Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness
Primary Purpose
Musculoskeletal Pain, Soreness, Muscle, Musculoskeletal Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Delayed onset muscle soreness, Instrument-assisted soft tissue mobilization, recovery, eccentric exercise
Eligibility Criteria
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
Sites / Locations
- Harran UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experiment group.
Control Group
Arm Description
İnstrument-assisted soft tissue mobilization will be applied after the delayed onset muscle soreness induction protocol
Delayed onset muscle soreness generation protocol will be applied
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
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.
Pressure-pain threshold measurement
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.
Circumference measurement
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.
Joint range of motion measurement
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
Isometric muscle strength
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.
Two-point discrimination
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.
Liver enzymes (aminotransferases)
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.
Creatine kinase
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.
Lactate dehydrogenase
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.
Myoglobin
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.
Interleukin-1 beta
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.
C reactive protein
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.
Carbonic anhydrase III
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05531851
First Posted
August 31, 2022
Last Updated
September 2, 2022
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Harran University
1. Study Identification
Unique Protocol Identification Number
NCT05531851
Brief Title
Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness
Official Title
Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Harran University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study is to investigate the effect of instrument assisted soft tissue mobilization therapy on delayed onset muscle soreness
Detailed Description
Joint range of motion, pressure pain threshold, edema, isometric muscle strength measurement, visual pain scale, two-point discrimination, biochemical measurements (muscle damage in blood (serum creatine kinase (CC), lactate dehydrogenase (LDH), myoglobin, its effects on aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and biomarkers of inflammation (interleukin-1 beta), Carbonic anhydrase III, and C-reactive protein, and at what time interval and after which treatment session in the process after delayed muscle pain formation. It is aimed to determine how it affects the parameters.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Soreness, Muscle, Musculoskeletal Disorder
Keywords
Delayed onset muscle soreness, Instrument-assisted soft tissue mobilization, recovery, eccentric exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment group.
Arm Type
Experimental
Arm Description
İnstrument-assisted soft tissue mobilization will be applied after the delayed onset muscle soreness induction protocol
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Delayed onset muscle soreness generation protocol will be applied
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Four days
Title
Pressure-pain threshold measurement
Description
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.
Time Frame
Four days
Title
Circumference measurement
Description
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.
Time Frame
Four days
Title
Joint range of motion measurement
Description
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
Time Frame
Four days
Title
Isometric muscle strength
Description
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.
Time Frame
Four days
Title
Two-point discrimination
Description
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.
Time Frame
Four days
Title
Liver enzymes (aminotransferases)
Description
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.
Time Frame
Four days
Title
Creatine kinase
Description
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.
Time Frame
Four days
Title
Lactate dehydrogenase
Description
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.
Time Frame
Four days
Title
Myoglobin
Description
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.
Time Frame
Four days
Title
Interleukin-1 beta
Description
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.
Time Frame
Four days
Title
C reactive protein
Description
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.
Time Frame
Four days
Title
Carbonic anhydrase III
Description
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.
Time Frame
Four days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İsmail Palalı, PhD (c)
Phone
5052548078
Email
ismail.palali01@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İsmail Palalı, PhD (c)
Organizational Affiliation
Harran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harran University
City
Şanlıurfa
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness
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