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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.
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
Secondary ID [1] 298750 0
None
Universal Trial Number (UTN)
U1111-1237-0857
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft tissue stiffness 313683 0
Trigger points 313684 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312097 312097 0 0
Physiotherapy
Musculoskeletal 313267 313267 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 315017 0
Treatment: Devices
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
Control group
Active

Outcomes
Primary outcome [1] 320777 0
Myometry parameter measured by Myoton device:
F- natural oscillation frequency
Timepoint [1] 320777 0
Immediately after 2nd set of measurements in the participant's second visit.
Primary outcome [2] 321760 0
Myometry parameter measured by Myoton device:
D- logarithmic decrement
Timepoint [2] 321760 0
Immediately after 2nd set of measurements in the participant's second visit.
Primary outcome [3] 321761 0
Myometry parameter measured by Myoton device:
S - dynamic stiffness
Timepoint [3] 321761 0
Immediately after 2nd set of measurements in the participant's second visit.
Secondary outcome [1] 372834 0
Pain catastrophizing as assessed by the Pain Catastrophising Scale.
Timepoint [1] 372834 0
During the first visit.
Secondary outcome [2] 372835 0
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ).
Timepoint [2] 372835 0
During the first visit.
Secondary outcome [3] 376136 0
Myometry parameter measured by Myoton device:

R- mechanical stress relaxation time

PRIMARY OUTCOME
Timepoint [3] 376136 0
Immediately after 2nd set of measurements in the participant's second visit.
Secondary outcome [4] 376137 0
Myometry parameter measured by Myoton device:

C - ratio of deformation and relaxation time

PRIMARY OUTCOME
Timepoint [4] 376137 0
Immediately after 2nd set of measurements in the participant's second visit.
Secondary outcome [5] 376138 0
Participant approach to pain as assessed by the Survey of Pain Attitudes.
Timepoint [5] 376138 0
During the first visit.
Secondary outcome [6] 376139 0
Pressure Pain Threshold provided by pressure algometer.
Timepoint [6] 376139 0
Immediately after 2nd set of measurements in the participant's second visit.

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
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be developed with numbered containers.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/11/2019
Actual
30/11/2019
Date of last participant enrolment
Anticipated
31/08/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
96
Accrual to date
70
Final
Recruitment outside Australia
Country [1] 21692 0
Poland
State/province [1] 21692 0
Slask

Funding & Sponsors
Funding source category [1] 303307 0
University
Name [1] 303307 0
The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice
Country [1] 303307 0
Poland
Primary sponsor type
Individual
Name
Przemyslaw Debski
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.
Country
Poland
Secondary sponsor category [1] 303510 0
Individual
Name [1] 303510 0
Ewelina Bialas
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.
Country [1] 303510 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303841 0
Uczelniana Komisa Bioetyczna ds. Badan Naukowych przy Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach
Ethics committee address [1] 303841 0
Mikolowska 72A street, 40-065 Katowice
Ethics committee country [1] 303841 0
Poland
Date submitted for ethics approval [1] 303841 0
14/02/2019
Approval date [1] 303841 0
11/04/2019
Ethics approval number [1] 303841 0
4/2019

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94990 0
Mr Przemyslaw Debski
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.
Country 94990 0
Poland
Phone 94990 0
+48791363126
Fax 94990 0
Email 94990 0
przemekdebski92@gmail.com
Contact person for public queries
Name 94991 0
Mr Przemyslaw Debski
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.
Country 94991 0
Poland
Phone 94991 0
+48791363126
Fax 94991 0
Email 94991 0
przemekdebski92@gmail.com
Contact person for scientific queries
Name 94992 0
Mr Przemyslaw Debski
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.
Country 94992 0
Poland
Phone 94992 0
+48791363126
Fax 94992 0
Email 94992 0
przemekdebski92@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
- Statistica database with Myoton parameters for each participant after de-indentification
- Statistica protocol
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.
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator: przemekdebski92@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4203Informed consent form  przemekdebski92@gmail.com The supporting documents can be obtained through d... [More Details]
4204Ethical approval  przemekdebski92@gmail.com The supporting documents can be obtained through d... [More Details]
5438Study protocol  przemekdebski92@gmail.com The supporting documents can be obtained through d... [More Details]



Results publications and other study-related documents

Documents added manually
Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4132Plain language summaryNo No significant changes in biomechanical parameters... [More Details]

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