Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Classical Physiotherapy Group, Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy, Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy.
- Who it may be relevant to
- Registry conditions: Low Back Pain, Mechanical, Low Back Pain, Chronic, Non Specific Chronic Low Back Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Classical Physiotherapy Group
Classical physiotherapy group (CF) will be treated face to face for 30 sessions in total, 3 days a week, 10 weeks. Hotpack, Ultrasound, TENS and Basic Exercises will be applied to the CF group. Hotpack will be applied superficially to the lumbar region for 15 minutes. Ultrasound 1MHz- 1.5 Wt/cm2 will be applied to the lumbar region. TENS 50 Hz will be applied for 15 minutes, leaving the painful area in the middle. Basic exercises will be applied as 8-12 repetitions, 2 sets. The number of repetit - Other Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy
In addition to Classical Physiotherapy, Foundation Inspiratory Muscle Training (IKE) will be treated face to face for 30 sessions, 3 days a week, 10 weeks. On other days, IKE will be applied at home for 15 minutes in the morning and evening for a total of 30 minutes and will be followed up with a diary. IKE will be applied with a device that can load with threshold pressure. The IKE group will continue the exercise program for 10 weeks. The intensity of the exercise will be adjusted to 40-50% MI - Other Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy
Functional Inspiratory Muscle Training Group will receive functional inspiratory muscle training in addition to classical physiotherapy, 3 days a week, 10 weeks, 30 sessions in total, face-to-face treatment. On other days, foundation-ICE will be applied at home for 15 minutes in the morning and evening, for a total of 30 minutes, and will be followed with a diary. The same protocol will be applied with the foundation IKE group for teaching the respiratory cycle in the first 4 weeks, and resisted
Primary outcome measures
- Evaluation of Sociodemographic Information [Time frame: Baseline]
- Evaluation of Sociodemographic Information [Time frame: Baseline]
- Evaluation of Sociodemographic Information [Time frame: Baseline]
- Assessment of Pain Intensity [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Evaluation of Disability Level [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Respiratory Muscle Strength Assessment [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Diaphragm, Transversus abdominis and Multifidus, Muscle Thickness Evaluation [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
Secondary outcome measures (12)
- Physical Activity Assessment [Time frame: Baseline]
- Evaluation of Exercise Capacity [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Evaluation of Flexibility [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Lower and Upper Extremity Muscle Strength [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Core Endurance Assessment [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Postural Control Evaluation [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Evaluation of Quality of Life [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Fear of Movement [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Pain Catastrophizing [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Anxiety and Depression [Time frame: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
- Treatment Satisfaction [Time frame: 10 weeks]
- Willingness for Treatment [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Kırşehir Ahi Evran University — Kırşehir
Publications
- 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. PMID 22236541
- 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. PMID 20393397
- 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. PMID 30568484
- 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. PMID 30954705
Identifiers
NCT: NCT06696300 · 2024/19