Sacroiliac DysfunctionLOUISNCT06710535
Sacroiliac Joint Dysfunction Consequences and Its Reversal by Manipulation
A study testing Manual Manipulation in people with Sacroiliac Dysfunction, run by Aveiro University at 1 site in Portugal.
Trial summary
Sacroiliac joint dysfunction (ASI) is an alteration in the normal biomechanics of the joint, which leads to hypomobility or hypermobility of that joint. It is one of the most common causes of misdiagnosis in low back pain and when not treated correctly, it often evolves into chronic pain (30% to 42%) and disability. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Dysfunction
- What is being tested?
- Manual Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Feb 2025to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with sacroiliac joint dysfunction demonstrated
- Students of Aveiro University
- Aged between 18 and 30 years
Who cannot join
- Individuals with neurological injuries
- Subject to another type of therapeutic intervention, during the intervention period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Global Changes Associated With Sacroiliac Joint Dysfunction and Its Reversal by Manipulation - A Randomized Controlled Trial
Sacroiliac joint dysfunction (ASI) is an alteration in the normal biomechanics of the joint, which leads to hypomobility or hypermobility of that joint. It is one of the most common causes of misdiagnosis in low back pain and when not treated correctly, it often evolves into chronic pain (30% to 42%) and disability. Manipulating the dysfunctional ASI appears to result in benefits and significantly positive changes at various levels, in all segments of the human body. With this investigation, the investigators intend to clarify and deepen the possible correlation between the changes that normally accompany this dysfunction, as well as its possible reversibility with its normalization.- Objectives
- The investigators will essentially have two main objectives:
Read more
- Mapping of the most evident symptomatic changes, when sacroiliac joint dysfunction is present, in terms of pain, balance and gait ;
- To try to understand the immediate, global and short-term effect of ASI manipulation, studying the cumulative effect of six sessions and the possible interrelationship between the changes recorded.
- Study design Quantitative, with experimental study design, RCT, with the sample comprising individuals with SIJ dysfunction, where all participants in study 2 will be randomly allocated to the experimental, control and placebo groups. It will be carried out at the University of Aveiro facilities. Initially, the investigators will map the changes present at a physical level, followed by manipulation, evaluating the immediate effect, measuring the degree of pain, unipodal balance and satisfaction with the treatment. The investigators will then evaluate the effect of 3 sessions, on a weekly basis, for 3 weeks.
- Material and methods The investigators will make use of:
- Standing flexion test, to define the laterality of the dysfunction;
- VAS , to subjectively assess pain;
- Pressure algometer, to objectively assess pain ;
- Force Platform, to assess balance;
- G-Walk, for gait assessment;
- PGIC, to assess satisfaction with treatment ;
Read the detailed description
Procedures to be used in the Experimental Study Material and methods
Reception of participants, with a clear explanation of the objectives and procedures to be used in the pilot study, asking them to fill out:
- an informed consent model; 2. a sociodemographic and health data questionnaire; 3. a participant recruitment form (all of which were previously approved by the Data Protection Officer and the Ethics and Deontology Council of the University of Aveiro); 4. Select the study participants, assessing the presence of Sacroiliac Joint Dysfunction, for which the investigators will use the following procedures, using a multitest assessment, which consists of using a combination of palpation and pain provocation tests, which exhibits sufficient validity and reliability in the diagnosis of sacroiliac joint dysfunction ( Telli et al., 2018); 4. 1 - Bending test in foot - Performed by palpating the posterior superior iliac spine (PSIS) while the person is bending forward from the standing position. The test is negative if PSISs appear to move equally and sym - metrically, or positive on the side in which the PSIS moves crani - ally and ventrally more than the other side. A positive result indicates limited movement of the ilium on the sacrum, and therefore limited SIJ movement on the side of the superior PSIS ( Ribeiro et al, 2021); 4.2 - Bending test sitting - Similar to the standing flexion test, but the persons starts from the sitting position. The test is negative if PSISs appear to move equally and symmetrically, and positive on the side on which the PSIS moves cranially and ventrally more than the other side. A positive result indicates limited movement of the sacrum on the ilium, and therefore limited SIJ movement on the side of the superior PSIS (Ribeiro et al, 2021); 4.3 - Thigh thrust test (POSH) - The patient lies in a supine position. The hip is brought to 90º flexion. Pressure is applied directly toward the examination table. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation is established with hip flexion and adduction ( Telli et al, 2018); 4.4 - Sacral thrust test - The patient lies in a prone position. The practitioner places one hand on the apex of the sacrum while applying direct pressure with the other hand ( Telli et al, 2018); 4.5 - FABER test - The patient lies in a supine position, while the practitioner stands beside the patient and bends the patient's knee, bringing the heel to the opposite knee. With the other hand, the investigator ensures that the contralateral anterior superior iliac spine remains in a neutral position. The doctor applies mild pressure to the bent knee. Pressure is assumed to be applied to the bilateral sacroiliac ligaments and hip joints. Pain provocation occurs with flexion, abduction and external rotation of the hip ( Telli et al, 2018)
Participants who test positive in at least 4 of the 5 tests mentioned above will be selected to participate in the following studies:
- PHASE 1 Objective : mapping of changes present in selected individuals with SIJ dysfunction, in terms of pain, unipedal static balance and gait;
Variables :
- Pain;
- Static balance;
- Single-leg static balance;
- Gait assessment;
Instruments : -
- Visual Analogue Scale (VAS) , to assess the subjective sensation of pain perceived by the participant;
- Pressure Algometer , to assess pain, used at the following points:
- Lower limbs: muscular belly of the external calves, 8 cm below their origin and muscular belly of the internal calves, 12 cm below the origin, cuboids and tarsal naviculars, external and internal joint interline, middle third, in both knees
- Upper limbs: bilaterally at the level of the muscular belly of the short portion of the biceps brachii, 9 cm above the elbow crease and muscular belly of the long portion of the same muscle, 9 cm above the elbow crease , epicondyle and epitrochlea.
