- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05302882
Evaluation of The Immediate Effect of Myofascial Release Application in Patients With Chronic Low Back Pain
Evaluation of The Immediate Effect of Myofascial Release Application on Pain, Flexibility and Trunk Mobility in Patients With Chronic Low Back Pain
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".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eyupsultan
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Istanbul, Eyupsultan, Turkey, 2022
- Halic University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
Myofascial release was applied to the experimental group
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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.
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Active Comparator: Control Group
Classical massage was applied to the control group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Pain Score
Time Frame: Baseline, immediately after the intervention
|
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
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Baseline, immediately after the intervention
|
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Change in The Straight Leg Raise Test Score
Time Frame: Baseline, immediately after the intervention
|
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.
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Baseline, immediately after the intervention
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Change in The Modified Schober Test Score
Time Frame: Baseline, immediately after the intervention
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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.
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Baseline, immediately after the intervention
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Change in Sit and Reach Test Score
Time Frame: Baseline, immediately after the intervention
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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
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Baseline, immediately after the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- acetinkaya
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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