Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12619001615178
Ethics application status
Approved
Date submitted
20/08/2019
Date registered
22/11/2019
Date last updated
30/06/2021
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of the local and distant effects of the self-myofascial release using a foam roller on biomechanical parameters of soft tissues and Pressure Pain Threshold (PPT) in the healthy subjects.
Query!
Scientific title
Evaluation of the local and distant effects of the self-myofascial release using a foam roller on biomechanical parameters of soft tissues and Pressure Pain Threshold (PPT) in the healthy subjects
Query!
Secondary ID [1]
298750
0
None
Query!
Universal Trial Number (UTN)
U1111-1237-0857
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Soft tissue stiffness
313683
0
Query!
Trigger points
313684
0
Query!
Condition category
Condition code
Physical Medicine / Rehabilitation
312097
312097
0
0
Query!
Physiotherapy
Query!
Musculoskeletal
313267
313267
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Each participant assigned to one of the intervention groups will perform a) 30 seconds, b) 120 seconds of self-myofascial release therapy with the soft version of the foam roller. The therapy will be provided by placing the hamstrings muscle group of participants dominant lower limb (posterior thigh) on the foam roller and making repeatable movements back and forth which provide rhythmically a mechanical pressure on soft tissues.
The intervention will be provided by participants themselves after They finish short training with instruction provided by two Ph.D. students with a masters degree in physiotherapy and expertise level and experience in the field of Self Myofascial Release (SMR) with Foam Roller (FR). The training will consist of two parts. The first part will include the demonstration of the proper rolling technique made by the instructor. The second part will include the 60 seconds of FR made by a participant. During the second part, the instructor will provide additional information and correct the technique if necessary. It is described in the literature that such type of autotherapy could potentially release tension and adhesions in muscle and fascia, increase tissues blood flow and oxygenation, finish the local energetic crisis, reduce muscle pain and irritation and improve range of motion without an additional concomitant deficit in muscle strength.
The foam roller that will be used for intervention is a hard surface, 31 x 16 cm size, cert. ISO 9001:2009, ISO 14001:2005.
Arm 1 & Arm 2
The participant will meet with researches two times, face to face, in an interval of three days. On the first meeting (approximately 1 hour), participants will complete foam rolling training and get instruction on how to maintain the proper lifestyle before the intervention. On the second meeting (approximately 2 hours) participants who will be randomly assigned to one of the intervention groups, will perform SMR with FR for 30 seconds (Arm 1) and 120 seconds (Arm 2). Before and after the therapy, the investigator will carry out measurements of the participant in accordance with the protocol. The intervention will occur in Motion Analysis Laboratory, Department of physiotherapy, the University of Physical Education in Katowice, Poland.
Query!
Intervention code [1]
315017
0
Treatment: Devices
Query!
Comparator / control treatment
There will be four active control groups:
Arm 3: moving in the same manner as Arm 1 and Arm 2 groups, but without FR for 30 seconds.
Arm 4: moving in the same manner as Arm 1 and Arm 2 groups, but without FR for 120 seconds.
Arm 5: sitting straight on the floor with lower limbs extended for 30 seconds.
Arm 6: sitting straight on the floor with lower limbs extended for 120 seconds
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
320777
0
Myometry parameter measured by Myoton device:
F- natural oscillation frequency
Query!
Assessment method [1]
320777
0
Query!
Timepoint [1]
320777
0
Immediately after 2nd set of measurements in the participant's second visit.
Query!
Primary outcome [2]
321760
0
Myometry parameter measured by Myoton device:
D- logarithmic decrement
Query!
Assessment method [2]
321760
0
Query!
Timepoint [2]
321760
0
Immediately after 2nd set of measurements in the participant's second visit.
Query!
Primary outcome [3]
321761
0
Myometry parameter measured by Myoton device:
S - dynamic stiffness
Query!
Assessment method [3]
321761
0
Query!
Timepoint [3]
321761
0
Immediately after 2nd set of measurements in the participant's second visit.
Query!
Secondary outcome [1]
372834
0
Pain catastrophizing as assessed by the Pain Catastrophising Scale.
Query!
Assessment method [1]
372834
0
Query!
Timepoint [1]
372834
0
During the first visit.
Query!
Secondary outcome [2]
372835
0
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ).
Query!
Assessment method [2]
372835
0
Query!
Timepoint [2]
372835
0
During the first visit.
Query!
Secondary outcome [3]
376136
0
Myometry parameter measured by Myoton device:
R- mechanical stress relaxation time
PRIMARY OUTCOME
Query!
Assessment method [3]
376136
0
Query!
Timepoint [3]
376136
0
Immediately after 2nd set of measurements in the participant's second visit.
Query!
Secondary outcome [4]
376137
0
Myometry parameter measured by Myoton device:
C - ratio of deformation and relaxation time
PRIMARY OUTCOME
Query!
Assessment method [4]
376137
0
Query!
Timepoint [4]
376137
0
Immediately after 2nd set of measurements in the participant's second visit.
Query!
Secondary outcome [5]
376138
0
Participant approach to pain as assessed by the Survey of Pain Attitudes.
Query!
Assessment method [5]
376138
0
Query!
Timepoint [5]
376138
0
During the first visit.
Query!
Secondary outcome [6]
376139
0
Pressure Pain Threshold provided by pressure algometer.
Query!
