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

Not Applicable

Completed

• Conditions: Low Back Pain, Recurrent

• Registration Number: NCT04415021
• Lead Sponsor: Ümit SIĞLAN

Brief Summary

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.

Detailed Description

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 .

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-30
• Study First Posted: 2020-06-04
• Primary Completion: 2020-07-28
• Study Completion: 2021-01-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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:

  1. Those with systemic infections
  2. Those with undiagnosed breathing difficulties
  3. Those with undiagnosed bowel and bladder problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in flexibility on tape measure at 4 weeks	Baseline and 4 weeks	Tape Measure. This test is used to assess the degree of flexibility of the lumbal region.
Change from baseline in pulmonary function test on the spirometer at 4 weeks	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
Change from baseline in pain on the Numeric Rating Scale at 4 weeks	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.
Change from baseline in range of motin on goniometer at 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in disability on the Roland-Morris Disability Questionnaire at 4 weeks	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.
Change from baseline in anxiety and depression on the Beck Depression Inventory at 4 weeks .	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.
Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 4 weeks	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.

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Turkey