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Trial registered on ANZCTR


Registration number
ACTRN12622000010796
Ethics application status
Approved
Date submitted
30/01/2020
Date registered
11/01/2022
Date last updated
11/01/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of myofascial release on pain, posture quality and gait in patients aged 22-42 years with chronic lower back pain
Scientific title
Determinants of the quality of life of women with back pain who underwent myofascial therapy.
Secondary ID [1] 300333 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 315975 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314252 314252 0 0
Physiotherapy
Musculoskeletal 314253 314253 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Material
The study group consisted of 40 women with chronic low back pain and 20 healthy peers. The subjects' age ranged between 20-42 years (23.89 ± 5.18). Participation in the study was voluntary.
Description of the Intervention
Women with chronic low back pain were randomly assigned to one of two groups: group one DTM /deep tissue massage/ and group two SI /Structural Integration/.
All DTM and SI women participated in 10 30-minute treatments twice a week at regular time intervals. All treatments were performed by the same experienced physiotherapist. Deep tissue massage in the region of pain was performed in DTM participants. The order and selection of the techniques used were in accordance with the assumptions of the method described by Art Riggs (2012).
The whole body therapy in accordance with the concept of Structural Integration (Jacobson 2011) was applied in SI group. Briefly, the subsequent treatments consisted on (1) breathing release and balance the pelvis (2) balance the foot as a support for standing position (3) extend and balance the lateral side of the body from knee to neck (4) extend the inner side of the lower limb and balance the pelvic floor (5) opening the deeper abdominal walls and balance the front side of the pelvis (6) balance the back side of the pelvis (7) correct positioning of the head (8) integration of the pelvis and lower limbs (9) integration of the shoulder girdle and upper limbs (10) integration of the whole body.
The study was conducted as the double blind randomized controlled trial. The performing therapist did not participate in the measurements, the participants did not know that the therapy was conducted in two ways and the measuring persons did not know to which group the women were qualified.
Intervention code [1] 316642 0
Rehabilitation
Intervention code [2] 317146 0
Treatment: Other
Comparator / control treatment
There were two control groups in this project:
First group: women with chronic back pain participating in the project were examined twice: at the beginning (Study 1) and after four weeks (Study 2)/ to confirm the previous diagnosis /. Between the first and second study women with chronic back pain did not use any physiotherapy procedures. After the second study, women with chronic back pain were treated with musculoskeletal/facial /2 x per week for 5 weeks. After this time they were re-examined (Study 3).
Second control group: women without chronic back pain without any intervention.

Control group
Active

Outcomes
Primary outcome [1] 322640 0
Analysis of the impact of myofascial therapy on selected indicators of quality of life in women with chronic back pain assessed by The World Health Organization Quality of Life (WHOQOL) - BREFF, The Roland-Morris Low Back Pain Disability Questionnaire, Questionnaire Revised Oswestry Low Back Pain Disability Scale
Timepoint [1] 322640 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Primary outcome [2] 322641 0
pain level assessed by a subjective scale (VAS) of 1 to 10
Timepoint [2] 322641 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [1] 379152 0
Influence of myofascial therapy on the quality of body posture in women with chronic back pain assessed by Zebris Poiter
Timepoint [1] 379152 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [2] 379153 0
Influence of myofascial therapy on the symmetry of foot load on body weight in women with chronic back pain assessed by BTS P-WALK baroresist platform
Timepoint [2] 379153 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [3] 379154 0
Impact of myofascial therapy on chest mobility in women with chronic back pain assessed by centimeter tape
Timepoint [3] 379154 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [4] 379155 0
Impact of myofascial therapy on respiratory parameters in women with chronic back pain assessed by the SpiroLab III diagnostic sprirometer
Timepoint [4] 379155 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [5] 379156 0
The effect of myofascial therapy on dorsal extensor activity during simple movements in specific planes in women with chronic lower back pain assessed by Noraxon's 8-channel EMG kit
Timepoint [5] 379156 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [6] 379290 0
Analysis of the effect of myofascial therapy on muscle strength hamstrings assessed by
BIODEX SYSTEM 4 PRO
Timepoint [6] 379290 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [7] 379291 0
Analysis of the effect of myofascial therapy on gait quality assessed by BTS Smart-E (BTS Bioengineering, Milan, Italy)
Timepoint [7] 379291 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)
Secondary outcome [8] 379292 0
Analysis of the effect of myofascial therapy on the rate of contraction and muscle stiffness: Biceps Femoris, Erector Spinae, Latissimus Dorsi, Semitendinosus, Vastus Lateralis assessed by TMG-S1 / tensiomyography /.
Timepoint [8] 379292 0
At baseline (test 1), immediately after four weeks (test 2), immediately after 10 sessions of myofascial therapy (test 3)

Eligibility
Key inclusion criteria
1. age 20-42 years old,
2. voluntary consent to participate in the research.
3. All participants qualified for the study group subjected to 12 weeks of therapy had lower back pain of a chronic nature (40 woman). Additionally, people without lower back pain of a chronic nature participated in the project, acting as a control group (20 woman).
Minimum age
20 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. pregnancy,
2. certificate of disability level,
3. spinal surgery or other surgery performed in the last six months,
4. chronic use of antidepressant, psychotropic, sleeping pills, painkillers,
5. injuries of the musculoskeletal system (fractures, dislocations, sprains) completed within six months before the start of the tests,
6. contraindications for myofascial therapy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical methods / analysis: To assess the correlation coefficient of chosen variables two statistical test will be used – Chi square (x2) and t-Student. For all compared variables the level of relevancywill set at alpha=0,05 (p<0,05). The correlation coefficient with probability of p<0,01 will be recognized as highly relevant, and correlation coefficient with probability of p<0,001 will be recognized as extremely relevant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2019
Date of last participant enrolment
Anticipated
Actual
15/03/2019
Date of last data collection
Anticipated
Actual
24/05/2019
Sample size
Target
62
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 22272 0
Poland
State/province [1] 22272 0

Funding & Sponsors
Funding source category [1] 304758 0
University
Name [1] 304758 0
University of Applied Sciences
Country [1] 304758 0
Poland
Primary sponsor type
University
Name
University of Applied Sciences
Address
ul. Mickiewicza 8
33-100 Tarnów
Country
Poland
Secondary sponsor category [1] 305126 0
None
Name [1] 305126 0
Address [1] 305126 0
Country [1] 305126 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305176 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 305176 0
ul. Krupnicza 11a, 31-123 Krakow
Ethics committee country [1] 305176 0
Poland
Date submitted for ethics approval [1] 305176 0
27/11/2017
Approval date [1] 305176 0
09/01/2018
Ethics approval number [1] 305176 0
28/KBL/OIL/2018

Summary
Brief summary
The aim of the study was to assess the quality of life of patients with chronic lower back pain who underwent myofascial therapy. The analysis also included posture quality, body weight pattern, respiratory parameters and dorsal extensor activity.
The study group consisted of 60 women, volunteers with chronic lower back pain. Participation in the study was voluntary. Women with chronic low back pain were randomly assigned to one of two groups: group one DTM /deep tissue massage/ and group two SI /Structural Integration/.
All DTM and SI women participated in 10 30-minute treatments twice a week at regular time intervals. All treatments were performed by the same experienced physiotherapist. Deep tissue massage in the region of pain was performed in DTM participants. The whole body therapy in accordance with the concept of Structural Integration was applied in SI group.
The women were examined three times, at the beginning of the experiment, after 4 weeks (to confirm the earlier diagnosis) and after 10 sessions of myofascial therapy.
All participants completed the following tests:
• Quality of life survey using The World Health Organization Quality of Life (WHOQOL) questionnaire - BREFF,
• Examination of the intensity of pain perceived - the VAS scale,
• Assessment of disability resulting from felt back pain - Questionnaire Revised Oswestry Low Back Pain Disability Scale - Polish version,
• Roland-Morris Questionnaire,
• Body posture assessment using the Zebris Pointer ultrasonic system with WinSpine software
• Anthropometric measurements: body height, body weight, BMI,
• Assessment of foot load with body weight during free standing on the BTS P-WALK baroresist platform,
• Chest mobility measurements,
• Functional examination of the respiratory system - spirometry,
• Examination of dorsal extensor activity - sEMG (surface electromyography set).
• Gait and dynamic muscle activity testing during gait using the BTS SMART system
• Muscle strength assessment during concentric and eccentric work of selected lower limb muscles
• Assessment of contractions speed and muscle stiffness of selected muscle groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99498 0
Mrs Eliza Smola
Address 99498 0
University of Applied Sciences
ul. Mickiewicza 8
33-100 Tarnów
Country 99498 0
Poland
Phone 99498 0
+48 667 950 985
Fax 99498 0
+48 14 631 66 00
Email 99498 0
[email protected]
Contact person for public queries
Name 99499 0
Eliza Smola
Address 99499 0
University of Applied Sciences
ul. Mickiewicza 8
33-100 Tarnów
Country 99499 0
Poland
Phone 99499 0
+48 667 950 985
Fax 99499 0
+48 14 631 66 00
Email 99499 0
[email protected]
Contact person for scientific queries
Name 99500 0
Eliza Smola
Address 99500 0
University of Applied Sciences
ul. Mickiewicza 8
33-100 Tarnów
Country 99500 0
Poland
Phone 99500 0
+48 667 950 985
Fax 99500 0
+48 14 631 66 00
Email 99500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data are available from the authors and may be available privately.


What supporting documents are/will be available?




Results publications and other study-related documents

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