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PerformanceNCT05328830

Soft Tissue Mobilization Effects on Doms

A study testing Instrument assisted soft tissue mobilization and Foam Roller in people with Performance, run by Eastern Mediterranean University at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Aim: The aim of the study was to examine and compare the time-dependent effects of IASTM and FR applications on delayed muscle pain and physical performance. Method: 50 physically active healthy male individuals between the ages of 20-35 will be included in the study. Read more about this study

Who is it for?
Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Performance
What is being tested?
Instrument assisted soft tissue mobilization and Foam Roller
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCyprus
Study dates
4 Jan 2022to 30 Apr 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 20 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Recreationally active (who do moderate-vigorous physical activity at least 2 times a week)
  • Those who are moderately and/or highly active according to the IPAQ scale
  • Between the ages of 20-35
  • Doing moderate to severe physical activity at least 2 times a week
  • Those who have not received IASTM or Foam Roller application in the last 30 days

Who cannot join

  • Those who are allergic to the intermediate used material in IASTM application
  • Those who use alcohol and supplements
  • Those who have any lower extremity injury in the last 6 months
  • Those with orthopedic or neurological disease

Trial locations and contacts

1 site in 1 country.

Cyprus1 site
  • Eastern Mediterranean University

    Famagusta, Mersin 10, Turkey, 33010

Other trials in Cyprus

About this study

Official title: Comparison of the Effects of Instrumental Assisted Soft Tissue Mobilization and Foam Roller on Delayed Muscle Pain.

Aim: The aim of the study was to examine and compare the time-dependent effects of IASTM and FR applications on delayed muscle pain and physical performance.

Method: 50 physically active healthy male individuals between the ages of 20-35 will be included in the study. Participants will be divided into 3 separate groups as instrument assisted soft tissue mobilization(IASTM), foam roller (FR) and control group. DOMS creation protocol will be implemented after preliminary evaluation. IASTM and FR groups will be treated after the formation of doms. The control group will not be applied. participants are evaluated 1 day before the doms were created and at 24, 48 and 72 hours after doms created. Subjetcs were tested for physical activity level with IPAQ-SF, flexibility with sit and reach test, pain with Visual analog scale, edema with thigh circumference measurement, explosive power with horizontal and vertical jump test, dynamic balance with y balance test and isokinetic muscle strength of the quadriceps and hamstring muscles with isokinetic dynamometer.

Read the detailed description

Muscle soreness after exercise is often referred to as delayed onset muscle soreness (DOMS). DOMS is common in people who do strenuous and unusual exercise and physical activity. DOMS, also called Grade 1 muscle strain, is characterized by localized tenderness and pain. DOMS typically peaks between 24-72 hours after strenuous exercise and disappears within 5-7 days.2-4 Associated with exercises involving eccentric muscle movement DOMS also affects athletic performance by causing decreased range of motion and reduced peak torque.

According to literature, many improvement strategies have been used by athletes, coaches and health professionals to minimize DOMS symptoms and improve performance. These strategies include massage, stretching exercises and the use of anti-inflammatory drugs. Studies conducted in different populations to date show that the results of these treatments on DOMS usually have minimal analgesic effects. Improvements in strength and flexibility have also been observed in some studies.

Myofascial release method, developed by James Cyriax, Instrument assisted soft tissue mobilization (IASTM) is applied with specially designed instruments. In particular, the use of instruments in the technique, which has been shown to have a mobilizing effect on soft tissue to reduce pain, increase range of motion and function, creates a deeper effect and allows specific treatment. It is also known to provide a mechanical advantage for the clinician by reducing the pressure on the hand. Current studies show that IASTM can improve joint ROM change the perception of pain and increase local circulation

Foam Roller (FR), another method used for myofascial relaxation, is a method that has been frequently researched in recent years, especially in the warming and recovery phases. FR includes a wide variety of therapy techniques, including massage and self-massage. Myofascial release is used to treat somatic dysfunction causing pain and limitation. Self myofascial release is performed using FR or stick. To demonstrate the effect of self-myofascial relaxation, studies focused on the effect of FR on increasing ROM, reducing muscle soreness, and lower extremity biomechanical performance. The first effect is associated with recovery and recovery, while the second effect is associated with performance. There are several studies reporting that FR also has a major impact on improving flexibility. In fact, there are studies reporting that it shows this effect even after a single FR session.

