- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05840380
Instrumental Soft Tissue Mobilization in Patients With Low Back Pain
The Effect of Graston Technique on Pain, Proprioception, Flexibility, and Disability in Patients With Chronic Non-specific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low back pain is caused by strain of the ligaments or muscles around the vertebral column or a musculoskeletal system formed due to compression of the nerves coming out of the spinal cord is a system nuisance.The process that begins as acute pain become chronic with prolongation of life, limit physical function and negatively affecting the quality of work, loss of workforce and health care It is an important health problem that causes an increase in expenditures.The most load-bearing region of the spine in the movement system is the lumbar region. from mechanical stresses, functional loads, occupational and sportive It is the area most affected by trauma. In recent years, studies have shown that manual therapy methods can be used to reduce chronic low back pain.
shows that it is a viable treatment option in reducing Instrument assisted soft tissue mobilization (Instrument Assisted Soft Tissue Mobilization, IASTM), is a popular method that can be used for myofascial restriction. is a treatment method. Reducing pain in the area of IASTM pathology, increasing range of motion (ROM), improving motion function and is used to give a mobilizing effect.In the light of studies in the literature, patients with chronic non-specific low back pain Instrumental soft tissue mobilization to be applied will reduce pain, joint range of motion, flexibility, functionality and quality of life positively is thought to develop.Thirty patients (mean age; 38.46±9.03 years) with CNLBP were included in the study. The patients have randomly divided into two groups Graston technique (GT) and control. Graston was applied three times a week for four weeks in addition to the exercise program in the GT group, while only the exercise program was applied to the control group. Pain intensity (Visual analog scale), pressure pain threshold (algometer), proprioception (digital inclinometer), flexibility (sit and reach test), disability (Oswestry disability index), and quality of life (Short form-36) were evaluated at the beginning and end of the study.This study aims to investigate the effect of the Graston technique added to exercise on pain, proprioception, disability, flexibility, and quality of life in individuals with chronic non-specific low back pain (CNLBP).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mus GÜNEŞ MsC
- Phone Number: 05315132482
- Email: musagunes52@hotmail.com
Study Contact Backup
- Name: Metehan YANA Phd
- Phone Number: 05072665522
- Email: metehanyana@karabuk.edu.tr
Study Locations
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-
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Karabük, Turkey, 78000
- Karabuk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be between the ages of 18-60
- Being diagnosed with chronic non-specific low back pain
- Volunteer to participate in the study
Exclusion Criteria:
- Psychological disorder, mental disorder, cancer and severe depression to have situations
- Primary or metastatic spinal malignancy, history of spinal fracture
- Neurological disease (Hemiplegia, Multiple Sclerosis, Parkinson, etc.)
- Having been diagnosed with advanced osteoporosis
- Surgery or acute infection of the lumbar region to be
- Patients using regular analgesics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: exercise+1ASTM group
In addition to the exercises given to the exercise group to the IASTM group 8-10 repetitions with the device at a 45° angle twice a week for 4 weeks on erector spines, glutes maximus, gluteus medius and hamstrings Superficial and deep fascia will be applied. Individual supine for application will be deposited. The Graston instrument glides over the tissues of the individual. cream will be applied to make it easier, then the physiotherapist will will stand on its side at the level and graston for 5 minutes. superficially on the thoracolumbal fascia between the sacrum and T12. will be applied. They will perform the low back pain exercises shown. Pain intensity of all patients at the beginning and end of treatment Visual Analogue Scale and algometer, flexibility sit and lie test, position sense digital inclinometer, functional status Oswestry Disability Index and life Quality will be evaluated with Short Form-36 (SF-36). |
Individual supine for application will be deposited.
The Graston instrument glides over the tissues of the individual.
cream will be applied to make it easier, then the physiotherapist will will stand on its side at the level and graston for 5 minutes.
superficially on the thoracolumbal fascia between the sacrum and T12. will be applied
Other Names:
|
Active Comparator: exercise group
The exercise group is; By physiotherapists 3 times a week for 4 weeks They will perform the low back pain exercises shown.
Pain intensity of all patients at the beginning and end of treatment Visual Analogue Scale and algometer, flexibility sit and lie test, position sense digital inclinometer, functional status Oswestry Disability Index and life Quality will be evaluated with Short Form-36 (SF-36).
|
Individual supine for application will be deposited.
