AzTrials
AzTrials

Musculoskeletal PainNCT05531851

Effects of Instrument Assisted Soft Tissue Mobilization on Delayed Onset Muscle Soreness

A study testing Instrument Assisted Soft Tissue Mobilization in people with Musculoskeletal Pain and Soreness, Muscle, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
What is being tested?
Instrument Assisted Soft Tissue Mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Aug 2022to 20 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

İsmail Palalı, PhD (c) contact

5052548078

ismail.palali01@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Harran University

    Sanliurfa

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Being tested
Instrument Assisted Soft Tissue Mobilization
Keywords
Delayed onset muscle soreness, Instrument-assisted soft tissue mobilization, recovery, eccentric exercise
Medical subject headings
Musculoskeletal Pain, Myalgia, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instrument Assisted Soft Tissue MobilizationOther

    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.

Study groups in NCT05531851
Study groupRoleWhat they receive
Experiment group.Experimentalİnstrument-assisted soft tissue mobilization will be applied after the delayed onset muscle soreness induction protocol
Receives: Other: Instrument Assisted Soft Tissue Mobilization
Control GroupNo interventionDelayed onset muscle soreness generation protocol will be applied

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Four days

  2. 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.

    Measured: Four days

  3. 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.

    Measured: Four days

  4. 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

    Measured: Four days

  5. 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.

    Measured: Four days

  6. 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.

    Measured: Four days

  7. 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.

    Measured: Four days

  8. 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.

    Measured: Four days

  9. 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.

    Measured: Four days

  10. 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.

    Measured: Four days

  11. 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.

    Measured: Four days

  12. 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.

    Measured: Four days

  13. 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.

    Measured: Four days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start29 Aug 2022
  3. Primary completion15 Sep 2022 (estimated)
  4. Study completion20 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531851
Sponsor's protocol ID
SaglikBilimleriU-63
Status last verified
Sep 2022
First submitted
31 Aug 2022
Last updated
8 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Instrument Assisted Soft Tissue Mobilization in people with Musculoskeletal Pain and Soreness, Muscle, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact İsmail Palalı, PhD (c) (5052548078, ismail.palali01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) (time frame: Four days). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in