Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial release
Classical massage
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Low-back Pain focused on measuring Myofascial release, Chronic low back pain, Flexibility
Eligibility Criteria
Inclusion Criteria:
- age between 20 and 55 years;
- low back pain lasting more than 3 months;
- stable clinical status;
- no cognitive and mental problems;
- self-expression ability;
- volunteering to participate in the study.
Exclusion Criteria:
- problems of cooperation;
- malignancy or infection;
- acute fractures;
- occlusive edema;
- osteoporosis;
- advanced degenerative joint problems;
- acute rheumatologic conditions;
- cortisone therapy;
- use of blood thinners;
- skin problems.
Sites / Locations
- Halic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Myofascial release was applied to the experimental group
Classical massage was applied to the control group
Outcomes
Primary Outcome Measures
Change in Visual Analog Scale (VAS) Pain Score
The VAS is a widely used scale for pain assessment in daily practice. VAS, with 0-10 numbers on it and they are asked to give a value between these numbers. 0: I have no pain, 10: I have very severe pain
Change in The Straight Leg Raise Test Score
test was used to assess hamstring flexibility. While the patient is in the supine position, the physiotherapist makes passive hip flexion with the knee straight and the measurement is made with a goniometer.
Change in The Modified Schober Test Score
Test is an assessment method that measures lumbar flexion flexibility. The lumbosacral junction and 10 cm above were marked when the person was in an upright position. Then third mark was placed 5 cm below the lumbosacral junction. After anterior flexion as far forward as possible, the distance between the highest and lowest marks was measured.
Change in Sit and Reach Test Score
test was used for flexibility evaluation. While the patient was performing maximum trunk flexion in the knee extension, the distance between the fingertip and the box aganist the sole of the foot was measured as +/- centimeters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05302882
Brief Title
Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain
Official Title
Evaluation of The Immediate Effect of Myofascial Release Application on Pain, Flexibility and Trunk Mobility in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Halic 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
Purpose: To determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP).
Materials and methods: Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".
Detailed Description
It was aimed to determine the immediate effect of myofascial release application on pain, flexibility and trunk mobility in chronic low back pain (CLBP). Forty patients with CLBP participated in this experimental study. Participants were grouped in randomized control. Visual Analogue Scale (VAS) was used for pain assessment. Sit-Reach Test for flexibility evaluation and Straight Leg Raising Test with goniometric measurement for hamstring flexibility were used. Modified Schober Test was applied to evaluate trunk mobility. Comparison of the pre- and post-treatment evaluation data of the individuals in the same group was made using the "Wilcoxen Sum Rank Test", one of the non-parametric tests. Comparison of pre- and post-treatment evaluation data of both groups was performed using the non-parametric evaluation "Mann-Whitney U Test".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Myofascial release, Chronic low back pain, Flexibility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Myofascial release was applied to the experimental group
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Classical massage was applied to the control group
Intervention Type
Behavioral
Intervention Name(s)
Myofascial release
Intervention Description
The physiotherapist placed both palms on the two right and left ribs at the T12 level and applied continuous stretching to the superior for 2 minutes. After this application, the physiotherapist placed one hand on the sacrum with the other hand on T12 with his hands crossed, and applied rhythmically 2 seconds of stretching and 2 seconds of relaxation for a total of 2 minutes. Then, myofascial release was terminated by applying deep compression to the paraspinal muscles with palms for 2 minutes on the right and 2 minutes on the left side, respectively.
Intervention Type
Behavioral
Intervention Name(s)
Classical massage
Intervention Description
Classical massage was applied to the lumbar region for 9 minutes. Classical massage was applied with the patient in the prone position. A small amount of solid vaseline was taken and a gentle stroke was applied for 1 minute to spread it sufficiently to the lumbar region. Then, superficial stroking was applied to the right paraspinal region for 1 minute from distal to proximal by the physiotherapist. After the same procedure was performed on the right paraspinal region for 1 minute. Then, both hands were placed on the right and left paraspinal region and friction was applied for 2 minutes. Afterwards, the patient's right paraspinal region was kneeding for 1 minute and then the same procedure was applied to the left paraspinal region for 1 minute. As the last procedure, the fingertips of both hands were placed on the right and left paraspinal region and the classical massage was completed by performing 2 minutes of deep euphlorage from the L5-S1 level to the T12 level.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Pain Score
Description
The VAS is a widely used scale for pain assessment in daily practice. VAS, with 0-10 numbers on it and they are asked to give a value between these numbers. 0: I have no pain, 10: I have very severe pain
Time Frame
Baseline, immediately after the intervention
Title
Change in The Straight Leg Raise Test Score
Description
test was used to assess hamstring flexibility. While the patient is in the supine position, the physiotherapist makes passive hip flexion with the knee straight and the measurement is made with a goniometer.
Time Frame
Baseline, immediately after the intervention
Title
Change in The Modified Schober Test Score
Description
Test is an assessment method that measures lumbar flexion flexibility. The lumbosacral junction and 10 cm above were marked when the person was in an upright position. Then third mark was placed 5 cm below the lumbosacral junction. After anterior flexion as far forward as possible, the distance between the highest and lowest marks was measured.
Time Frame
Baseline, immediately after the intervention
Title
Change in Sit and Reach Test Score
Description
test was used for flexibility evaluation. While the patient was performing maximum trunk flexion in the knee extension, the distance between the fingertip and the box aganist the sole of the foot was measured as +/- centimeters
Time Frame
Baseline, immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 20 and 55 years;
low back pain lasting more than 3 months;
stable clinical status;
no cognitive and mental problems;
self-expression ability;
volunteering to participate in the study.
Exclusion Criteria:
problems of cooperation;
malignancy or infection;
acute fractures;
occlusive edema;
osteoporosis;
advanced degenerative joint problems;
acute rheumatologic conditions;
cortisone therapy;
use of blood thinners;
skin problems.
Facility Information:
Facility Name
Halic University
City
Istanbul
State/Province
Eyupsultan
ZIP/Postal Code
2022
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32026838
Citation
Boff TA, Pasinato F, Ben AJ, Bosmans JE, van Tulder M, Carregaro RL. Effectiveness of spinal manipulation and myofascial release compared with spinal manipulation alone on health-related outcomes in individuals with non-specific low back pain: randomized controlled trial. Physiotherapy. 2020 Jun;107:71-80. doi: 10.1016/j.physio.2019.11.002. Epub 2019 Nov 18.
Results Reference
result
PubMed Identifier
33848704
Citation
Lohr C, Medina-Porqueres I. Immediate effects of myofascial release on neuromechanical characteristics in female and male patients with low back pain and healthy controls as assessed by tensiomyography. A controlled matched-pair study. Clin Biomech (Bristol, Avon). 2021 Apr;84:105351. doi: 10.1016/j.clinbiomech.2021.105351. Epub 2021 Apr 5.
Results Reference
result
PubMed Identifier
28441294
Citation
Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
Results Reference
result
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Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain
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