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

NCT06209762 | Completed

• 1 other identifier: GulceB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Low Back Pain

Keywords

Mechanical Low Back Pain; Inspiratuar Muscle Training; Core Stabilization Exercise

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Other: Exercise

Inspiratuar Muscle Education Group

EXPERIMENTAL

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

Interventions

Exercise 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.

Control Group; Inspiratuar Muscle Education Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University

Ataşehir, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: December 26, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 19, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

TU (1)