Clinical trial NCT04415021: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Recurrent
Keywords: Low Back Pain
Diaphragm
iliopsoas
Myofascial Release
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Istanbul Medipol University Hospital
First posted: 2020-06-04
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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:

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

Primary outcomes:
measure: Change from baseline in range of motin on goniometer at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in flexibility on tape measure at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in pulmonary function test on the spirometer at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in pain on the Numeric Rating Scale at 4 weeks
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change from baseline in kinesiophobia on the Tampa Scale of Kinesiophobia at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in disability on the Roland-Morris Disability Questionnaire at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline in anxiety and depression on the Beck Depression Inventory at 4 weeks .
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
Study officials:
affiliation: İstanbulMUH
name: ÜMİT SIĞLAN
role: STUDY_CHAIR
References:
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.
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.
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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.
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