The number of studies investigating or comparing the effects of FR and IASTM techniques on delayed muscle pain is very limited in the literature. Studies comparing the effects of the two techniques have generally compared their effectiveness in the upper extremity muscles. In the lower extremity, there is only one study investigating and comparing the effects of both treatment methods in healthy active individuals. In this study, only the effects of techniques on flexibility were evaluated. Therefore, the aim of our study is to examine and compare the time-dependent effects of IASTM and FR applications on delayed muscle pain and physical performance.

Method:

Participants who want to take part in the study will first be informed about the study in written and verbal form and their written consent will be obtained. Then, the socio-demographic characteristics and information of all participants will be recorded. On the same day, the assessments detailed below will be audited by all participants and they will be given the opportunity to practice in order to adapt to the assessment methods. Preliminary evaluations of all participants (all evaluations mentioned in the evaluations section) will be taken at least 48 hours after the practice day. After the preliminary evaluations, individuals will be randomly divided into 3 groups with GraphPad - version 8.4.3 software in order to determine which group (foam roller/instrument assisted soft tissue mobilization or control group) the participants will be in. Treatment methods to be applied to the groups were divided into two as IASTM and Foam roller.

Group 1 (Foam Roller): It will be applied to the Quadriceps, Hamstring and Gastrocnemius muscles of the participant's dominant lower extremity using a rigid FR. A total of 6 minutes will be applied to a person, 2 minutes for each muscle. Pressure intensity; According to the Visual Analogue Scale, which is the point where pain will not be felt but moderate to severe discomfort will be felt, it will be done at a severity of 7/10.

Group 2 (IASTM): Myofascial release technique will be applied to the Quadriceps, Hamstring and Gastrocnemius muscles in the dominant lower extremity of the participant with the Graston technique®, the instrument to be used in this technique. The application will be at 45° angles for each muscle, 2 minutes, for a total of 6 minutes. The IASTM application will include sweep-fan-sweep strokes and cycles will be performed along each muscle for a specified time.

Group 3 (control): Individuals in this group will be asked not to participate in any physical activity during the evaluations (5 days) and to do their normal daily activities

Method: After the first evaluations, DOMS will be applied 48 hours later. Immediately after the DOMS is created, FR will be applied to those in Group 1, IASTM will be applied to those in Group 2, and no application will be made to those in Group 3. On the same day, 30 minutes after the applications, pain (VAS) and edema (Quadriceps circumference measurement) will be evaluated. At 24, 48 and 72 hours, all evaluations will be repeated to the participants.

DOMS creation protocol: It will be created by eccentric contraction in the isokinetic device. The patient will be positioned with the knee at 90° flexion. Then, the knee extensors will be asked to perform 5 sets of 15 repetitions of maximal voluntary eccentric contraction at an angular speed of 60°/s. There will be 2 minutes of rest between sets.

Conditions
Performance
Being tested
Instrument assisted soft tissue mobilization, Foam Roller
Keywords
doms, muscle strength, flexibility, recovery

What participants receive

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

  • Instrument assisted soft tissue mobilizationOther

    Myofascial release technique will be applied to the Quadriceps, Hamstring and Gastrocnemius muscles of the participant's dominant lower extremity with the Graston technique®. The application will be at 450 angles for each muscle, 2 minutes, for a total of 6 minutes. The IASTM application will include sweep-fan-sweep strokes and cycle through each muscle for the specified time.

  • Foam RollerOther

    Will be applied to the Quadriceps, Hamstring and Gastrocnemius muscles of the participant's dominant lower extremity using rigid Foam Roller. A total of 6 minutes will be applied to a person, 2 minutes for each muscle. Pressure intensity; According to the Visual Analog Scale, which is the point where pain will not be felt but moderate to severe discomfort will be felt, it will be done at a severity of 7/10.

