Instrumental Soft Tissue Mobilization in Patients With Low Back Pain

Sponsor
Karabuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05840380
Collaborator
(none)
30
1
2
4.4
6.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: instrumental soft tissue mobilization
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
The Effect of Graston Technique on Pain, Proprioception, Flexibility, and Disability in Patients With Chronic Non-specific Low Back Pain
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

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).

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
Other Names:
  • exercise
  • 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).

    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
    Other Names:
  • exercise
  • Outcome Measures

    Primary Outcome Measures

    1. Pain intensity [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.

    2. Pressure pain threshold [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.

    3. Flexibility [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.

    4. Proprioception [baseline and 4 weeks post-intervention]

      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.

    5. Disability [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.

    6. Quality of life-SF 36 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karabük University Karabük Turkey 78000

    Sponsors and Collaborators

    • Karabuk University

    Investigators

    • Principal Investigator: Metehan YANA PhD, Karabuk Univercity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    METEHAN YANA, Director, Karabuk University
    ClinicalTrials.gov Identifier:
    NCT05840380
    Other Study ID Numbers:
    • Backache
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by METEHAN YANA, Director, Karabuk University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2023