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

Primary Purpose

Low Back Pain, Recurrent

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques
Sham Comparator: Sham Myofascial Release Techniques
Sponsored by
Ümit SIĞLAN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Recurrent focused on measuring Low Back Pain, Diaphragm, iliopsoas, Myofascial Release

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Diaphragmatic and İliopsoas Myofascial Release Techniques

Sham Myofascial Release Techniques

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in range of motin on goniometer at 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.
Change from baseline in flexibility on tape measure at 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
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
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 Outcome Measures

Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 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.
Change from baseline in disability on the Roland-Morris Disability Questionnaire at 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 .
The Beck Depression Inventory.This inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

Full Information

First Posted
May 27, 2020
Last Updated
May 24, 2022
Sponsor
Ümit SIĞLAN
Collaborators
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04415021
Brief Title
Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain
Official Title
Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
January 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ümit SIĞLAN
Collaborators
Istanbul Medipol University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent
Keywords
Low Back Pain, Diaphragm, iliopsoas, Myofascial Release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic and İliopsoas Myofascial Release Techniques
Arm Type
Experimental
Arm Description
Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles.
Arm Title
Sham Myofascial Release Techniques
Arm Type
Sham Comparator
Arm Description
Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.
Intervention Type
Other
Intervention Name(s)
Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques
Intervention Description
Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles.
Intervention Type
Other
Intervention Name(s)
Sham Comparator: Sham Myofascial Release Techniques
Intervention Description
Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.
Primary Outcome Measure Information:
Title
Change from baseline in range of motin on goniometer at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in flexibility on tape measure at 4 weeks
Description
Tape Measure. This test is used to assess the degree of flexibility of the lumbal region.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in pulmonary function test on the spirometer at 4 weeks
Description
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
Time Frame
Baseline and 4 weeks
Title
Change from baseline in pain on the Numeric Rating Scale at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in disability on the Roland-Morris Disability Questionnaire at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in anxiety and depression on the Beck Depression Inventory at 4 weeks .
Description
The Beck Depression Inventory.This inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ÜMİT SIĞLAN
Organizational Affiliation
İstanbulMUH
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23725488
Citation
McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
Results Reference
result
PubMed Identifier
25603749
Citation
Ajimsha MS, Al-Mudahka NR, Al-Madzhar JA. Effectiveness of myofascial release: systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jan;19(1):102-12. doi: 10.1016/j.jbmt.2014.06.001. Epub 2014 Jun 13.
Results Reference
result
PubMed Identifier
22236541
Citation
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.
Results Reference
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PubMed Identifier
23727158
Citation
Janssens L, Brumagne S, McConnell AK, Hermans G, Troosters T, Gayan-Ramirez G. Greater diaphragm fatigability in individuals with recurrent low back pain. Respir Physiol Neurobiol. 2013 Aug 15;188(2):119-23. doi: 10.1016/j.resp.2013.05.028. Epub 2013 May 31.
Results Reference
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PubMed Identifier
27333481
Citation
Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
Results Reference
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PubMed Identifier
30368336
Citation
Marizeiro DF, Florencio ACL, Nunes ACL, Campos NG, Lima POP. Immediate effects of diaphragmatic myofascial release on the physical and functional outcomes in sedentary women: A randomized placebo-controlled trial. J Bodyw Mov Ther. 2018 Oct;22(4):924-929. doi: 10.1016/j.jbmt.2017.10.008. Epub 2017 Oct 25.
Results Reference
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PubMed Identifier
5911492
Citation
Nachemson A. Electromyographic studies on the vertebral portion of the psoas muscle; with special reference to its stabilizing function of the lumbar spine. Acta Orthop Scand. 1966;37(2):177-90. doi: 10.3109/17453676608993277. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Park RJ, Tsao H, Claus A, Cresswell AG, Hodges PW. Recruitment of discrete regions of the psoas major and quadratus lumborum muscles is changed in specific sitting postures in individuals with recurrent low back pain. J Orthop Sports Phys Ther. 2013 Nov;43(11):833-40. doi: 10.2519/jospt.2013.4840. Epub 2013 Oct 11.
Results Reference
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PubMed Identifier
25550670
Citation
Avrahami D, Potvin JR. The clinical and biomechanical effects of fascial-muscular lengthening therapy on tight hip flexor patients with and without low back pain. J Can Chiropr Assoc. 2014 Dec;58(4):444-55.
Results Reference
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PubMed Identifier
19672224
Citation
Stefanidi AV, Skoromets AA, Dukhovnikova IM. [Acute myofascial low back pain as a consequence of functional disorganization between flexors and extensors of the body]. Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(6):33-7. Russian.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain

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