Study groups in NCT05328830
Study groupRoleWhat they receive
Instrument assisted soft tissue mobilization groupExperimentalInstrument assisted soft tissue mobilization will be applied after 30 minutes of DOMS creation
Receives: Other: Instrument assisted soft tissue mobilization
Foam rollerExperimentalFoam roller will be applied after 30 minutes of DOMS creation
Receives: Other: Foam Roller
control groupNo interventionno intervention

What is being measured

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

  1. change between baseline of pain assessment and immidiately after DOMS created.

    Visual Analog Scale will be used for pain assessment.

    Measured: Assessments will be performed on baseline and immdidiately after DOMS created.

  2. change between baseline of pain assessment and 1 day after DOMS created.

    Visual Analog Scale will be used for pain assessment.

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  3. change between baseline of pain assessment and 2 days after DOMS created.

    Visual Analog Scale will be used for pain assessment.

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  4. change between baseline of pain assessment and 3 days after DOMS created.

    Visual Analog Scale will be used for pain assessment.

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

Secondary outcomes (19)
  1. change between baseline of flexibility test and 1 day after DOMS created.

    sit and reach test will be used for flexility assessment

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  2. change between baseline of flexibility test and 2 days after DOMS created.

    sit and reach test will be used for flexility assessment

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  3. change between baseline of flexibility test and 3 days after DOMS created.

    sit and reach test will be used for flexility assessment

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

  4. change between baseline of muscle strength test and 1 day after DOMS created.

    Isokinetic dynamometer will be used for muscle strength assessment

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  5. change between baseline of muscle strength test and 2 days after DOMS created.

    Isokinetic dynamometer will be used for muscle strength assessment

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  6. change between baseline of muscle strength test and 3 days after DOMS created.

    Isokinetic dynamometer will be used for muscle strength assessment

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

  7. change between baseline of vertical jump test and 1 day after DOMS created.

    vertical jump test will be used for explosive power assessment

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  8. change between baseline of vertical jump test and 2 days after DOMS created.

    vertical jump test will be used for explosive power assessment

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  9. change between baseline of vertical jump test and 3 days after DOMS created.

    vertical jump test will be used for explosive power assessment

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

  10. change between baseline of horizontal jump test and 1 day after DOMS created.

    horizontal jump test will be used for explosive power assessment

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  11. change between baseline of horizontal jump test and 2 days after DOMS created.

    horizontal jump test will be used for explosive power assessment

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  12. change between baseline of horizontal jump test and 3 days after DOMS created.

    horizontal jump test will be used for explosive power assessment

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

  13. change between baseline of thigh circumference measurement and immediately after DOMS created.

    Thigh circumference measurement will be used for thigh circumference assessment

    Measured: Assessments will be performed on baseline and immediately after DOMS created.

  14. change between baseline of thigh circumference measurement and 1 day after DOMS created.

    Thigh circumference measurement will be used for thigh circumference assessment

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  15. change between baseline of thigh circumference measurement and 2 days after DOMS created.

    Thigh circumference measurement will be used for thigh circumference assessment

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  16. change between baseline of thigh circumference measurement and 3 days after DOMS created.

    Thigh circumference measurement will be used for thigh circumference assessment

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

  17. change between baseline of Y balance test and 1 day after DOMS created.

    Y balance test will be used for dynamic balance assessment

    Measured: Assessments will be performed on baseline and 1 day after DOMS created.

  18. change between baseline of Y balance test and 2 days after DOMS created.

    Y balance test will be used for dynamic balance assessment

    Measured: Assessments will be performed on baseline and 2 days after DOMS created.

  19. change between baseline of Y balance test and 3 days after DOMS created.

    Y balance test will be used for dynamic balance assessment

    Measured: Assessments will be performed on baseline and 3 days after DOMS created.

Timeline

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

  1. First posted14 Apr 2022
  2. Study start4 Jan 2022
  3. Primary completion15 Apr 2022
  4. Study completion30 Apr 2022

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05328830
Sponsor's protocol ID
ETK00-2021-0070
Status last verified
Jun 2022
First submitted
5 Jan 2022
Last updated
7 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.

