- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531851
Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: İsmail Palalı, PhD (c)
- Phone Number: 5052548078
- Email: ismail.palali01@gmail.com
Study Locations
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Şanlıurfa, Turkey
- Recruiting
- Harran University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The participant must be between the ages of 18-35,
- No fear of needles,
- Having read and understood the Informed Voluntary Consent Form and agreeing to participate in the study.
Exclusion Criteria:
- Having neurological or perception problems,
- Having any cardiovascular, pulmonary and metabolic disease,
- Any musculoskeletal injury in the last 6 months,
- Having a history of pain and surgery in the upper extremity,
- Participating in upper extremity weight training in the last 6 months,
- Exercise, caffeine and alcohol consumption, and drug use up to 12 hours before the study were determined as
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experiment group.
İnstrument-assisted soft tissue mobilization will be applied after the delayed onset muscle soreness induction protocol
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For IASTM treatment, IASTM soft tissue mobilization blade to apply the treatment used. It is a stainless steel shaped metal tool with beveled edges. The researcher, with a 30° angled tool, at a speed of 120 BPM, in the direction of the fibers of the m.biceps brachii muscle. He applied it with a light pressure by intervening with his weight. Researcher during treatment used a metronome to ensure consistent speed and adjusted the instrument angle before each subject's treatment. calibrated with a protractor. The application took 8 minutes and the instrument was comfortable on the skin. |
No Intervention: Control Group
Delayed onset muscle soreness generation protocol will be applied
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: Four days
|
0-100 mm Visual Analogue Scale (VAS) to assess perceived muscle pain and muscle fatigue used. Visual Analog Scale on a straight line with a value of '0' means 'no pain/fatigue', A value of '100' is a scale that indicates 'severe pain/fatigue'. The pain felt by the participants and will be asked to mark the fatigue with an x on this line, Perceived pain both during rest and evaluated during active flexion-extension movement. Perceived fatigue is just rest. evaluated while in position. |
Four days
|
Pressure-pain threshold measurement
Time Frame: Four days
|
ll measurements were evaluated using an algometer while the participants were lying in the supine position. The forearm is at 90º pronation at the side of the body and the elbow is at 0º extension. point application. reference point for measurement; three centimeters below the medial epicondyle While determining the pressure point, it was chosen as six centimeters above this reference point. measuring Before starting, a control trial was made, and the participant was asked to say "yes" as soon as they felt "discomfort" or "pain". required is specified.fatigue used. Visual Analog Scale on a straight line with a value of '0' means 'no pain/fatigue', A value of '100' is a scale that indicates 'severe pain/fatigue'. The pain felt by the participants and will be asked to mark the fatigue with an x on this line, Perceived pain both during rest and evaluated during active flexion-extension movement. Perceived fatigue is just rest. evaluated while in position. |
Four days
|
Circumference measurement
Time Frame: Four days
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Edema in the biceps brachii muscle will be evaluated by measuring the circumference Non-flexible tape measure for measurement used. The measurement was taken 3 cm above (lower arm) and 12 cm above (upper arm) elbow crease. Two measurements were made from both points and recorded by taking the average. Participant standing, relaxed The measurement was made in the position and the arm was near the body. The marked point is at the bottom line of the tape measure. measurement was carried out. |
Four days
|
Joint range of motion measurement
Time Frame: Four days
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Joint range of motion measurement will be made with a digital goniometer. loosely rested. Participants try to touch their shoulders with their palms for the EHAFLEX measurement. fully flexed the elbows, and fully extended the elbow joint for the EHAEXT measurement. tried to bring Measurements were recorded by repeating 2 times and taking the average.Non-flexible tape measure for measurement used. The measurement was taken 3 cm above (lower arm) and 12 cm above (upper arm) elbow crease. Two measurements were made from both points and recorded by taking the average. P |
Four days
|
Isometric muscle strength
Time Frame: Four days
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Isometric muscle strength of elbow flexor muscles was evaluated by hand dynamometer. Participant elbow Seated in chair with forearm supinated at 90 degrees of flexion. Flexor of the forearm by placing it on the face proximal to the styloid process and flexing the elbow of the participant for 5 seconds. direction was requested. (maximum voluntary isometric contraction) and movement A force was applied in the opposite direction by the evaluator. 3 measurements were made at 30 second intervals and recorded by taking the average. |
Four days
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Two-point discrimination
Time Frame: Four days
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In our study, this measurement was made with a disc-criminator. This tool is embedded at varying intervals each It consists of two plastic discs containing rods. The distance between the bars varies from 1mm to 25mm. The value that the subjects felt as two points was recorded. |
Four days
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Liver enzymes (aminotransferases)
Time Frame: Four days
|
The general name of these enzymes, which are specific to the liver and are frequently used to determine liver damage, are aminotransferases and consist of ALT, AST, Alkaline Phosphatase, Gamma Glutamyl Transpeptidase.
