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

Mechanical Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209762
• Other study ID #: GulceB
• Status: Recruiting
• Phase: N/A
• Start date: December 26, 2023
• Est. completion date: March 19, 2024

Study information

• Verified date: December 2023
• Source: Yeditepe University
• Contact: Gülce Sevval Bagcibasi, B.A.
• Phone: 905495271998
• Email: gulcebagcibasi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 19, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Other:
• Exercise
The core stabilization exercise program, which is individually prescribed and structured, will be applied for 8 weeks. The level of exercises will be increased over time according to the patient's condition. Exercises will be taught to patients. It will be carried out under the supervision of a physiotherapist three days a week for 8 weeks. On the remaining days, the patient will be asked to do it himself.

Locations

Country	Name	City	State
Turkey	Yeditepe University	Atasehir	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

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