    PubMed 12617692
  • Close GL, Ashton T, McArdle A, Maclaren DP. The emerging role of free radicals in delayed onset muscle soreness and contraction-induced muscle injury. Comp Biochem Physiol A Mol Integr Physiol. 2005 Nov;142(3):257-66. doi: 10.1016/j.cbpa.2005.08.005. Epub 2005 Sep 8.

    PubMed 16153865
  • Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.

    PubMed 22336838
  • Bieuzen F, Bleakley CM, Costello JT. Contrast water therapy and exercise induced muscle damage: a systematic review and meta-analysis. PLoS One. 2013 Apr 23;8(4):e62356. doi: 10.1371/journal.pone.0062356. Print 2013.

    PubMed 23626806
  • Costello JT, Bieuzen F, Bleakley CM. Where are all the female participants in Sports and Exercise Medicine research? Eur J Sport Sci. 2014;14(8):847-51. doi: 10.1080/17461391.2014.911354. Epub 2014 Apr 25.

    PubMed 24766579
  • Jonhagen S, Ackermann P, Eriksson T, Saartok T, Renstrom PA. Sports massage after eccentric exercise. Am J Sports Med. 2004 Sep;32(6):1499-503. doi: 10.1177/0363546503262196. Epub 2004 Jul 20.

    PubMed 15310577
  • Johansson PH, Lindstrom L, Sundelin G, Lindstrom B. The effects of preexercise stretching on muscular soreness, tenderness and force loss following heavy eccentric exercise. Scand J Med Sci Sports. 1999 Aug;9(4):219-25. doi: 10.1111/j.1600-0838.1999.tb00237.x.

    PubMed 10407930
  • Donnelly AE, Maughan RJ, Whiting PH. Effects of ibuprofen on exercise-induced muscle soreness and indices of muscle damage. Br J Sports Med. 1990 Sep;24(3):191-5. doi: 10.1136/bjsm.24.3.191.

    PubMed 2078806
  • Baker RT, Hansberger BL, Warren L, Nasypany A. A NOVEL APPROACH FOR THE REVERSAL OF CHRONIC APPARENT HAMSTRING TIGHTNESS: A CASE REPORT. Int J Sports Phys Ther. 2015 Oct;10(5):723-33.

    PubMed 26491622
  • MacDonald N, Baker R, Cheatham SW. THE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION ON LOWER EXTREMITY MUSCLE PERFORMANCE: A RANDOMIZED CONTROLLED TRIAL. Int J Sports Phys Ther. 2016 Dec;11(7):1040-1047.

    PubMed 27999718
  • Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3.

    PubMed 19083680
  • Lee JH, Lee DK, Oh JS. The effect of Graston technique on the pain and range of motion in patients with chronic low back pain. J Phys Ther Sci. 2016 Jun;28(6):1852-5. doi: 10.1589/jpts.28.1852. Epub 2016 Jun 28.

    PubMed 27390432
  • Markovic G. Acute effects of instrument assisted soft tissue mobilization vs. foam rolling on knee and hip range of motion in soccer players. J Bodyw Mov Ther. 2015 Oct;19(4):690-6. doi: 10.1016/j.jbmt.2015.04.010. Epub 2015 May 5.

    PubMed 26592226
  • Laudner K, Compton BD, McLoda TA, Walters CM. Acute effects of instrument assisted soft tissue mobilization for improving posterior shoulder range of motion in collegiate baseball players. Int J Sports Phys Ther. 2014 Feb;9(1):1-7.

    PubMed 24567849
  • Portillo-Soto A, Eberman LE, Demchak TJ, Peebles C. Comparison of blood flow changes with soft tissue mobilization and massage therapy. J Altern Complement Med. 2014 Dec;20(12):932-6. doi: 10.1089/acm.2014.0160.

    PubMed 25420037

Questions about this trial

What is this clinical trial studying?

A study testing Instrument assisted soft tissue mobilization and Foam Roller in people with Performance, run by Eastern Mediterranean University at 1 site in Cyprus.

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 5 inclusion and 4 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 7 Jun 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 Cyprus. 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?

change between baseline of pain assessment and immidiately after DOMS created. (time frame: Assessments will be performed on baseline and immdidiately after DOMS created.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05328830, which also lists 23 linked publications.

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 7 Jun 2022.

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