- Cervical spine: At the level of the transverse processes of C4, bilaterally;
- Lumbar spine: At the level of the transverse processes of L3, bilaterally;
- Sacroiliac joints bilaterally, at the level of the posterior superior iliac spine, bilaterally;
- Craniocervical transition, bilaterally, at the level of the occipital origin of the upper trapezius muscle;
- Force platform , to assess single-leg static balance;
- G-Walk, wearable inertial sensor for motion analysis, for gait assessment;
- PHASE 2 Objective : To evaluate the immediate effect of ASI manipulation, assessing the variables at the beginning and end of the first session, regarding pain, balance, gait assessment, overall perception of change and satisfaction with the intervention, with weekly frequency, for 3 weeks.
Clinical trial (RCT), in which participants will be randomly divided into 3 groups:
- Experimental group , subject to manipulation performed by the same Physiotherapist, using the techniques described by Shadmehr, A. et al (2018);
- Sham Group , subjected only to a simulation of manipulation, using the same gestures, but without manipulating, used as a placebo group;
- Control group , which will not be subject to any intervention.
Variables :
- Pain;
- Single-leg static balance;
- Gait assessment;
- Perception of change and satisfaction with treatment.
Instruments:
- VAS, used before and immediately after the intervention ;
- Pressure algometer, evaluating before and immediately after the intervention ;
- Force platform;
- G-Walk, wearable inertial sensor for motion analysis, for gait assessment;
- PGIC , to assess the perception of change and satisfaction with treatment, immediately after the last treatment;
- Conditions
- Sacroiliac Dysfunction
- Being tested
- Manual Manipulation, Sham Manipulation
- Keywords
- pain, single-leg static balance, Gait assessment, sacroiliac joint manipulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ManipulationOther
The participants will receive one session of manipulation if in the experimental group. It should be mentioned that the technique will be carried out by a physiotherapist with a history of more than 10 years of manual therapy. For instance, to correct right anterior innominate rotation, the participant will be made to lie on the side so that the affected side is upward. The physiotherapist will stand in front of the participant; first we will put their shoulders, pelvis and lower limbs in neutral position and place the right hand on the anterior superior iliac spine (ASIS) and the left hand on the ischium tuberosity and with a rotational movement of the hands, the physiotherapist will rotate the ilium posteriorly. At the end of the range, we will replace the position of hands and place the left forearm on the ischium tuberosity and place the right hand on the upper participant's shoulder and will move it toward the bed at the end of the range in exhalation a thrust will be executed.
Sham ManipulationOther
The participants will receive one session of sham manipulation if in the sham group. For instance, to correct right anterior innominate rotation, the participant will be made to lie on the side so that the affected side is upward. The physiotherapist will stand in front of the participant; first we will put their shoulders, pelvis and lower limbs in neutral position and place the right hand on the anterior superior iliac spine (ASIS) and the left hand on the ischium tuberosity and with a rotational movement of the hands, the physiotherapist will rotate the ilium posteriorly. At the end of the range, we will replace the position of hands and place the left forearm on the ischium tuberosity and place the right hand on the upper participant's shoulder and will move it toward the bed at the end of the range in exhalation, the physiotherapist will pretend to execute a thrust.
| Study group | Role | What they receive |
|---|---|---|
| Manual manipulation | Experimental | Experimental group, subject to manipulation performed by the same Physiotherapist, using the techniques described by Shadmehr, A. et al (2018). Receives: Other: Manual Manipulation |
| Sham Manipulation | Sham comparator | Sham group, subjected only to a simulation of manipulation, using the same gestures, but without manipulating, used as a placebo group. Receives: Other: Sham Manipulation |
| Control Group | No intervention | Control group, which will not be subject to any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain Assessment
Pain will be assessed with the Visual Analogue Scale (VAS), a horizontal line graded 0 (better outcome) to 10 (worse outcome).
