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

NCT04415021 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E.1060
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Recurrent

Keywords

Low Back Pain; Diaphragm; iliopsoas; Myofascial Release

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and 4 weeks

• 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.

  Baseline and 4 weeks

• 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

  Baseline and 4 weeks

• 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.

  Baseline and 4 weeks

Secondary Outcomes (3)

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

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

  Baseline and 4 weeks

Study Arms (2)

Diaphragmatic and İliopsoas Myofascial Release Techniques

EXPERIMENTAL

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

Sham Myofascial Release Techniques

SHAM COMPARATOR

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

Interventions

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.

Diaphragmatic and İliopsoas Myofascial Release Techniques

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.

Sham Myofascial Release Techniques

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ümit SIĞLAN: lead
• Istanbul Medipol University Hospital: collaborator

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 23725488 RESULT

• 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.

  PMID: 25603749 RESULT

• 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.

  PMID: 22236541 RESULT

• 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.

  PMID: 23727158 RESULT

• 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.

  PMID: 27333481 RESULT

• 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.

  PMID: 30368336 RESULT

• 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.

  PMID: 5911492 RESULT

• 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.

  PMID: 24175597 RESULT

• 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.

  PMID: 25550670 RESULT

• 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.

  PMID: 19672224 RESULT

• Savage RA, Whitehouse GH, Roberts N. The relationship between the magnetic resonance imaging appearance of the lumbar spine and low back pain, age and occupation in males. Eur Spine J. 1997;6(2):106-14. doi: 10.1007/BF01358742.

  PMID: 9209878 RESULT

• Siglan U, Colak S. Effects of diaphragmatic and iliopsoas myofascial release in patients with chronic low back pain: A randomized controlled study. J Bodyw Mov Ther. 2023 Jan;33:120-127. doi: 10.1016/j.jbmt.2022.09.029. Epub 2022 Sep 29.

  PMID: 36775506 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ÜMİT SIĞLAN

  İstanbulMUH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: February 1, 2020
• Primary Completion: July 28, 2020
• Study Completion: January 6, 2021
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)