Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06696300

Comparison of Foundation and Functional Inspiratory Muscle Training Added to Classical Physiotherapy in Non-Specific Chronic Low Back Pain

Led by Kirsehir Ahi Evran Universitesi · Updated on 2024-12-31

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

K

Kirsehir Ahi Evran Universitesi

Lead Sponsor

H

Hacettepe University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of basic and functional respiratory muscle training on pain, disability, and functionality in people with non-specific chronic low back pain lasting at least 3 months. The study randomly assigns participants to one of three groups to compare different treatment combinations over 10 weeks. The aim is to better understand how these therapies impact pain levels, disability, physical activity, and quality of life. Participants will be divided into three groups: one receiving only classical physiotherapy, the second combining classical physiotherapy with foundation inspiratory muscle training, and the third combining classical physiotherapy with functional inspiratory muscle training. Physiotherapy includes hotpack, ultrasound, TENS, and basic exercises over 30 face-to-face sessions. The muscle training groups also perform home exercises twice daily, monitored with diaries, with intensity adjusted weekly. Assessments occur before treatment, after 30 sessions, and at 3 months, 6 months, and 1 year. Researchers will measure pain intensity, disability, respiratory muscle strength, and muscle thickness, among other outcomes. Physical tests include aerobic capacity, flexibility, muscle strength, core endurance, and postural control. Questionnaires will evaluate quality of life, fear of movement, anxiety, depression, and treatment satisfaction. This comprehensive monitoring aims to track progress and safety throughout the study duration.

CONDITIONS

Brief Title

Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Volunteering to participate in the study
  • Aged between 18 and 65 years
  • Having low back pain lasting at least 3 months (12 weeks)
  • Pain intensity of 3 or higher on the Visual Analog Scale
  • Right-hand dominant
Not Eligible

You will not qualify if you...

  • Not volunteering to participate in the study
  • History of cancer
  • Spinal infection
  • Rheumatological condition
  • Spinal fracture
  • Presence of red flag signs such as sudden weight loss or fever
  • Psychological disorder
  • Previous spinal surgery
  • Radiculopathy (nerve-related lower extremity pain)
  • Not completing home exercises at least 80%
  • Anatomical or congenital abnormalities

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 weeks

Participants receive one of three physiotherapy-based treatments for chronic low back pain over a period of 10 weeks. Treatments include classical physiotherapy alone, foundation inspiratory muscle training added to classical physiotherapy, or functional inspiratory muscle training added to classical physiotherapy. Sessions occur face-to-face 3 days a week for a total of 30 sessions. On non-face-to-face days, participants in the inspiratory muscle training groups perform home exercises twice daily and monitor progress with a diary.

3 face-to-face visits per week for 10 weeks; home exercises twice daily on other days

Follow-up

Duration - Up to 1 year post-treatment

Participants are monitored for pain intensity, disability level, respiratory muscle strength, muscle thickness, exercise capacity, flexibility, muscle strength, core endurance, postural control, quality of life, fear of movement, pain catastrophizing, anxiety and depression at 3 months, 6 months, and 1 year after treatment completion.

Visits at 3 months, 6 months, and 1 year after treatment

Trial Site Locations

Total: 1 location

1

Kırşehir Ahi Evran University

Kırşehir, Center, Turkey (Türkiye), 40100

Actively Recruiting

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Research Team

F

Fatih Özyurt, Master of Science

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain.

Lotte Janssens, Simon Brumagne, Kathelijn Polspoel...

https://pubmed.ncbi.nlm.nih.gov/20393397

The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain.

Regina Finta, Edit Nagy, Tamás Bender

https://pubmed.ncbi.nlm.nih.gov/30568484

Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain.

César Calvo-Lobo, Jaime Almazán-Polo, Ricardo Becerro-de-Bengoa-Vallejo...

https://pubmed.ncbi.nlm.nih.gov/30954705