Fascia manipulation for the treatment of muscle pain
| ISRCTN | ISRCTN13533739 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13533739 |
| Secondary identifying numbers | (1/2017) |
- Submission date
- 11/12/2019
- Registration date
- 15/01/2020
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
The Jerzy Kukuczka Academy of Physical Education in Katowice
Mikołowska 72B
Katowice
40-065
Poland
 ORCID ID |
0000-0003-0890-7718 |
|---|---|
| Phone | +48 508852486 |
| m.pawlukiewicz@awf.katowice.pl |
Study information
| Study design | Double-blinded randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | Standard treatment protocol of Fascial Manipulation method has better effects than modified protocols or controls |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 10/01/2017 |
| Completion date | 31/07/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 54 |
| Key inclusion criteria | 1. Age 18-40 2. Presence of musculoskeletal pain for at least 1 week or healthy with no pain (for control group) |
| Key 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 |
| Date of first enrolment | 15/01/2020 |
| Date of final enrolment | 20/04/2021 |
Locations
Countries of recruitment
- Poland
Study participating centre
Katowice
40-065
Poland
Sponsor information
University/education
Mikołowska 72A
Katowice
40-065
Poland
| Phone | +48 32 207 51 10 |
|---|---|
| rektorat@awf.katowice.pl | |
| Website | https://www.awf.katowice.pl/ |
"ROR" |
https://ror.org/05wtrdx73 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 30/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/08/2022 | 27/02/2023 | Yes | No |
Editorial Notes
27/02/2023: Publication reference and total final enrolment added.
17/12/2019: Trial’s existence confirmed by The Jerzy Kukuczka Academy of Physical Education Ethics Committee
