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Instrumental Soft Tissue Mobilization in Patients With Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
instrumental soft tissue mobilization
Sponsored by
Karabuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, instrumental soft tissue mobilization, flexibility, functionality, quality life

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karabük UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

exercise+1ASTM group

exercise group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Pain intensity
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.
Pressure pain threshold
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.
Flexibility
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.
Proprioception
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.
Disability
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.
Quality of life-SF 36
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

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
October 4, 2023
Sponsor
Karabuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05840380
Brief Title
Instrumental Soft Tissue Mobilization in Patients With Low Back Pain
Official Title
The Effect of Graston Technique on Pain, Proprioception, Flexibility, and Disability in Patients With Chronic Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karabuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, instrumental soft tissue mobilization, flexibility, functionality, quality life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise+1ASTM group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
exercise group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
instrumental soft tissue mobilization
Other Intervention Name(s)
exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
baseline and 4 weeks post-intervention
Title
Pressure pain threshold
Description
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.
Time Frame
baseline and 4 weeks post-intervention
Title
Flexibility
Description
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.
Time Frame
baseline and 4 weeks post-intervention
Title
Proprioception
Description
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.
Time Frame
baseline and 4 weeks post-intervention
Title
Disability
Description
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.
Time Frame
baseline and 4 weeks post-intervention
Title
Quality of life-SF 36
Description
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
Time Frame
baseline and 4 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mus GÜNEŞ MsC
Phone
05315132482
Email
musagunes52@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Metehan YANA PhD
Phone
05072665522
Email
metehanyana@karabuk.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Metehan YANA PhD
Organizational Affiliation
Karabuk Univercity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karabük University
City
Karabük
ZIP/Postal Code
78000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Metehan YANA Phd
Phone
05072665522
Email
metehanyana@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Musa GÜNEŞ MsC
Phone
05315132482
Email
musagunes52@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21982256
Citation
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.
Results Reference
background
PubMed Identifier
16332949
Citation
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.
Results Reference
background
PubMed Identifier
11050352
Citation
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.
Results Reference
background
PubMed Identifier
30387689
Citation
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.
Results Reference
background
PubMed Identifier
27317866
Citation
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.
Results Reference
background
PubMed Identifier
20377854
Citation
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.
Results Reference
background
PubMed Identifier
15759173
Citation
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.
Results Reference
background
PubMed Identifier
1593914
Citation
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.
Results Reference
background

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Instrumental Soft Tissue Mobilization in Patients With Low Back Pain

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