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

May 24, 2022 updated by: Ümit SIĞLAN

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Medipol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques
Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles.
Other: Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques
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
Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.
Other: Sham Comparator: Sham Myofascial Release Techniques
Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
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
Baseline and 4 weeks
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.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ümit SIĞLAN

Collaborators

Istanbul Medipol University Hospital

Investigators

  • Study Chair: ÜMİT SIĞLAN, İstanbulMUH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

July 28, 2020

Study Completion (Actual)

January 6, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10840098-604.01.01-E.1060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain, Recurrent

Clinical Trials on Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe