Clinical trial NCT06696300: Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain
Official title: Comparison of the Effects of Foundation and Functional Inspiratory Muscle Training in Addition to Classical Physiotherapy in Non-Specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain, Mechanical
Low Back Pain, Chronic
Non Specific Chronic Low Back Pain
Keywords: Low Back Pain
Respiratory Muscle Strength
Muscle Training
Classical Physiotherapy
Ultrasound
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Selcuk University
First posted: 2024-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. In this study, participants will be randomly divided into 3 groups. The first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. The second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. The third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. Evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. There is no interventional method in the evaluations. Pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. In physical measurements, participant's aerobic capacity will be measured with the 2-Minute Walk Test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the MIP/MEP device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the Biodex balance device, and participants's muscle thickness with an ultrasound.


Eligibility criteria: Inclusion Criteria:

* 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 ≥3,
* Being right-hand dominant.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluation of Sociodemographic Information
timeFrame: Baseline
measure: Evaluation of Sociodemographic Information
timeFrame: Baseline
measure: Evaluation of Sociodemographic Information
timeFrame: Baseline
measure: Assessment of Pain Intensity
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Evaluation of Disability Level
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Respiratory Muscle Strength Assessment
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Diaphragm, Transversus abdominis and Multifidus, Muscle Thickness Evaluation
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
Secondary outcomes:
measure: Physical Activity Assessment
timeFrame: Baseline
measure: Evaluation of Exercise Capacity
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Evaluation of Flexibility
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Lower and Upper Extremity Muscle Strength
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Core Endurance Assessment
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Postural Control Evaluation
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Evaluation of Quality of Life
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Fear of Movement
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Pain Catastrophizing
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Anxiety and Depression
timeFrame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year
measure: Treatment Satisfaction
timeFrame: 10 weeks
measure: Willingness for Treatment
timeFrame: Baseline
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kırşehir Ahi Evran University
state: Center
Study officials:
affiliation: Hacettepe University
name: Türkan Akbayrak, Professor
role: STUDY_DIRECTOR
References:
citation: Kolar P, Sulc J, Kyncl M, Sanda J, Cakrt O, Andel R, Kumagai K, Kobesova A. Postural function of the diaphragm in persons with and without chronic low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):352-62. doi: 10.2519/jospt.2012.3830. Epub 2011 Dec 21.
citation: Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
citation: Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018.
citation: Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28.