Effects of Functional Inspiratory Muscle Training in Patients With Chronic Non-Specific Low Back Pain

NCT06958744 | Completed

• 1 other identifier: UUFTR01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to investigate the effects of functional respiratory muscle training on diaphragm function, core stabilization, respiratory muscle strength, pain, functional status and quality of life in patients with chronic non-specific low back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Diaphragm Thickness

  Diaphragm thickness (millimeter-mm) will be measured in the supine position with ultrasonography.

  10 weeks

Secondary Outcomes (7)

• The Numeric Rating Scale

  10 weeks

• Chest wall expansion

  10 weeks

• Respiratory muscle strength

  10 weeks

• McGill Core Endurance Test

  10 weeks

• The Oswestry Disability Index

  10 weeks

Study Arms (2)

Functional Inspiratory Muscle Training (FIMT) group

EXPERIMENTAL

Training will be given with the Powerbreath inspiratory muscle training device. Unlike traditional inspiratory muscle training, the exercises given in FIMT aim to integrate the functional capacity of respiratory muscles into daily life activities and include dynamic exercises in different positions with variable resistances. In this respect, it is defined as functional. Preparatory training will be given 4 weeks before starting FIMT: participants will be taught basic respiratory muscle training, respiratory control and exercises, and will be taught to perform the exercises while maintaining the spine in a neutral position. Patients will then be taken to FIMT for 3 days/6 weeks with a physiotherapist. On the other 3 days of the week, only inspiratory muscle training will be performed. The intensity of inspiratory muscle training will be increased from mild to moderate (Mild: Effort level between 20-40% of MIP or between Borg 2-3, Moderate: 50-60% of MIP or Borg 4-6).

Other: Functional Inspiratory Muscle Training (FIMT) group

Control group

ACTIVE COMPARATOR

Thoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program.

Other: Control group

Interventions

Control group OTHER

Thoracic expansion exercise will be performed for 10 weeks. The participant will be asked to practice 4 times a day as a home program.

Control group

Functional Inspiratory Muscle Training (FIMT) group OTHER

Training will be given with the Powerbreath inspiratory muscle training device. Unlike traditional inspiratory muscle training, the exercises given in FIMT aim to integrate the functional capacity of respiratory muscles into daily life activities and include dynamic exercises in different positions with variable resistances. In this respect, it is defined as functional. Preparatory training will be given 4 weeks before starting FIMT: participants will be taught basic respiratory muscle training, respiratory control and exercises, and will be taught to perform the exercises while maintaining the spine in a neutral position. Patients will then be taken to FIMT for 3 days/6 weeks with a physiotherapist. On the other 3 days of the week, only inspiratory muscle training will be performed. The intensity of inspiratory muscle training will be increased from mild to moderate (Mild: Effort level between 20-40% of MIP or between Borg 2-3, Moderate: 50-60% of MIP or Borg 4-6).

Functional Inspiratory Muscle Training (FIMT) group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Low back pain lasting at least 3 months
• Being between the ages of 18 and 55
• Scoring 4 or more on the Numeric Pain Scale for the severity of low back pain
• Having a non-specific origin (not caused by a specific pathology such as -Infection, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome)
• Individuals with inspiratory muscle strength ≥80 mmHg
• Individuals with a forced expiratory volume (FEV1) of 80% or more

You may not qualify if:

• Tumor history
• Spine surgery in the last 12 months
• Spinal pathology (spondylolysis or spondylolisthesis) or concomitant neurological disease or neurological findings in the leg
• Having a chronic systemic disease
• Pregnancy
• Having a disease that affects the lungs and causes breathing problems
• Participation in a physiotherapy program in the last 6 months

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Faculity of Health Sciences, Uskudar University

Istanbul, Ümraniye, 34764, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Population Groups; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Filiz Eyüboğlu

  Uskudar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 6, 2025
• Study Start: April 30, 2025
• Primary Completion: September 17, 2025
• Study Completion: September 17, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)