Muscle SorenessNCT04248764
Investigating the Effects of Different Soft Tissue Mobilizations on Delayed Onset Muscle Soreness
A study testing Foam roller application and Massage application in people with Muscle Soreness, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Foam roller application and Massage application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2021to 14 Mar 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Performing recreational sports at least 1 and at most 3 times a week.
Who cannot join
- Any musculoskeletal, neurological or other serious health problems experienced in the past six months
- Not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Soreness
- Being tested
- Foam roller application, Massage application
- Keywords
- Recreational athlete, Soft Tissue Mobilization, Delayed Onset Muscle Soreness
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam roller applicationOther
Following the fatigue protocol, foam roller application will be applied to the quadriceps femoris muscle for five minutes in the prone position.
Massage applicationOther
Following the fatigue protocol, sports massage will be applied to the quadriceps femoris muscle for five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Foam roller group | Experimental | 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. Receives: Other: Foam roller application |
| Massage group | Experimental | 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. Receives: Other: Massage application |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Tissue Temperature Change
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.
Measured: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Blood Lactate Level Change
Lactate Edge will be used and the lactate levels will be measured from a drop of blood.
Measured: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Secondary outcomes (2)
Perceived Fatigue and Pain Level Changes
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.
Measured: 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
Vertical jump test will be used to evaluate the lower extremity anaerobic performance.
Measured: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start10 Feb 2021
- Primary completion30 Jan 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Ziya Kocak, Izmir Katip Celebi University
- Investigators
- Umut Ziya Kocak, Study director, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248764
- Sponsor's protocol ID
- 2019-KAE-0372
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Different Soft Tissue Mobilizations on Delayed Onset Muscle Soreness and Performance in Recreational Athletes: A Single Blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04248764
- Acronym / sponsor ID
- 2019-KAE-0372
- Conditions
- Muscle Soreness
- Keywords
- Recreational athlete, Soft Tissue Mobilization, Delayed Onset Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foam roller group | Experimental | Other: Foam roller applicationParticipants 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. |
| Massage group | Experimental | Other: Massage applicationParticipants 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Performing recreational sports at least 1 and at most 3 times a week.
Key exclusion criteria (2 listed)
- Any musculoskeletal, neurological or other serious health problems experienced in the past six months
- Not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foam roller applicationFollowing the fatigue protocol, foam roller application will be applied to the quadriceps femoris muscle for five minutes in the prone position. | Other | Foam roller group |
| Massage applicationFollowing the fatigue protocol, sports massage will be applied to the quadriceps femoris muscle for five minutes. | Other | Massage group |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Ziya Kocak study director
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foam roller application and Massage application in people with Muscle Soreness, run by Izmir Katip Celebi University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 14 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue Temperature Change (time frame: Four measurements will be performed as immediately before, immediately after, 24 hours and 48 hours later from fatigue protocol.). The study lists 2 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 14 Mar 2023.