Instrumental Soft Tissue Mobilization in Patients With Low Back Pain

Low Back Pain Clinical Trial

Official title:

The Effect of Graston Technique on Pain, Proprioception, Flexibility, and Disability in Patients With Chronic Non-specific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05840380
• Other study ID #: Backache
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 15, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• instrumental soft tissue mobilization
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

Locations

Country	Name	City	State
Turkey	Karabük University	Karabük

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 4 weeks post-intervention
Primary	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.	baseline and 4 weeks post-intervention
Primary	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.	baseline and 4 weeks post-intervention
Primary	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.	baseline and 4 weeks post-intervention
Primary	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.	baseline and 4 weeks post-intervention
Primary	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	baseline and 4 weeks post-intervention