Clinical trial NCT05840380: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
instrumental soft tissue mobilization
flexibility
functionality
quality life
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain intensity
timeFrame: baseline and 4 weeks post-intervention
measure: Pressure pain threshold
timeFrame: baseline and 4 weeks post-intervention
measure: Flexibility
timeFrame: baseline and 4 weeks post-intervention
measure: Proprioception
timeFrame: baseline and 4 weeks post-intervention
measure: Disability
timeFrame: baseline and 4 weeks post-intervention
measure: Quality of life-SF 36
timeFrame: baseline and 4 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük University
Study officials:
affiliation: Karabuk Univercity
name: Metehan YANA PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.