight week later)Sponsors and contacts
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Source ClinicalTrials.gov