Actively Recruiting

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

Comparison of Foundation and Functional Inspiratory Muscle Training with 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

102 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

This research aims to compare the effects of basic and functional inspiratory muscle training combined with classical physiotherapy on pain, disability, and functionality in adults with non-specific chronic low back pain. Participants aged 18 to 65 with low back pain lasting at least 3 months and moderate pain levels will be included. The study evaluates how these different treatments impact pain intensity, disability, muscle strength, and muscle thickness over time. Participants will be randomly assigned to one of three groups. The first group receives classical physiotherapy alone, including hotpack, ultrasound, TENS, and basic exercises for 30 sessions over 10 weeks. The second group receives classical physiotherapy plus foundation inspiratory muscle training (IKE) face-to-face and additional home training twice daily, with exercise intensity adjusted weekly. The third group receives classical physiotherapy plus functional inspiratory muscle training (F-ICE), which includes foundation training for the first 4 weeks followed by resisted breathing exercises for 6 weeks, with similar home training and intensity adjustments. Throughout the study, assessments occur before treatment, after 30 sessions, and at 3, 6, and 12 months. Researchers measure pain intensity, disability, respiratory muscle strength, muscle thickness via ultrasound, aerobic capacity, flexibility, muscle endurance and strength, postural control, and quality of life. Participants complete questionnaires on physical activity, fear of movement, pain catastrophizing, anxiety, and depression. Exercise adherence is monitored with diaries, and all these measures help evaluate the treatments' impacts and safety over one year.

CONDITIONS

Official 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
  • Being between the ages of 18-65
  • Having low back pain that has been ongoing for at least 3 months (12 weeks)
  • Having a Visual Analog Scale (VAS) of pain intensity of 6530
  • Being right-hand dominant
Not Eligible

You will not qualify if you...

  • Not volunteering to participate in the study
  • Having a history of cancer
  • Having a spinal infection
  • Having a rheumatological condition
  • Having a spinal fracture
  • Having red flag signs (sudden and unexpected weight loss, fever, etc.)
  • Having a psychological disorder
  • Having a previous spinal surgery
  • Having radiculopathy (neuropathic pain along the lower extremity due to nerve root compression)
  • Not continuing home exercises more than 80%
  • Having an anatomical and congenital abnormality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Kırşehir Ahi Evran University

Kırşehir, Center, Turkey (Türkiye), 40100

Actively Recruiting

Loading map...

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

Similar Trials

A Combined Exercise Programme Involving Strengthening, Flexi...

Low Back Pain, Chronic

Actively Recruiting

1 location

Study Comparing Iovera Lumbar Medial Branch Cryoneurolysis a...

Low Back Pain, Chronic

Actively Recruiting

1 location

Assessment of the Japet.W+ Lumbar Traction Device in Rehabil...

Low Back Pain, Mechanical

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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