An interventional study of hydration and Stecco's Fascial Manipulation therapy in Low Back Pain (LBP), Fascial Manipulation and Hydration, sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice. Enrolling by invitation at 1 site in Poland. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by The Jerzy Kukuczka Academy of Physical Education in Katowice · Not applicable, Interventional, and Treatment
The study aims to examine the effect of hydration and therapy fascia manipulation on soft tissues and compare their effects. The affected factors will be checked for the impact on pain felt in patients and motor movement.
Assessment of tissue mechanical properties The mechanical properties of selected tissues will be assessed using the MyotonPRO device (Wiktor Kasprzykowski and Jakub Wojtyłka). Measurements will be performed at predefined myofascial points based on the Stecco® Fascial Manipulation model, located in the trunk, pelvis, hip, thigh, and knee regions and corresponding to the Th, Lu, Pv, Cx, and Ge segments.
The assessment of each segment will include six myofascial points corresponding to the myofascial sequences, in accordance with the Stecco method. The measurements will be performed bilaterally where applicable. A total of 57 myofascial points will be assessed across both sides of the body, including three points located on the body's midline, which will be assessed only once. Before commencement of the study measurements, all individuals responsible for performing the MyotonPRO assessments will undergo standardized training in the identification and localization of the relevant myofascial points according to the Stecco® Fascial Manipulation model. The training will be conducted by a certified therapist in the Stecco method, Kacper Chojowski, MSc. This training is intended to ensure consistent anatomical localization of the measurement points and improve the reproducibility of measurements between examiners.
The MyotonPRO assessment is non-invasive and painless. The same anatomical landmarks, measurement points, participant positioning, measurement procedure, and device settings will be used at each assessment time point whenever possible. The obtained measurements will be recorded for each participant and subsequently analyzed to evaluate changes in tissue mechanical properties associated with the study interventions.
Group allocation
After completion of the baseline assessment, participants will be randomly assigned to one of four groups:
Only Water Group - participants will increase their intake of plain water to approximately 3 L per day.
Fascial Manipulation Group - participants will receive three individually tailored Fascial Manipulation® sessions according to the Stecco concept, administered at two-week intervals.
Fascia and Water Group - participants will receive both interventions: three Fascial Manipulation® sessions and an increase in plain-water intake to approximately 3 L per day.
Control and Draw group - participants will undergo the assessment procedures without receiving an intervention during the main study period.
Control group - asymptomatic individuals; a gentle touch without pressure on the areas where Stecco's fascial manipulation therapy would normally be performed, measurements according to the protocol.
Fascial Manipulation intervention Participants allocated to the Fascial Manipulation groups will undergo three treatment sessions, with an interval of two weeks between consecutive sessions. The intervention will be performed according to the Fascial Manipulation® method developed by Luigi Stecco, using a standardized diagnostic and therapeutic approach. Before each treatment, participants will undergo an individualized assessment performed by a certified therapist trained in the Stecco method. The assessment will include the collection of information regarding the participant's symptoms, pain characteristics, functional limitations, and relevant movement-related complaints. The therapist will use the participant's clinical presentation and the principles of the Stecco Fascial Manipulation model to identify potentially dysfunctional myofascial units and corresponding treatment points. Within the Stecco model, treatment is based on the identification of specific myofascial points (Centres of Coordination, CCs) associated with coordinated movement and located within defined anatomical regions and myofascial sequences. The therapist will assess the relevant points according to the participant's symptoms and the functional pattern identified during the diagnostic examination. Treatment points will therefore be individually selected for each participant rather than being predetermined identically for all participants. The selected points will be treated using manual friction applied to the identified myofascial areas. The intervention is intended to influence the mechanical and functional properties of the fascial tissue and to restore more appropriate tissue gliding and coordination within the corresponding myofascial sequences. The treatment will be performed directly on the selected myofascial points identified during the diagnostic assessment, rather than by applying a generalized massage or whole-body manual therapy protocol. The number and anatomical location of treated points may therefore differ between participants depending on the clinical findings and the individualized diagnostic assessment. The therapist will document the anatomical location of the treated points and the treatment performed during each session to allow monitoring of treatment exposure and facilitate reproducibility of the intervention. The three treatment sessions will be performed at two-week intervals. At subsequent sessions, the participant will be reassessed, and the treatment may be modified according to the current clinical presentation and the response to the previous session. This approach reflects the individualized nature of the Stecco Fascial Manipulation method while maintaining a standardized overall treatment schedule across participants.
The Fascial Manipulation intervention will be performed by certified therapists trained in the Stecco method, Kacper Chojowski and Michał Kuszewski. The therapists will follow the same diagnostic and therapeutic principles and will use the same study-specific protocol for identifying, documenting, and treating the selected myofascial points.
2,884 studies on the registry are indexed under Low Back Pain; 483 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 2,324 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →The Jerzy Kukuczka Academy of Physical Education in Katowice is the lead sponsor of 31 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
increasing fluid intake to approximately 3 liters per day
Other: hydration
therapy consisting of: Fascial Manipulation according to Stecco (3 sessions every two weeks during the experiment). The therapy is tailored individually for each participant based on a personalized diagnosis performed by a certified therapist.
Other: Stecco's Fascial Manipulation therapy
therapy consisting of: Fascial Manipulation according to Stecco (3 sessions every two weeks during the experiment) and increasing fluid intake to approximately 3 liters per day. The therapy is tailored individually for each participant based on a personalized diagnosis performed by a certified therapist.
Other: Stecco Fascial Manipulation Therapy + Hydration
will undergo only examination without intervention; however, after the study period ends, these participants will be randomly assigned to one of the groups A, B, or C
Other: hydration · Other: Stecco's Fascial Manipulation therapy · Other: Stecco Fascial Manipulation Therapy + Hydration
asymptomatic individuals; simulated non-interventional soft-tissue therapy, measurements according to the protocol
Other: Simulated non-interventional soft-tissue therapy
mentioned in the description of the research groups
mentioned in the description of the research groups
mentioned in the description of the research groups
only a gentle touch without pressure on the areas where Stecco's fascial manipulation therapy would normally be performed
Visual Analog Scale (VAS)
Pain intensity was assessed using a Visual Analogue Scale (VAS), consisting of a 100-mm horizontal line anchored by two endpoints: 0 mm, indicating "no pain," and 100 mm, indicating "worst pain imaginable. The distance from the zero point to the participant's mark was measured in millimetres, with higher scores indicating greater pain intensity.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Oswestry Questionnaire
Disability related to low back pain was assessed using the Oswestry Disability Index, version 2.1a (ODI 2.1a). The questionnaire consists of 10 sections assessing pain intensity and the impact of low back pain on activities of daily living, including personal care, lifting, walking, sitting, standing, sleeping, social life, and travelling. Each section is scored from 0 to 5, with higher scores indicating greater disability. The scores from all completed sections are summed and expressed as a percentage of the maximum possible score, ranging from 0% to 100%. Higher ODI scores indicate a greater level of disability associated with low back pain.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Hydration
Water intake was assessed using an individual water intake questionnaire provided to each participant at the beginning of the study. Participants were instructed to record the amount of water consumed, expressed in millilitres (mL), at specified time points throughout the study period. Each participant was required to complete the questionnaire on an ongoing basis and record their water intake at the designated times. Upon completion of the study, the questionnaires were collected from all participants, and the recorded values were reviewed and summarized to determine the total water intake and the pattern of water consumption during the study period.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Vertical jump
Vertical jump performance was assessed using the Squat Jump (SJ) test with the Chronojump measurement system. Jump height was recorded using the Chronojump system based on the measured flight time and is specified in centimeters \[cm\]. The obtained results were recorded for each participant and subsequently analyzed to assess lower-limb explosive performance.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Armstrong's Urine Colour Chart
Hydration status was additionally assessed using Armstrong's Urine Colour Chart. Participants were instructed to compare the colour of their urine with the standardized colour scale provided by the chart and to record the corresponding score. The chart consists of eight colour categories ranging from very pale yellow to dark brown, with lower scores indicating lighter urine colour and better hydration status, while higher scores indicate darker urine colour and a greater likelihood of dehydration.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Urine assessment using diagnostic test strips
Urine parameters were assessed using commercially available urine diagnostic test strips. Urine samples were collected from each participant at the designated time points during the study period. The test strip was immersed in the urine sample according to the manufacturer's instructions and subsequently evaluated after the specified reaction time. The obtained results were used to assess selected urine parameters related to hydration status, including urine specific gravity and other relevant biochemical indicators.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Water and Fluid Intake Habits Questionnaire (NAS)
The questionnaire was administered prior to the commencement of any intervention in order to characterize participants' baseline hydration-related habits and usual fluid consumption. The questionnaire included questions regarding the usual amount and frequency of fluid intake, the types of beverages consumed, and participants' subjective hydration-related habits and symptoms potentially associated with insufficient fluid intake.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Muscle Tone
Soft tissue properties were assessed using the MyotonPRO device examined F - Natural Oscillation Frequency \[Hz\], characterizing Tone or Tension at the points specified earlier in the study description.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Stiffness
Soft tissue biomechanics properties were assessed using the MyotonPRO device examined S - Dynamic Stiffness \[N/m\] at the points specified earlier in the study description.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Relaxation
Soft tissue viscoelastic properties were assessed using the MyotonPRO device examined R - Mechanical Stress Relaxation Time \[ms\] at the points specified earlier in the study description.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
BMI
To calculate BMI, need parameters such as height in centimeters \[cm\] and body weight in kilograms \[kg\]
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Physical activity
Determining the level of overall weekly physical activity using the PAL (Physical Activity Level) coefficient. * Extremely inactive / Bed Rest: \< 1.2 - 1.4 (Confined to bed, minimal movement) * Sedentary: 1.40 - 1.69 (Seated work, office jobs, little or no strenuous leisure, \~7,500 steps/day) * Moderately Active: 1.70 - 1.99 (Standing/walking work, or seated work plus \~1 hour of daily exercise like running/brisk walking) * Vigorously / Heavily Active: 2.00 - 2.40 (Heavy physical/agricultural labor, construction, or 2+ hours of intense daily training) * Extremely Active: \> 2.40 (Competitive endurance athletes, heavy double-daily training regimens
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Total water content (TBW)
Hydration status was assessed using bioelectrical impedance analysis (BIA). Total body water is calculated and expressed in liters \[L\] and as a percentage \[%\] of body mass.
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Intracellular water (ICW)
Hydration status was assessed using bioelectrical impedance analysis (BIA). Distribution of water into intracellular and extracellular compartments, in liters \[L\] or kilograms \[kg\]
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Extracellular water (ECW)
Hydration status was assessed using bioelectrical impedance analysis (BIA). Distribution of water into intracellular and extracellular compartments, in liters \[L\] or kilograms \[kg\]
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 1,196 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 7 months is below that.
Counting every sponsor, half of 1,256 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The Jerzy Kukuczka Academy of Physical Education in Katowice