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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05328830
Other study ID # ETK00-2021-0070
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 4, 2022
Est. completion date April 30, 2022

Study information

Verified date June 2022
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date April 30, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Instrument assisted soft tissue mobilization
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 Roller
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.

Locations

Country Name City State
Cyprus Eastern Mediterranean University Famagusta Mersin 10, Turkey

Sponsors (1)

Lead Sponsor Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

References & Publications (23)

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. — View Citation

Beardsley C, Škarabot J. Effects of self-myofascial release: A systematic review. J Bodyw Mov Ther. 2015 Oct;19(4):747-58. doi: 10.1016/j.jbmt.2015.08.007. Epub 2015 Aug 28. Review. — View Citation

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. Review. — View Citation

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;(2):CD008262. doi: 10.1002/14651858.CD008262.pub2. — View Citation

Bradbury-Squires DJ, Noftall JC, Sullivan KM, Behm DG, Power KE, Button DC. Roller-massager application to the quadriceps and knee-joint range of motion and neuromuscular efficiency during a lunge. J Athl Train. 2015 Feb;50(2):133-40. doi: 10.4085/1062-6050-49.5.03. Epub 2014 Nov 21. — View Citation

Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. Review. — View Citation

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. Epub 2005 Sep 8. Review. — View Citation

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. — View Citation

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. — View Citation

Gajdosik RL, Bohannon RW. Clinical measurement of range of motion. Review of goniometry emphasizing reliability and validity. Phys Ther. 1987 Dec;67(12):1867-72. — View Citation

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. — View Citation

Johansson PH, Lindström L, Sundelin G, Lindström 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. — View Citation

Jönhagen S, Ackermann P, Eriksson T, Saartok T, Renström PA. Sports massage after eccentric exercise. Am J Sports Med. 2004 Sep;32(6):1499-503. Epub 2004 Jul 20. — View Citation

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. — View Citation

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. — View Citation

MacDonald GZ, Penney MD, Mullaley ME, Cuconato AL, Drake CD, Behm DG, Button DC. An acute bout of self-myofascial release increases range of motion without a subsequent decrease in muscle activation or force. J Strength Cond Res. 2013 Mar;27(3):812-21. doi: 10.1519/JSC.0b013e31825c2bc1. — View Citation

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. — View Citation

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. — View Citation

Mikesky AE, Bahamonde RE, Stanton K, Alvey T, Fitton T. Acute effects of The Stick on strength, power, and flexibility. J Strength Cond Res. 2002 Aug;16(3):446-50. — View Citation

Paschalis V, Nikolaidis MG, Theodorou AA, Giakas G, Jamurtas AZ, Koutedakis Y. Eccentric exercise affects the upper limbs more than the lower limbs in position sense and reaction angle. J Sports Sci. 2010 Jan;28(1):33-43. doi: 10.1080/02640410903334764. — View Citation

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. — View Citation

Stroiney DA, Mokris RL, Hanna GR, Ranney JD. Examination of Self-Myofascial Release vs. Instrument-Assisted Soft-Tissue Mobilization Techniques on Vertical and Horizontal Power in Recreational Athletes. J Strength Cond Res. 2020 Jan;34(1):79-88. doi: 10.1519/JSC.0000000000002628. — View Citation

Sullivan KM, Silvey DB, Button DC, Behm DG. Roller-massager application to the hamstrings increases sit-and-reach range of motion within five to ten seconds without performance impairments. Int J Sports Phys Ther. 2013 Jun;8(3):228-36. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary change between baseline of pain assessment and immidiately after DOMS created. Visual Analog Scale will be used for pain assessment. Assessments will be performed on baseline and immdidiately after DOMS created.
Primary change between baseline of pain assessment and 1 day after DOMS created. Visual Analog Scale will be used for pain assessment. Assessments will be performed on baseline and 1 day after DOMS created.
Primary change between baseline of pain assessment and 2 days after DOMS created. Visual Analog Scale will be used for pain assessment. Assessments will be performed on baseline and 2 days after DOMS created.
Primary change between baseline of pain assessment and 3 days after DOMS created. Visual Analog Scale will be used for pain assessment. Assessments will be performed on baseline and 3 days after DOMS created.
Secondary change between baseline of flexibility test and 1 day after DOMS created. sit and reach test will be used for flexility assessment Assessments will be performed on baseline and 1 day after DOMS created.
Secondary change between baseline of flexibility test and 2 days after DOMS created. sit and reach test will be used for flexility assessment Assessments will be performed on baseline and 2 days after DOMS created.
Secondary change between baseline of flexibility test and 3 days after DOMS created. sit and reach test will be used for flexility assessment Assessments will be performed on baseline and 3 days after DOMS created.
Secondary change between baseline of muscle strength test and 1 day after DOMS created. Isokinetic dynamometer will be used for muscle strength assessment Assessments will be performed on baseline and 1 day after DOMS created.
Secondary change between baseline of muscle strength test and 2 days after DOMS created. Isokinetic dynamometer will be used for muscle strength assessment Assessments will be performed on baseline and 2 days after DOMS created.
Secondary change between baseline of muscle strength test and 3 days after DOMS created. Isokinetic dynamometer will be used for muscle strength assessment Assessments will be performed on baseline and 3 days after DOMS created.
Secondary change between baseline of vertical jump test and 1 day after DOMS created. vertical jump test will be used for explosive power assessment Assessments will be performed on baseline and 1 day after DOMS created.
Secondary change between baseline of vertical jump test and 2 days after DOMS created. vertical jump test will be used for explosive power assessment Assessments will be performed on baseline and 2 days after DOMS created.
Secondary change between baseline of vertical jump test and 3 days after DOMS created. vertical jump test will be used for explosive power assessment Assessments will be performed on baseline and 3 days after DOMS created.
Secondary change between baseline of horizontal jump test and 1 day after DOMS created. horizontal jump test will be used for explosive power assessment Assessments will be performed on baseline and 1 day after DOMS created.
Secondary change between baseline of horizontal jump test and 2 days after DOMS created. horizontal jump test will be used for explosive power assessment Assessments will be performed on baseline and 2 days after DOMS created.
Secondary change between baseline of horizontal jump test and 3 days after DOMS created. horizontal jump test will be used for explosive power assessment Assessments will be performed on baseline and 3 days after DOMS created.
Secondary change between baseline of thigh circumference measurement and immediately after DOMS created. Thigh circumference measurement will be used for thigh circumference assessment Assessments will be performed on baseline and immediately after DOMS created.
Secondary change between baseline of thigh circumference measurement and 1 day after DOMS created. Thigh circumference measurement will be used for thigh circumference assessment Assessments will be performed on baseline and 1 day after DOMS created.
Secondary change between baseline of thigh circumference measurement and 2 days after DOMS created. Thigh circumference measurement will be used for thigh circumference assessment Assessments will be performed on baseline and 2 days after DOMS created.
Secondary change between baseline of thigh circumference measurement and 3 days after DOMS created. Thigh circumference measurement will be used for thigh circumference assessment Assessments will be performed on baseline and 3 days after DOMS created.
Secondary change between baseline of Y balance test and 1 day after DOMS created. Y balance test will be used for dynamic balance assessment Assessments will be performed on baseline and 1 day after DOMS created.
Secondary change between baseline of Y balance test and 2 days after DOMS created. Y balance test will be used for dynamic balance assessment Assessments will be performed on baseline and 2 days after DOMS created.
Secondary change between baseline of Y balance test and 3 days after DOMS created. Y balance test will be used for dynamic balance assessment Assessments will be performed on baseline and 3 days after DOMS created.
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