Assessment method [6]
376139
0
Query!
Timepoint [6]
376139
0
Immediately after 2nd set of measurements in the participant's second visit.
Query!
Eligibility
Key inclusion criteria
- physically active
- tender/ irritable spots in the lower limbs muscles
- skinfold caliper test less than 35 mm
- Beighton hypermobility score less than 4/9
- Palpable iliac crest
- Sustained lifestyle before (7 days) and during researches in the matter of neuroactive substances (f.e. caffeine, nicotine) and sleep
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
35
Years
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- skinfold caliper test greater than or equal to 35 mm
- Beighton hypermobility score greater than or equal to 4/9
- Unpalpable iliac crest
- Unsustained lifestyle before (7 days) and during researches in the matter of neuroactive substances (f.e. caffeine, nicotine) and sleep
- Any thermotherapy, hydrotherapy, relaxation techniques, massages, manual therapies and any other modalities that can provide a change in soft tissue tenderness and pain perception 24 hours before the examination
- the musculoskeletal injury that required hospitalization, therapist intervention or excluded the subject from physical activity for a period longer than one week
- autoimmune diseases
- neurological disabilities
- connective tissue diseases
- current infectious disease
- osteoporosis
- scarce/ skin lesions in the area of measurements
- other diseases and factors that can possibly have an influence on soft tissues measurements
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be developed with numbered containers.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by a simple procedure: pulling paper numbers from the pool containing the full set of numbers.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
30/11/2019
Query!
Actual
30/11/2019
Query!
Date of last participant enrolment
Anticipated
31/08/2021
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2021
Query!
Actual
Query!
Sample size
Target
96
Query!
Accrual to date
70
Query!
Final
Query!
Recruitment outside Australia
Country [1]
21692
0
Poland
Query!
State/province [1]
21692
0
Slask
Query!
Funding & Sponsors
Funding source category [1]
303307
0
University
Query!
Name [1]
303307
0
The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice
Query!
Address [1]
303307
0
Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.
Query!
Country [1]
303307
0
Poland
Query!
Primary sponsor type
Individual
Query!
Name
Przemyslaw Debski
Query!
Address
The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.
Query!
Country
Poland
Query!
Secondary sponsor category [1]
303510
0
Individual
Query!
Name [1]
303510
0
Ewelina Bialas
Query!
Address [1]
303510
0
Work: The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.
Query!
Country [1]
303510
0
Poland
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
303841
0
Uczelniana Komisa Bioetyczna ds. Badan Naukowych przy Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
Query!
Ethics committee address [1]
303841
0
Mikolowska 72A street, 40-065 Katowice
Query!
Ethics committee country [1]
303841
0
Poland
Query!
Date submitted for ethics approval [1]
303841
0
14/02/2019
Query!
Approval date [1]
303841
0
11/04/2019
Query!
Ethics approval number [1]
303841
0
4/2019
Query!
Summary
Brief summary
There is no consensus on the effectiveness of SMR - FR and the mechanism that can cause improvement in various types of tests after this type of autotherapy.
Repeated measurements with high reliability using another tool (Myoton) could provide conclusive evidence of the local and distant effects of SMR autotherapy and bring closer to the answers to the questions posed in the literature. It is worth emphasizing that there is a need to objectively examine and evaluate the effects of rolling both in the contralateral limb in relation to the rolled limb and in tissues located on the same myofascial trains.
Main hypothesis:
1. The self-myofascial release procedure significantly affects the biomechanical parameters of local and global soft tissues.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
94990
0
Mr Przemyslaw Debski
Query!
Address
94990
0
The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.
Query!
Country
94990
0
Poland
Query!
Phone
94990
0
+48791363126
Query!
Fax
94990
0
Query!
Email
94990
0
[email protected]
Query!
Contact person for public queries
Name
94991
0
Mr Przemyslaw Debski
Query!
Address
94991
0
The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.
Query!
Country
94991
0
Poland
Query!
Phone
94991
0
+48791363126
Query!
Fax
94991
0
Query!
Email
94991
0
[email protected]
Query!
Contact person for scientific queries
Name
94992
0
Mr Przemyslaw Debski
Query!
Address
94992
0
The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.
Query!
Country
94992
0
Poland
Query!
Phone
94992
0
+48791363126
Query!
Fax
94992
0
Query!
Email
94992
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
- Statistica database with Myoton parameters for each participant after de-indentification
- Statistica protocol
Query!
When will data be available (start and end dates)?
Data will be available immediately after the end of the project and all related analyzes, minimum for two years and more if necessary.
Query!
Available to whom?
Researchers who provide a methodologically sound proposal
Query!
Available for what types of analyses?
Meta-analyses
Query!
How or where can data be obtained?
Access subject to approvals by Principal Investigator:
[email protected]
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4203
Informed consent form
[email protected]
The supporting documents can be obtained through d...
[
More Details
]
4204
Ethical approval
[email protected]
The supporting documents can be obtained through d...
[
More Details
]
5438
Study protocol
[email protected]
The supporting documents can be obtained through d...
[
More Details
]
Results publications and other study-related documents
Documents added manually
Current Study Results
No documents have been uploaded by study researchers.
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
4132
Plain language summary
No
No significant changes in biomechanical parameters...
[
More Details
]
Documents added automatically
No additional documents have been identified.
Download to PDF