Investigating the Effects of Different Soft Tissue Mobilizations on Delayed Onset Muscle Soreness

March 13, 2023 updated by: Umut Ziya Kocak, Izmir Katip Celebi University

Investigating the Effects of Different Soft Tissue Mobilizations on Delayed Onset Muscle Soreness and Performance in Recreational Athletes: A Single Blinded, Randomized Controlled Study

Delayed onset muscle soreness (DOMS) is associated with the initiation of a new physical activity or a sudden increase in exercise volume and intensity. DOMS also occurs following eccentric exercises such as ballistic stretching, downhill running, weight training and plyometrics. DOMS might prevent performing sports and decreases the performance of professional or recreational athletes. Recently, different soft tissue mobilization applications (massage, foam roller) have been preferred by many athletes to prevent DOMS. However, there is no study comparing the effects of these techniques on DOMS. Therefore, the aim of the present study is to investigate the effects of different soft tissue mobilization practices on DOMS and sportive performance in recreational athletes. In order to achieve this goal, a total of 36 recreational athletes will be included and will be allocated to three groups as foam roller group (n=12), massage group (n=12) and control group (n=12). Demographic data, thermal camera measurements, fatigue level assessments, and performance measurements will be performed. All measurements will be carried out four times as before the application, immediately after the application, after 24 hours and after 48 hours.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being invited to the study, the demographic data of all participants who agreed to participate in the study will be recorded on a structured form. Participants will be randomly divided into three groups: Massage application group, Foam Roller application group and Control group. Afterwards, thermal imaging, perceived fatigue and pain level, blood lactate level measurements, and vertical jump assessments will be done for the quadriceps femoris muscle. Then, the fatigue protocol will be applied for the quadriceps femoris muscle and five-minute applications will be made according to the groups in which they are randomly separated. Evaluations made in the first applications will be made immediately after the applications, 24 hours and 48 hours later, as the 2nd, 3rd and 4th measurements. The assessor will not know which group the participants are from.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • İzmir, Turkey, 35330
        • Izmir Katip Celebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Performing recreational sports at least 1 and at most 3 times a week.

Exclusion Criteria:

  • Any musculoskeletal, neurological or other serious health problems experienced in the past six months
  • Not willing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Foam roller group
Participants will perform a 100 fall-bounces (5 sets x 20 reps, with two minutes of rest) from a 50 cm high box as the fatigue protocol. All participants will use a five-minute bicycle ergometer to warm up prior to the. Following the fatigue protocol, foam roler will be applied to the participants' quadriceps femoris muscles in a prone position for five minutes.
Other: Foam roller application
Following the fatigue protocol, foam roller application will be applied to the quadriceps femoris muscle for five minutes in the prone position.
Experimental: Massage group
Participants will perform a 100 fall-bounces (5 sets x 20 reps, with two minutes of rest) from a 50 cm high box as the fatigue protocol. All participants will use a five-minute bicycle ergometer to warm up prior to the. Following the fatigue protocol, sports massage will be applied on the quadriceps femoris muscles for five minutes.
Other: Massage application
Following the fatigue protocol, sports massage will be applied to the quadriceps femoris muscle for five minutes.
No Intervention: Control group
Participants will perform a 100 fall-bounces (5 sets x 20 reps, with two minutes of rest) from a 50 cm high box as the fatigue protocol. All participants will use a five-minute bicycle ergometer to warm up prior to the. Following the fatigue protocol, the participants will rest in the long sitting position for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tissue Temperature Change
Time Frame: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Tissue temperature change will be assessed by using thermal camera imaging which is a non-invasive method. By determining the temperature differences in the tissues with the thermal camera, it will be determined in which regions the circulation increases or decreases.
Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Blood Lactate Level Change
Time Frame: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Lactate Edge will be used and the lactate levels will be measured from a drop of blood.
Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Fatigue and Pain Level Changes
Time Frame: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
By using a 0-100 millimeter visual analog scale (0: none, 100: maximum), the participants will determine the fatigue and pain levels. Higher scores indicate worse fatigue and pain.
Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Change in Lower Extremity Anaerobic Performance
Time Frame: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Vertical jump test will be used to evaluate the lower extremity anaerobic performance.
Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Katip Celebi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-KAE-0372

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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