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Completed

NCT Number: NCT04415021

Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain

The aim of this study is to effectively investigate the relaxation of the diaphragm and iliopsoas muscle with myofascial technique in patients with chronic low back pain.

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Key information

Conditions

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

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Hospital

Istanbul, Turkey (Türkiye)

About this study

Low back pain is a common health problem that can be seen as a symptom and symptom of many diseases in the clinic.

Myofascial release technique is thought to be effective in patients with chronic low back pain. Therefore, when the literature is examined, it has been observed that the myofascial release technique has studies on pain, range of motion, functionality, muscle stiffness and shortness.

This study will be performed on patients with a total of 42 low back pain. The cases will be divided into 2 groups of 21 people by simple random sampling.

Group 1 (control) will be used with sham diaphragm and iliopsoas muscle myofascial release technique and traditional physiotherapy method.

The second group (experiment) will apply the diaphragm and the myofascial release technique of the iliopsoas muscle and the traditional physiotherapy method.

Patients will be treated for 4 weeks. Traditional physiotherapy method will be applied a total of 20 sessions 5 days a week. A total of 12 sessions will be performed, with the myofascial release technique of the diaphragm and iliopsoas muscle applied 3 days a week.

The study focuses on the analysis of the following variables:

Pain : Numerical Pain Scale

Joint Range of Motion: Goniometer

Flexibility: Tape Measure

Pulmonary Function Test: Spirometer

Anxiety and Depression: Beck Depression inventory

Kinesiophobia: Tampa Kinesiophobia Scale

Disability: Roland-Morris Disability Questionnaire

The results of these pre-intervention and post-intervention variables will be compared between the two groups .

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with chronic low back pain diagnosed by the physician between the ages of 20-50
  • Both genders
  • People who have low back pain for 3 months or more
  • Persons who have not received physical therapy application for the past 6 months, who have not used analgesics and non-streoids
  • Volunteer patients

Exclusion criteria

  • Having had surgery for the lumbar region or had a surgical diagnosis
  • Spondylolisthesis and inflammatory symptoms in the spine
  • Pregnant patients
  • Other contraindicated conditions determined by the physician:
  • Those with systemic infections
  • Those with undiagnosed breathing difficulties
  • Those with undiagnosed bowel and bladder problems

Treatment and study plan

Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques

Other

Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles.

Sham Comparator: Sham Myofascial Release Techniques

Other

Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.

Primary outcomes

  1. Change from baseline in range of motin on goniometer at 4 weeks

    Time frame: Baseline and 4 weeks

    The goniometer is an instrument which measures the available range of motion at a joint. If a patient or client is suffering from decreased range of motion in a particular joint, the therapist can use a goniometer to assess what the range of motion is at the initial assessment, and then make sure the intervention is working by using the goniometer in subsequent sessions.

  2. Change from baseline in flexibility on tape measure at 4 weeks

    Time frame: Baseline and 4 weeks

    Tape Measure. This test is used to assess the degree of flexibility of the lumbal region.

  3. Change from baseline in pulmonary function test on the spirometer at 4 weeks

    Time frame: Baseline and 4 weeks

    Spirometer. A spirometer is the main piece of equipment used for basic Pulmonary Function Tests (PFTs). Lung diseases such as asthma, bronchitis, and emphysema can be ruled out from the tests. In addition, a spirometer is often used for finding the cause of shortness of breath, assessing the effect of contaminants on lung function, the effect of medication, and evaluating progress for disease treatment

  4. Change from baseline in pain on the Numeric Rating Scale at 4 weeks

    Time frame: Baseline and 4 weeks

    The Numeric Rating Scale. This scale is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) and can be used for adults and children 10 years old or older.

Secondary outcomes

  1. Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 4 weeks

    Time frame: Baseline and 4 weeks

    Tampa Scale of Kinesiophobia .This scale is used to assess the patients' fear of pain or re-injury due to movement. It consists of 17 items and assesses various factors of fear/avoidance and injury/re-injury in several activities. Total score of the scale varies between 17 and 68 and higher scores represent higher levels of kinesiophobia.

  2. Change from baseline in disability on the Roland-Morris Disability Questionnaire at 4 weeks

    Time frame: Baseline and 4 weeks

    The Roland-Morris Disability Questionnaire. This questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The Roland-Morris Disability Questionnaire has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain.

  3. Change from baseline in anxiety and depression on the Beck Depression Inventory at 4 weeks .

    Time frame: Baseline and 4 weeks

    The Beck Depression Inventory.This inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

Sponsors and collaborators

Lead sponsor

Ümit SIĞLAN

Other

Collaborators

  • Istanbul Medipol University Hospital

Registry information

Official study title

Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain: A Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
May 26, 2022

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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