NCT05531851

Brief Summary

The aim of our study is to investigate the effect of instrument assisted soft tissue mobilization therapy on delayed onset muscle soreness

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 29, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

17 days

First QC Date

August 31, 2022

Last Update Submit

September 2, 2022

Conditions

Keywords

Delayed onset muscle soreness, Instrument-assisted soft tissue mobilization, recovery, eccentric exercise

Outcome Measures

Primary Outcomes (13)

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

  • 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.

    Four days

Study Arms (2)

Experiment group.

EXPERIMENTAL

İnstrument-assisted soft tissue mobilization will be applied after the delayed onset muscle soreness induction protocol

Other: Instrument Assisted Soft Tissue Mobilization

Control Group

NO INTERVENTION

Delayed onset muscle soreness generation protocol will be applied

Interventions

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.

Experiment group.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Musculoskeletal PainMyalgiaMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular DiseasesNervous System Diseases

Study Officials

  • İsmail Palalı, PhD (c)

    Harran University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İsmail Palalı, PhD (c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 8, 2022

Study Start

August 29, 2022

Primary Completion

September 15, 2022

Study Completion

September 20, 2022

Last Updated

September 8, 2022

Record last verified: 2022-09

Locations