NCT05328830

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

January 5, 2022

Last Update Submit

June 6, 2022

Conditions

Keywords

domsmuscle strengthflexibilityrecovery

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (19)

  • change between baseline of flexibility test and 1 day after DOMS created.

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

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

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

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

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

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

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

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

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

  • +14 more secondary outcomes

Study Arms (3)

Instrument assisted soft tissue mobilization group

EXPERIMENTAL

Instrument assisted soft tissue mobilization will be applied after 30 minutes of DOMS creation

Other: Instrument assisted soft tissue mobilization

Foam roller

EXPERIMENTAL

Foam roller will be applied after 30 minutes of DOMS creation

Other: Foam Roller

control group

NO INTERVENTION

no intervention

Interventions

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.

Instrument assisted soft tissue mobilization group

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.

Foam roller

Eligibility Criteria

Age20 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, Mersin 10, Turkey, 33010, Cyprus

Location

Related Publications (23)

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    PMID: 27390432BACKGROUND
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    PMID: 26592226BACKGROUND
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    PMID: 24567849BACKGROUND
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    PMID: 25420037BACKGROUND
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    PMID: 29742744BACKGROUND
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Study Officials

  • Erdoğan Çetintaş, PT

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR
  • Berkiye Kırmızıgil, DPT

    Eastern Mediterranean University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

April 14, 2022

Study Start

January 4, 2022

Primary Completion

April 15, 2022

Study Completion

April 30, 2022

Last Updated

June 7, 2022

Record last verified: 2022-06

Locations