Clinical trial NCT06209762: Investigation of the Effects of Inspiratory Muscle Training on Patients With Mechanical Low Back Pain.
Official title: Investigation of the Effects of Inspiratory Muscle Training in Addition to Core Stabilization Exercises on Core Endurance, Functional Capacity, Pain Intensity, Disability, Quality of Life and Sleep Quality in Patients With Mechanical Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Mechanical Low Back Pain
Inspiratuar Muscle Training
Core Stabilization Exercise
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are many conservative treatment methods for the treatment of mechanical low back pain and they continue to be developed. The aim of this study is to examine the effects of inspiratory muscle training, which can be added to these treatment methods, on muscle endurance, functional capacity, pain intensity, disability, quality of life and sleep quality in people with mechanical low back pain.

Detailed description: When initial assessment will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).

All participants will receive the core stabilization exercise program designed for mechanical low back pain for 8 weeks. Additionally, the study group will receive inspiratory muscle training for 8 weeks.

All studies will be evaluated both at the beginning and end of the study in terms of pain, quality of life, sleep quality, disability level, muscle endurance and functional capacity. All data will be collected by the same physiotherapist at baseline and at the end of the study (8 weeks). The same physiotherapist will also supervise the exercises and inspiratory training.

Eligibility criteria: Inclusion Criteria:

* To be between the ages of 18-65
* Applying to the physical therapy unit with the diagnosis of mechanical low back pain (Lumbal disc herniation, spinal stenosis, spondylolisthesis, facet joint pain, discogenic pain, sacroiliac joint pain, myofascial pain, lumbar osteoarthrosis)
* Ability to adapt to exercise commands and understand assessment questions
* Volunteering to participate in research

Exclusion Criteria:

* Those with cooperation and communication problems
* Complaining of acute or chronic musculoskeletal pain other than low back pain
* Having a chronic disease (hypertension, diabetes, chronic obstructive pulmonary disease (COPD), previous cerebrovascular accident (CVO), heart, neurological and rheumatological problems)
* Sequestrated and extruded hernia
* Receiving physical therapy in the last 2 months
* Having a history of recent surgery (spine, abdomen, upper and lower extremity surgeries)
* Being obese (Body mass index ≥30 kg/m2)
* Contagious and vascular diseases

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 8 weeks
measure: Oswestry Disability Index
timeFrame: 8 weeks
measure: Maximum Inspiratuar Pressure
timeFrame: 8 weeks
measure: Core Activation
timeFrame: 8 weeks
measure: 2 Minute Walking Test
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
measure: Short-Form 12
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ataşehir
country: Turkey
facility: Yeditepe University
state: İstanbul
Study officials:
References: