Low Back Pain (LBP)HSTP HydrationNCT07915167
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
A study testing hydration, Stecco's Fascial Manipulation therapy and Stecco Fascial Manipulation Therapy + Hydration in people with Low Back Pain (LBP) and Fascial Manipulation, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain (LBP), Fascial Manipulation, Hydration
- What is being tested?
- hydration, Stecco's Fascial Manipulation therapy and Stecco Fascial Manipulation Therapy + Hydration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 15 Nov 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- People 18-30 years old,
- pain 0-7 on the VAS scale,
- no metabolic and general diseases,
- not taking muscle relaxants or permanent drugs,
- no hormonal problems or hormonal treatment,
- BMI<30.
Who cannot join
- no consent to participate in the study,
- competitive sports,
- supplementation with drugs that may affect diuresis,
- surgery less than 6 months before the test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
The Jerzy Kukuczka Academy of Physical Education in Katowice
Katowice
About this study
Official title: Evaluation of the Impact of Hydration and Fascial Therapy on Pain in the Lumbar Spine and Patient Functionality.
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.
Read the detailed description
- Participant recruitment and eligibility assessment Participants aged 18-30 years who meet the predefined inclusion and exclusion criteria will be invited to participate in the study. Before any study procedures are performed, participants will receive information about the study and provide written informed consent.
- 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.
- Baseline questionnaires At the beginning of the study, participants will complete the required questionnaires (Szymon Sadowski). Pain intensity will be assessed using the Visual Analogue Scale (VAS), and disability associated with low back pain will be assessed using the Oswestry Disability Index version 2.1a (ODI 2.1a). Participants will also complete a questionnaire assessing their habitual water and fluid intake.n addition, a personal questionnaire will be completed to collect basic anthropometric, lifestyle, and health-related information. The questionnaire will include body height (cm), body weight (kg), and body mass index (BMI; kg/m²), as well as information on the participant's level of physical activity and its frequency during the week. Participants will also report the type of their usual occupation, categorized as physically demanding, mentally demanding, predominantly standing, or predominantly sedentary work. Information regarding average sleep duration and subjective mood assessment will also be collected.These data will be used to characterize the study population and to identify potential factors that may influence hydration status, pain intensity, tissue mechanical properties, and physical performance. The collected information will be recorded at baseline and, where relevant, considered when interpreting differences between study groups and changes observed during the study.
- Baseline hydration assessment Participants will undergo an assessment of hydration status. Body composition and hydration-related parameters will be measured using bioelectrical impedance analysis (BIA). In addition, a urine sample will be collected and assessed using Armstrong's Urine Colour Chart and diagnostic urine test strips (Julia Morys). The urine sample will be analyzed by a qualified member of the research team.
- Physical performance assessment Lower-limb explosive performance will be assessed using the Squat Jump test. Participants will perform the test on a Chronojump (Oliwia Doległo and Anna Bąchór) measurement system according to a standardized testing procedure. The obtained jump-performance data will be recorded for subsequent analysis. Additionally, a functional test measuring the finger-to-floor distance will be performed to assess the overall spinal mobility of the subjects.
- 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.
- Monitoring of water intake Participants assigned to the hydration groups will be asked to install a free hydration-monitoring application or, alternatively, use a paper-based water intake diary. Throughout the intervention period, participants will record their daily intake of plain water only, with each intake episode documented in the designated hourly drinking diary. Participants will be instructed to increase their daily plain-water intake to approximately 3 L per day. To facilitate a regular distribution of water consumption throughout the day, participants will be advised to consume approximately 250 mL of plain water per hour during their waking hours, rather than consuming large volumes at a single time. This recommendation is intended to promote a consistent pattern of water intake and facilitate achievement of the prescribed daily target.Participants will record the time and volume of each water intake episode (mL) in the application or paper diary. The hourly recording will allow the research team to monitor both the total daily amount of plain water consumed and the distribution of water intake throughout the day. Participants will be instructed to record the actual volume consumed, rather than simply marking whether water was consumed during a given hour.The recorded data will be used to calculate the participant's daily plain-water intake, mean daily intake over the intervention period, and adherence to the prescribed approximately 3-L daily target. The records will also allow assessment of whether water consumption was distributed relatively evenly throughout the day, including identification of periods of low or unusually high intake.Participants will be reminded that the prescribed intake refers specifically to plain water and does not include coffee, tea, juices, soft drinks, energy drinks, or other beverages. Other beverages may be recorded separately if required by the study protocol, but they will not contribute to the approximately 3-L plain-water intervention target.The hydration-monitoring records will be collected or exported at the end of the intervention period and included in the study database.
- 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.
- Completion of the intervention period After completion of the intervention period, all participants will undergo the same assessment procedures as at baseline. The VAS, ODI 2.1a, BIA, MyotonPRO, Squat Jump, Armstrong's Urine Colour Chart, and urine diagnostic assessment will be repeated using the same standardized procedures.
- Follow-up assessment Four weeks after completion of the intervention period, participants will undergo a follow-up examination. No further study intervention will be provided during this period. The same assessment protocol will be used to determine whether any changes observed after the intervention are maintained over time.
- Data analysis The results obtained at baseline, after completion of the intervention, and at follow-up will be compared within and between study groups. The analysis will focus on changes in hydration status, tissue mechanical properties, pain intensity, functional disability, and physical performance, as well as the relationship between hydration-related changes and the assessed clinical and functional outcomes.
- Conditions
- Low Back Pain (LBP), Fascial Manipulation, Hydration, Mobility Decline, Jumping Performance, Bioimpedance Measurement Capacity
- Being tested
- hydration, Stecco's Fascial Manipulation therapy, Stecco Fascial Manipulation Therapy + Hydration, Simulated non-interventional soft-tissue therapy
- Keywords
- fascia, viscoelastic properties, hydration, low back pain, fascial manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrationOther
mentioned in the description of the research groups
Stecco's Fascial Manipulation therapyOther
mentioned in the description of the research groups
Stecco Fascial Manipulation Therapy + HydrationOther
mentioned in the description of the research groups
Simulated non-interventional soft-tissue therapyOther
only a gentle touch without pressure on the areas where Stecco's fascial manipulation therapy would normally be performed
| Study group | Role | What they receive |
|---|---|---|
| Only Water Group | Experimental | increasing fluid intake to approximately 3 liters per day Receives: Other: hydration |
| Fascial Manipulation Group | Experimental | 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. Receives: Other: Stecco's Fascial Manipulation therapy |
| Fascia and Water Group | Experimental | 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. Receives: Other: Stecco Fascial Manipulation Therapy + Hydration |
| Control and Draw Group | Other | 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 Receives: Other: hydration; Other: Stecco's Fascial Manipulation therapy; Other: Stecco Fascial Manipulation Therapy + Hydration |
| Control Group | Placebo comparator | asymptomatic individuals; simulated non-interventional soft-tissue therapy, measurements according to the protocol Receives: Other: Simulated non-interventional soft-tissue therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]
Measured: 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
Measured: 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.
Measured: 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]
Measured: 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]
Measured: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain (LBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Classical experiment with control group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliwia Doległo, Student, Study chairAnna Bąchór, Student, Study chairJakub Wojtyłka, Student, Study chairWiktor Kasprzykowski, Student, Study chairJulia Morys, Master's degree, Study chairSzymon Sadowski, Student, Study chairKacper Chojowski, Master's degree, Study directorMichał Kuszewski, Doktor Habilitowany, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915167
- Sponsor's protocol ID
- SFP nr 04/03/2026
- Acronym
- HSTP Hydration
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Hydration and Fascial Therapy on Pain in the Lumbar Spine and Patient Functionality.
- ClinicalTrials.gov ID
- NCT07915167
- Acronym / sponsor ID
- HSTP Hydration / SFP nr 04/03/2026
- Conditions
- Low Back Pain (LBP), Fascial Manipulation, Hydration, Mobility Decline, Jumping Performance, Bioimpedance Measurement Capacity
- Keywords
- fascia, viscoelastic properties, hydration, low back pain, fascial manipulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Participant recruitment and eligibility assessment Participants aged 18-30 years who meet the predefined inclusion and exclusion criteria will be invited to participate in the study. Before any study procedures are performed, participants will receive information about the study and provide written informed consent.
- 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.
- Baseline questionnaires At the beginning of the study, participants will complete the required questionnaires (Szymon Sadowski). Pain intensity will be assessed using the Visual Analogue Scale (VAS), and disability associated with low back pain will be assessed using the Oswestry Disability Index version 2.1a (ODI 2.1a). Participants will also complete a questionnaire assessing their habitual water and fluid intake.n addition, a personal questionnaire will be completed to collect basic anthropometric, lifestyle, and health-related information. The questionnaire will include body height (cm), body weight (kg), and body mass index (BMI; kg/m²), as well as information on the participant's level of physical activity and its frequency during the week. Participants will also report the type of their usual occupation, categorized as physically demanding, mentally demanding, predominantly standing, or predominantly sedentary work. Information regarding average sleep duration and subjective mood assessment will also be collected.These data will be used to characterize the study population and to identify potential factors that may influence hydration status, pain intensity, tissue mechanical properties, and physical performance. The collected information will be recorded at baseline and, where relevant, considered when interpreting differences between study groups and changes observed during the study.
- Baseline hydration assessment Participants will undergo an assessment of hydration status. Body composition and hydration-related parameters will be measured using bioelectrical impedance analysis (BIA). In addition, a urine sample will be collected and assessed using Armstrong's Urine Colour Chart and diagnostic urine test strips (Julia Morys). The urine sample will be analyzed by a qualified member of the research team.
- Physical performance assessment Lower-limb explosive performance will be assessed using the Squat Jump test. Participants will perform the test on a Chronojump (Oliwia Doległo and Anna Bąchór) measurement system according to a standardized testing procedure. The obtained jump-performance data will be recorded for subsequent analysis. Additionally, a functional test measuring the finger-to-floor distance will be performed to assess the overall spinal mobility of the subjects.
- 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.
- Monitoring of water intake Participants assigned to the hydration groups will be asked to install a free hydration-monitoring application or, alternatively, use a paper-based water intake diary. Throughout the intervention period, participants will record their daily intake of plain water only, with each intake episode documented in the designated hourly drinking diary. Participants will be instructed to increase their daily plain-water intake to approximately 3 L per day. To facilitate a regular distribution of water consumption throughout the day, participants will be advised to consume approximately 250 mL of plain water per hour during their waking hours, rather than consuming large volumes at a single time. This recommendation is intended to promote a consistent pattern of water intake and facilitate achievement of the prescribed daily target.Participants will record the time and volume of each water intake episode (mL) in the application or paper diary. The hourly recording will allow the research team to monitor both the total daily amount of plain water consumed and the distribution of water intake throughout the day. Participants will be instructed to record the actual volume consumed, rather than simply marking whether water was consumed during a given hour.The recorded data will be used to calculate the participant's daily plain-water intake, mean daily intake over the intervention period, and adherence to the prescribed approximately 3-L daily target. The records will also allow assessment of whether water consumption was distributed relatively evenly throughout the day, including identification of periods of low or unusually high intake.Participants will be reminded that the prescribed intake refers specifically to plain water and does not include coffee, tea, juices, soft drinks, energy drinks, or other beverages. Other beverages may be recorded separately if required by the study protocol, but they will not contribute to the approximately 3-L plain-water intervention target.The hydration-monitoring records will be collected or exported at the end of the intervention period and included in the study database.
- 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.
- Completion of the intervention period After completion of the intervention period, all participants will undergo the same assessment procedures as at baseline. The VAS, ODI 2.1a, BIA, MyotonPRO, Squat Jump, Armstrong's Urine Colour Chart, and urine diagnostic assessment will be repeated using the same standardized procedures.
- Follow-up assessment Four weeks after completion of the intervention period, participants will undergo a follow-up examination. No further study intervention will be provided during this period. The same assessment protocol will be used to determine whether any changes observed after the intervention are maintained over time.
- Data analysis The results obtained at baseline, after completion of the intervention, and at follow-up will be compared within and between study groups. The analysis will focus on changes in hydration status, tissue mechanical properties, pain intensity, functional disability, and physical performance, as well as the relationship between hydration-related changes and the assessed clinical and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- Classical experiment with control group
| Arm | Type | Receives |
|---|---|---|
| Only Water Group | Experimental | Other: hydrationincreasing fluid intake to approximately 3 liters per day |
| Fascial Manipulation Group | Experimental | Other: Stecco's Fascial Manipulation therapytherapy 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. |
| Fascia and Water Group | Experimental | Other: Stecco Fascial Manipulation Therapy + Hydrationtherapy 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. |
| Control and Draw Group | Other | Other: hydration, Other: Stecco's Fascial Manipulation therapy, Other: Stecco Fascial Manipulation Therapy + Hydrationwill 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 |
| Control Group | Placebo comparator | Other: Simulated non-interventional soft-tissue therapyasymptomatic individuals; simulated non-interventional soft-tissue therapy, measurements according to the protocol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- People 18-30 years old,
- pain 0-7 on the VAS scale,
- no metabolic and general diseases,
- not taking muscle relaxants or permanent drugs,
- no hormonal problems or hormonal treatment,
Key exclusion criteria (4 listed)
- no consent to participate in the study,
- competitive sports,
- supplementation with drugs that may affect diuresis,
- surgery less than 6 months before the test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrationmentioned in the description of the research groups | Other | Control and Draw Group, Only Water Group |
| Stecco's Fascial Manipulation therapymentioned in the description of the research groups | Other | Control and Draw Group, Fascial Manipulation Group |
| Stecco Fascial Manipulation Therapy + Hydrationmentioned in the description of the research groups | Other | Control and Draw Group, Fascia and Water Group |
| Simulated non-interventional soft-tissue therapyonly a gentle touch without pressure on the areas where Stecco's fascial manipulation therapy would normally be performed | Other | Control Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Oswestry Questionnaire
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Hydration
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Vertical jump
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 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.
Armstrong's Urine Colour Chart
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Urine assessment using diagnostic test strips
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Water and Fluid Intake Habits Questionnaire (NAS)
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Muscle Tone
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Stiffness
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Relaxation
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
BMI
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
To calculate BMI, need parameters such as height in centimeters [cm] and body weight in kilograms [kg]
Physical activity
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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
Total water content (TBW)
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
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.
Intracellular water (ICW)
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Hydration status was assessed using bioelectrical impedance analysis (BIA). Distribution of water into intracellular and extracellular compartments, in liters [L] or kilograms [kg]
Extracellular water (ECW)
Time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)
Hydration status was assessed using bioelectrical impedance analysis (BIA). Distribution of water into intracellular and extracellular compartments, in liters [L] or kilograms [kg]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliwia Doległo, Student study chair
Anna Bąchór, Student study chair
Jakub Wojtyłka, Student study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydration, Stecco's Fascial Manipulation therapy and Stecco Fascial Manipulation Therapy + Hydration in people with Low Back Pain (LBP) and Fascial Manipulation, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: From the time of inclusion in the study until its completion after 8 weeks (4 weeks + follow-up after 4 weeks)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.