The Graston instrument glides over the tissues of the individual.
cream will be applied to make it easier, then the physiotherapist will will stand on its side at the level and graston for 5 minutes.
superficially on the thoracolumbal fascia between the sacrum and T12. will be applied
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: baseline and 4 weeks post-intervention
|
Low back pain severity was measured using the Visual Analog Scale.
Scale (VAS).
The VAS is a 10 cm scale, where 0 represented no pain and 10 represented unbearable pain.
Pain intensity was recorded by measuring the point marked between 0- 10.
|
baseline and 4 weeks post-intervention
|
Pressure pain threshold
Time Frame: baseline and 4 weeks post-intervention
|
Pressure pain threshold (PPT) was measured using an algometer.
Algometer is a device that measures sensitivity to pain caused by pressure or force applied to any part of the body.
The algometer was placed vertically 2 cm lateral to the 3rd lumbar vertebra, and then the pressure was applied to the area at a rate of 1 kg/s.
The point at which the patient felt an unpleasant sensation or pain was accepted as the pressure pain threshold.
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baseline and 4 weeks post-intervention
|
Flexibility
Time Frame: baseline and 4 weeks post-intervention
|
Sit and Reach Flexibility Test was used to evaluate trunk and hamstring muscle flexibility.
Patients rested their feet on the sit-and-reach table with their knees extended.
Then, they were asked to lie forward with their hands together without lifting their knees.
The test was repeated 3 times and the best distance the patient reached was recorded.
|
baseline and 4 weeks post-intervention
|
Proprioception
Time Frame: baseline and 4 weeks post-intervention
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The sense of position, known as the sense of repositioning of the trunk, was evaluated with a digital inclinometer.
The inclinometer was placed on the lumbar spinous processes while the patients stood upright.
For trial and learning, they were asked to bend forward three times at 15° and 30° with their eyes closed and stop there for 3 seconds.
The same procedure was applied after the trial, and the patients repeated the test 3 times.
Deviation angles were recorded for 15° and 30° trunk flexion.
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baseline and 4 weeks post-intervention
|
Disability
Time Frame: baseline and 4 weeks post-intervention
|
The Oswestry Disability Index (ODI) was used to evaluate the level of functional disability caused by chronic low back pain [23].
The scale has ten subgroups.
Subgroups of the scale: severity of pain, lifting and carrying, walking, sitting, standing, sleep, sexual life, traveling and social life.
Each subgroup has six options, and the first statement is scored as "0" and the sixth statement as "5".
As the total score increases, the level of disability also increases.
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baseline and 4 weeks post-intervention
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Quality of life-SF 36
Time Frame: baseline and 4 weeks post-intervention
|
The Short Form-36 (SF-36) was used to measure changes in quality of life (QoL) levels due to chronic low back pain.
This scale consists of 36 items and includes physical function, physical role, bodily pain, general health, emotional role, social function, mental health, and vitality sub-parameters
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baseline and 4 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Metehan YANA PhD, Karabuk Univercity
Publications and helpful links
General Publications
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
- Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010 Apr 8;8:22. doi: 10.1186/1741-7015-8-22.
- Moffett J, McLean S. The role of physiotherapy in the management of non-specific back pain and neck pain. Rheumatology (Oxford). 2006 Apr;45(4):371-8. doi: 10.1093/rheumatology/kei242. Epub 2005 Dec 6.
- Davis KG, Marras WS. The effects of motion on trunk biomechanics. Clin Biomech (Bristol, Avon). 2000 Dec;15(10):703-17. doi: 10.1016/s0268-0033(00)00035-8.
- Meier ML, Vrana A, Schweinhardt P. Low Back Pain: The Potential Contribution of Supraspinal Motor Control and Proprioception. Neuroscientist. 2019 Dec;25(6):583-596. doi: 10.1177/1073858418809074. Epub 2018 Nov 2.
- Tong MH, Mousavi SJ, Kiers H, Ferreira P, Refshauge K, van Dieen J. Is There a Relationship Between Lumbar Proprioception and Low Back Pain? A Systematic Review With Meta-Analysis. Arch Phys Med Rehabil. 2017 Jan;98(1):120-136.e2. doi: 10.1016/j.apmr.2016.05.016. Epub 2016 Jun 16.
- Descarreaux M, Blouin JS, Teasdale N. Repositioning accuracy and movement parameters in low back pain subjects and healthy control subjects. Eur Spine J. 2005 Mar;14(2):185-91. doi: 10.1007/s00586-004-0833-y. Epub 2004 Nov 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Backache
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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