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

NCT ID: NCT06209762

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-26
• Study Completion Date: 2024-03-19

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.

Conditions

Mechanical Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yeditepe University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yeditepe University

Ataşehir, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GulceB

Identifier Type: -

Identifier Source: org_study_id