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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Low Back Pain
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gülce Şevval Bağcıbaşı, B.A.; Phone Number: 905495271998; Email: gulcebagcibasi@gmail.com

Study Locations

• Turkey
  • İstanbul
    • Ataşehir, İstanbul, Turkey
      • Recruiting
      • Yeditepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	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.
Experimental: Inspiratuar Muscle Education Group; Patients in this group will have 10 repetitions of slow diaphragmatic deep breathing exercises followed by core stabilization exercises. Then, IMT will be applied with a respiratory muscle training device. In this training, the difficulty of the exercise will be increased by starting from 40% of the MIP value measured during the evaluation and following the values of 60% and 80% according to tolerance. In addition to physical therapy sessions three days a week for eight weeks, patients will be asked to do this exercise five days a week in the morning and evening.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yeditepe University

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2023
• Primary Completion (Estimated): February 20, 2024
• Study Completion (Estimated): March 19, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical Low Back Pain; Core Stabilization Exercise; Inspiratuar Muscle Training
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: GulceB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No