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

NCT06696300 | Recruiting

• 1 other identifier: 2024/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• Evaluation of Sociodemographic Information

  Participants' sociodemographic information form will include body weight (kilogram).

  Baseline

• Evaluation of Sociodemographic Information

  Participants' sociodemographic information form will include, height (centimeter).

  Baseline

• Evaluation of Sociodemographic Information

  Participants' sociodemographic information form will include gender (male/female), age (years), dominant upper extremity (hand with which to eat), location of pain (middle, right, left), severity of pain (VAS), level of education, profession, occupational activity status, exercise habits (yes/no), alcohol and cigarette consumption (yes/no), family history, personal history, accompanying illnesses and medications used. Participants' body mass indexes will be calculated using the kg/m2 formula and recorded.

  Baseline

• Assessment of Pain Intensity

  Pain intensity will be measured with Visual Analog Scale (VAS). VAS asks the patient to mark the intensity of pain he/she has felt during the past week between 0-10 cm (0- I have no pain, 10- I have the most severe pain I can feel). High scores indicate severe pain. VAS is a valid and reliable method for determining the intensity of pain in individuals with NSCLBP.

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

• Evaluation of Disability Level

  The level of disability will be assessed with the Oswetry Disability Index (ODI). The level of disability due to back pain in patients with limitations in their daily lives and functional movements was assessed with the ODI. The ODI, consisting of 10 questions, questions the patients' travel activities, sexual life, sleep, social life, sitting, walking, standing, pain intensity, lifting and personal care activities. Each question is scored between 0-5 (0- Does not interfere at all, 5- Completely interferes). High scores indicate a high level of disability.

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

• Respiratory Muscle Strength Assessment

  Respiratory muscle strength will be measured before and after interventions for peripheral muscle strength. Respiratory muscle strength will be measured with a portable device (Intraoral pressure measuring device) that can measure intraoral pressure electronically. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be recorded with intraoral pressure measurement, which is a non-invasive method .

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

• Diaphragm, Transversus abdominis and Multifidus, Muscle Thickness Evaluation

  Diaphragm thickness and mobility will be evaluated with ultrasonography Clarius C3HD, (Clarius Mobile Health, BC, Canada). Diaphragm thickness measurements will be made using 8-15 mHz linear probe from 8-9th intercostal space. Functional residual capacity (FRC) level will be measured at the end of maximum expiration and total lung capacity (TLC) level will be measured at the end of maximum inspiration. Thickening ratio will be calculated using end-inspiratory diaphragm thickness/end-expiratory diaphragm thickness formula, and thickening fraction will be calculated using end-inspiratory thickness-end-expiratory thickness/end-expiratory thickness formula. Diaphragm mobility will be evaluated using M-mode during rest and deep inspiration with 1-6 mHz convex probe.

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

Secondary Outcomes (12)

• Physical Activity Assessment

  Baseline

• Evaluation of Exercise Capacity

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

• Evaluation of Flexibility

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

• Lower and Upper Extremity Muscle Strength

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

• Core Endurance Assessment

  Baseline- 10 weeks- 3 Months- 6 Months- 1 Year

Study Arms (3)

Classical Physiotherapy Group

ACTIVE COMPARATOR

Other: Classical Physiotherapy Group

Foundation Inspiratory Muscle Training

EXPERIMENTAL

Other: Classical Physiotherapy Group; Other: Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy

Functional Inspiratory Muscle Training Group

EXPERIMENTAL

Other: Classical Physiotherapy Group; Other: Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy

Interventions

Classical Physiotherapy Group OTHER

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 repetitions and sets will be increased as the tolerance of the patients increases. Pelvic tilt exercises Supine hip flexor stretch Supine lumbar extensor stretch Crunches Cat-Camel Exercises

Classical Physiotherapy Group; Foundation Inspiratory Muscle Training; Functional Inspiratory Muscle Training Group

Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy OTHER

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% MIP for the exercise group. After 10 consecutive respiratory cycles, 3-4 respiratory controls will be asked. As tolerance increases, the consecutive respiratory cycle will be increased. The intensity will be adjusted by taking weekly MIP measurements. Daily monitoring forms will be created for each participant to ensure exercise follow-up.

Foundation Inspiratory Muscle Training

Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy OTHER

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 breathing will be worked simultaneously with the exercises in Table 2 in the last 6 weeks. The exercise program will be continued for a total of 10 weeks, including F-ICE, foundation IKE for the first 4 weeks, and F-ICE for 6 weeks thereafter. The intensity of the exercise will be adjusted to 40-50% MIP for the exercise group. After 10 consecutive respiratory cycles, 3-4 respiratory controls will be requested. As tolerance increases, the number of consecutive respiratory cycles will be increase

Functional Inspiratory Muscle Training Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead
• Hacettepe University: collaborator
• Selcuk University: collaborator

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, Center, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Türkan Akbayrak, Professor

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Fatih Özyurt, Master of Science

CONTACT

5393358469; fatih.ozyurt10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluations will be made by a single evaluator who is unaware of the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, Research Assistant

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 20, 2024
• Study Start: December 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)