ALT and especially AST are synthesized in skeletal and cardiac muscle, Gamma Glutamyl Transpeptidase in kidneys, Alkaline Phosphatase in bones and intestinal epithelial cells.
Increases in ALT and AST levels are proportional to the level of cell damage in the body, and therefore, they are biochemical markers that are important in the progression of the damage or in the follow-up of the healing process.
In heavy exercises, increases in AST and ALT enzyme levels are observed depending on the duration and intensity of the exercise.
|
Four days
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Creatine kinase
Time Frame: Four days
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Serum CC is the intramuscular enzyme responsible for keeping ATP at the appropriate level during muscle contraction.
In addition, it is the most valid protein that increases after exercise as the most important marker of muscle damage.
An increase in the serum CC level indicates that the membrane surrounding the muscle cell is ruptured or its permeability is increased.
The peak time of serum CC, which increases after exercise, varies depending on the type, intensity and duration of exercise.
In general, it was stated that serum CC level started to rise after exercise, reached its highest level after 24 hours and continued for 48 hours.
|
Four days
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Lactate dehydrogenase
Time Frame: Four days
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Another enzyme used to assess muscle damage is lactate dehydrogenase (LDH), which catalyzes the conversion of pyruvate to lactate in anaerobic glycolysis.
In muscle damage after exercise, serum LDH level reaches its highest value in the first 6 hours and returns to its pre-exercise basal level 24-72 hours later.
|
Four days
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Myoglobin
Time Frame: Four days
|
It is a low-molecule protein found in heart and skeletal muscle and provides storage of oxygen and transport to mitochondria in the muscle cell.
There are three different isoforms of myoglobin in skeletal muscle, and its secretion increases as a result of the deterioration of protein structures due to muscle damage after heavy exercises.
After muscle damage, myoglobin level increases within 2 hours, reaches its highest value in 6-9 hours and returns to normal in 24-36 hours.
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Four days
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Interleukin-1 beta
Time Frame: Four days
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It is a low-molecule protein found in heart and skeletal muscle and provides storage of oxygen and transport to mitochondria in the muscle cell.
There are three different isoforms of myoglobin in skeletal muscle, and its secretion increases as a result of the deterioration of protein structures due to muscle damage after heavy exercises.
After muscle damage, myoglobin level increases within 2 hours, reaches its highest value in 6-9 hours and returns to normal in 24-36 hours.
|
Four days
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C reactive protein
Time Frame: Four days
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CRP is another generally accepted marker of inflammation and is synthesized by the liver in response to high plasma levels of IL-6 in the body.
CRP level is significantly increased in acute myocardial infarction, stress, trauma, infection, inflammation, post-surgery or neoplastic proliferation.
The increase in CRP in muscle damage and inflammation that occurs after exercise begins within 6-8 hours and reaches its peak levels within 24-48 hours.
However, studies give conflicting information about whether the CRP level will increase with exercise.
These results suggest that more research is needed to fully understand the effects of plasma CRP response after vigorous exercise.
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Four days
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Carbonic anhydrase III
Time Frame: Four days
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Carbonic anhydrase III (CAIII) is a member of a multigene family (at least six separate genes are known) that encode carbonic anhydrase isozymes.
These carbonic anhydrases are a class of metalloenzymes that catalyze the reversible hydration of carbon dioxide and are differentially expressed in a number of cell types.
|
Four days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: İsmail Palalı, PhD (c), Harran University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- SaglikBilimleriU-63
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
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