Investigation of the Effects of Inspiratory Muscle Training on Patients With Mechanical Low Back Pain.

Not Applicable

Completed

• Conditions: Mechanical Low Back Pain

• Registration Number: NCT06209762
• Lead Sponsor: Yeditepe University

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.

Study Timeline

• Study Start: 2023-12-26
• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-05
• Study First Posted: 2024-01-17
• Primary Completion: 2024-02-20
• Study Completion: 2024-03-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
2 Minute Walking Test	8 weeks	It will be used to evaluate the functional capacity of participants.
Short-Form 12	8 weeks	It will be used to evaluate participants' quality of life.
Visual Analog Scale	8 weeks	Pain intensity will be measured with this scale.
Oswestry Disability Index	8 weeks	Disability level will be measured with this scale
Core Activation	8 weeks	It will be used to evaluate the participants' core muscle strength.
Maximum Inspiratuar Pressure	8 weeks	It will be used to evaluate participants' inspiratory muscle strength.
Pittsburgh Sleep Quality Index	8 weeks	It will be used to evaluate participants' sleep quality.

Trial Locations

Locations (1)

Yeditepe University; 🇹🇷 Ataşehir, İstanbul, Turkey