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Completed

NCT Number: NCT06209762

Investigation of the Effects of Inspiratory Muscle Training on Patients With Mechanical Low Back Pain.

There are many conservative treatment methods for the treatment of mechanical low back pain and they continue to be developed. The aim of this study is to examine the effects of inspiratory muscle training, which can be added to these treatment methods, on muscle endurance, functional capacity, pain intensity, disability, quality of life and sleep quality in people with mechanical low back pain.

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Key information

Conditions

Mechanical Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University

Ataşehir, Istanbul, Turkey (Türkiye)

About this study

When initial assessment will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).

All participants will receive the core stabilization exercise program designed for mechanical low back pain for 8 weeks. Additionally, the study group will receive inspiratory muscle training for 8 weeks.

All studies will be evaluated both at the beginning and end of the study in terms of pain, quality of life, sleep quality, disability level, muscle endurance and functional capacity. All data will be collected by the same physiotherapist at baseline and at the end of the study (8 weeks). The same physiotherapist will also supervise the exercises and inspiratory training.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be between the ages of 18-65
  • Applying to the physical therapy unit with the diagnosis of mechanical low back pain (Lumbal disc herniation, spinal stenosis, spondylolisthesis, facet joint pain, discogenic pain, sacroiliac joint pain, myofascial pain, lumbar osteoarthrosis)
  • Ability to adapt to exercise commands and understand assessment questions
  • Volunteering to participate in research

Exclusion criteria

  • Those with cooperation and communication problems
  • Complaining of acute or chronic musculoskeletal pain other than low back pain
  • Having a chronic disease (hypertension, diabetes, chronic obstructive pulmonary disease (COPD), previous cerebrovascular accident (CVO), heart, neurological and rheumatological problems)
  • Sequestrated and extruded hernia
  • Receiving physical therapy in the last 2 months
  • Having a history of recent surgery (spine, abdomen, upper and lower extremity surgeries)
  • Being obese (Body mass index ≥30 kg/m2)
  • Contagious and vascular diseases

Treatment and study plan

Exercise

Other

The core stabilization exercise program, which is individually prescribed and structured, will be applied for 8 weeks. The level of exercises will be increased over time according to the patient's condition. Exercises will be taught to patients. It will be carried out under the supervision of a physiotherapist three days a week for 8 weeks. On the remaining days, the patient will be asked to do it himself.

Primary outcomes

  1. Visual Analog Scale

    Time frame: 8 weeks

    Pain intensity will be measured with this scale.

  2. Oswestry Disability Index

    Time frame: 8 weeks

    Disability level will be measured with this scale

  3. Maximum Inspiratuar Pressure

    Time frame: 8 weeks

    It will be used to evaluate participants' inspiratory muscle strength.

  4. Core Activation

    Time frame: 8 weeks

    It will be used to evaluate the participants' core muscle strength.

  5. 2 Minute Walking Test

    Time frame: 8 weeks

    It will be used to evaluate the functional capacity of participants.

  6. Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

    It will be used to evaluate participants' sleep quality.

  7. Short-Form 12

    Time frame: 8 weeks

    It will be used to evaluate participants' quality of life.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

Investigation of the Effects of Inspiratory Muscle Training in Addition to Core Stabilization Exercises on Core Endurance, Functional Capacity, Pain Intensity, Disability, Quality of Life and Sleep Quality in Patients With Mechanical Low Back Pain.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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