Plain English Summary
Background and study aims
Muscle pain (myofascial pain) is a clear problem whose source is not fully understood. It may be a consequence of wrong fascial tension. It is assumed that restoration of the right fascial tension using manual methods, including deep massage (Fascia Manipulation [FM]), can reduce the patient's pain sensation.
Who can participate?
People of 18-40 years old of all genders with musculoskeletal pain for at least 1 week or healthy people for the control group
What does the study involve?
Participants will be randomly allocated to one of three therapies of Fascial Manipulation (different methods in different groups) or no treatment at all (control group).
What are the possible benefits and risks of participating?
Possible benefits: Reduction in myofascial pain and improvement in quality of life.
Risks: local pain caused by deep friction massage.
Where is the study run from?
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland
When is the study starting and how long is it expected to run for?
January 2020 to July 2021
Who is funding the study?
The Jerzy Kukuczka Academy of Physical Education in Katowice, Poland
Who is the main contact?
Mateusz Pawlukiewicz
m.pawlukiewicz@awf.katowice.pl
Trial website
Contact information
Type
Public
Primary contact
Mr Mateusz Pawlukiewicz
ORCID ID
http://orcid.org/0000-0003-0890-7718
Contact details
The Jerzy Kukuczka Academy of Physical Education in Katowice
Mikołowska 72B
Katowice
40-065
Poland
+48 508852486
m.pawlukiewicz@awf.katowice.pl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
(1/2017)
Study information
Scientific title
Evaluation of Fascial Manipulation method on effectiveness in treatment of myofascial pain: a randomised controlled trial of various treatment protocols and their influence on pain levels, the reactivity of soft tissues, change in USG imaging (including elastography), EMG, range of motion, function, and Neurac's tests
Acronym
Study hypothesis
Standard treatment protocol of Fascial Manipulation method has better effects than modified protocols or controls
Ethics approval
Approved DATE, The Jerzy Kukuczka Academy of Physical Education Ethics Committee (Uczelniana Komisja Bioetyczna AWF Katowice, ul. Mikołowska 72a, 40-065 Katowice, Poland; +48 322075152; a.smykla@awf.katowice.pl) ref: (1/2017)
Study design
Double-blinded randomized control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Myofascial pain
Intervention
Patients will be randomly allocated (using a computer program) to one of three groups, where each group will have a different therapy protocol and there will be a control group with no therapy as well. Each protocol will involve three treatments at intervals of 7-10 days, and a follow-up examination after 30 days. Study will be single-centre, and will take place at the premises of The Jerzy Kukuczka Academy of Physical Education.
Patients in treatments groups will undergo a Fascial Manipulation therapy (with different protocols), while the control group will not have any treatment. Patients will be randomly allocated to each group, using a computer program. Each protocol group will involve three treatments at intervals of 7-10 days, and a follow-up examination after 30 days.
Group 1: fascial manipulations according to the Stecco’s concept (manipulation of 2 most densified myofascial trains, that stand in opposition to each other)
Group 2: fascial manipulations according to modified Stecco’s protocol (manipulation of 2 myofascial trains, that stand in opposition to each other, but not that much densified as points of first group)
Group 3: fascial manipulations of random Stecco’s centers of coordination
Control group: no treatment was provided
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measured before and after first therapy, after third therapy and after 30 days (follow-up):
1. Pain levels - VAS scale
2. Reactivity of soft tissues - MyotonPro device
Secondary outcome measures
Measured before and after first therapy, after third therapy and after 30 days (follow-up):
1. Change in USG imaging (including elastography) (USG Device)
2. EMG (EMG device)
3. Range of motion (digital inclinometer)
4. Function (FMS)
5. Proprioception (kinesthesia tests)
6. Neuromuscular activation test using Neurac test protocol.
Overall trial start date
10/01/2017
Overall trial end date
31/07/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-40
2. Presence of musculoskeletal pain for at least 1 week or healthy with no pain (for control group)
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Coexistence of a chronic or systemic disease
2. Pregnancy
3. Taking steroids, anti-inflammatory drugs or drugs that change blood coagulability
4. Acute injuries
5. Acute surgical interventions
6. The use of other therapeutic forms
7. Serious neurological disorders
Recruitment start date
15/01/2020
Recruitment end date
20/04/2021
Locations
Countries of recruitment
Poland
Trial participating centre
The Jerzy Kukuczka Academy of Physical Education
Mikołowska 72A
Katowice
40-065
Poland
Sponsor information
Organisation
The Jerzy Kukuczka Academy of Physical Education
Sponsor details
Mikołowska 72A
Katowice
40-065
Poland
+48 32 207 51 10
rektorat@awf.katowice.pl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The Jerzy Kukuczka Academy of Physical Education in Katowice
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to ethics restriction on sharing data.
Intention to publish date
30/09/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list