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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]

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

Trigger points

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

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]

Myometry parameter measured by Myoton device:
F- natural oscillation frequency

Timepoint [1]

Immediately after 2nd set of measurements in the participant's second visit.

Primary outcome [2]

Myometry parameter measured by Myoton device:
D- logarithmic decrement

Timepoint [2]

Immediately after 2nd set of measurements in the participant's second visit.

Primary outcome [3]

Myometry parameter measured by Myoton device:
S - dynamic stiffness

Timepoint [3]

Immediately after 2nd set of measurements in the participant's second visit.

Secondary outcome [1]

Pain catastrophizing as assessed by the Pain Catastrophising Scale.

Timepoint [1]

During the first visit.

Secondary outcome [2]

Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ).

Timepoint [2]

During the first visit.

Secondary outcome [3]

Myometry parameter measured by Myoton device:

R- mechanical stress relaxation time

PRIMARY OUTCOME

Timepoint [3]

Immediately after 2nd set of measurements in the participant's second visit.

Secondary outcome [4]

Myometry parameter measured by Myoton device:

C - ratio of deformation and relaxation time

PRIMARY OUTCOME

Timepoint [4]

Immediately after 2nd set of measurements in the participant's second visit.

Secondary outcome [5]

Participant approach to pain as assessed by the Survey of Pain Attitudes.

Timepoint [5]

During the first visit.

Secondary outcome [6]

Pressure Pain Threshold provided by pressure algometer.

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Slask

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Laboratory of Motion Analysis, Department of Physiotherapy, The Jerzy Kukuczka Academy of Physical Education in Katowice

Address [1]

Katowice, 40-007, Mikolowska 72A street, Silesia, Poland.

Country [1]

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]

Individual

Name [1]

Ewelina Bialas

Address [1]

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]

Poland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Uczelniana Komisa Bioetyczna ds. Badan Naukowych przy Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach

Ethics committee address [1]

Mikolowska 72A street, 40-065 Katowice

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

14/02/2019

Approval date [1]

11/04/2019

Ethics approval number [1]

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

Mr 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

Phone

+48791363126

Fax

przemekdebski92@gmail.com

Contact person for public queries

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

Phone

+48791363126

Fax

przemekdebski92@gmail.com

Contact person for scientific queries

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

Phone

+48791363126

Fax

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.	Type	Email	Other Details
4203	Informed consent form	przemekdebski92@gmail.com	The supporting documents can be obtained through d... [More Details]
4204	Ethical approval	przemekdebski92@gmail.com	The supporting documents can be obtained through d... [More Details]
5438	Study protocol	przemekdebski92@gmail.com	The supporting documents can be obtained through d... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		No significant changes in biomechanical parameters... [More Details]

Documents added automatically

No additional documents have been identified.

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