Measured: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]
Algometry Pain Assessment
Pressure algometer
Measured: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week
Single-leg balance
Assess single-leg balance with a force platform
Measured: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]
Gait parameters
Assess gait parameters with G-Walk, a wearable inertial sensor for motion analysis
Measured: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week
Global perception of change and satisfaction with treatment
PGIC ( Patient Global Improvement Change Scale ) - is an instrument for measuring and evaluating the global perception of change and satisfaction with treatment, used in any health condition, unidimensional, with a scoring system on a positive orientation scale from 1 to 7, with a completion time of 1 minute*.
Measured: Immediately after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start10 Feb 2025
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac DysfunctionStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luís Filipe Albuquerque, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710535
- Sponsor's protocol ID
- Aveiro University
- Acronym
- LOUIS
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Changes Associated With Sacroiliac Joint Dysfunction and Its Reversal by Manipulation - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06710535
- Acronym / sponsor ID
- LOUIS / Aveiro University
- Conditions
- Sacroiliac Dysfunction
- Keywords
- pain, single-leg static balance, Gait assessment, sacroiliac joint manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 29 Nov 2024 (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.
Sacroiliac joint dysfunction (ASI) is an alteration in the normal biomechanics of the joint, which leads to hypomobility or hypermobility of that joint. It is one of the most common causes of misdiagnosis in low back pain and when not treated correctly, it often evolves into chronic pain (30% to 42%) and disability. Manipulating the dysfunctional ASI appears to result in benefits and significantly positive changes at various levels, in all segments of the human body. With this investigation, the investigators intend to clarify and deepen the possible correlation between the changes that normally accompany this dysfunction, as well as its possible reversibility with its normalization.- Objectives
- The investigators will essentially have two main objectives:
- Mapping of the most evident symptomatic changes, when sacroiliac joint dysfunction is present, in terms of pain, balance and gait ;
- To try to understand the immediate, global and short-term effect of ASI manipulation, studying the cumulative effect of six sessions and the possible interrelationship between the changes recorded.
- Study design Quantitative, with experimental study design, RCT, with the sample comprising individuals with SIJ dysfunction, where all participants in study 2 will be randomly allocated to the experimental, control and placebo groups. It will be carried out at the University of Aveiro facilities. Initially, the investigators will map the changes present at a physical level, followed by manipulation, evaluating the immediate effect, measuring the degree of pain, unipodal balance and satisfaction with the treatment. The investigators will then evaluate the effect of 3 sessions, on a weekly basis, for 3 weeks.
- Material and methods The investigators will make use of:
- Standing flexion test, to define the laterality of the dysfunction;
- VAS , to subjectively assess pain;
- Pressure algometer, to objectively assess pain ;
- Force Platform, to assess balance;
- G-Walk, for gait assessment;
- PGIC, to assess satisfaction with treatment ;
Detailed description
Procedures to be used in the Experimental Study Material and methods
Reception of participants, with a clear explanation of the objectives and procedures to be used in the pilot study, asking them to fill out:
- an informed consent model; 2. a sociodemographic and health data questionnaire; 3. a participant recruitment form (all of which were previously approved by the Data Protection Officer and the Ethics and Deontology Council of the University of Aveiro); 4. Select the study participants, assessing the presence of Sacroiliac Joint Dysfunction, for which the investigators will use the following procedures, using a multitest assessment, which consists of using a combination of palpation and pain provocation tests, which exhibits sufficient validity and reliability in the diagnosis of sacroiliac joint dysfunction ( Telli et al., 2018); 4. 1 - Bending test in foot - Performed by palpating the posterior superior iliac spine (PSIS) while the person is bending forward from the standing position. The test is negative if PSISs appear to move equally and sym - metrically, or positive on the side in which the PSIS moves crani - ally and ventrally more than the other side. A positive result indicates limited movement of the ilium on the sacrum, and therefore limited SIJ movement on the side of the superior PSIS ( Ribeiro et al, 2021); 4.2 - Bending test sitting - Similar to the standing flexion test, but the persons starts from the sitting position. The test is negative if PSISs appear to move equally and symmetrically, and positive on the side on which the PSIS moves cranially and ventrally more than the other side. A positive result indicates limited movement of the sacrum on the ilium, and therefore limited SIJ movement on the side of the superior PSIS (Ribeiro et al, 2021); 4.3 - Thigh thrust test (POSH) - The patient lies in a supine position. The hip is brought to 90º flexion. Pressure is applied directly toward the examination table. Pathology in the SI joint is considered if pain occurs in the hip. Pain provocation is established with hip flexion and adduction ( Telli et al, 2018); 4.4 - Sacral thrust test - The patient lies in a prone position. The practitioner places one hand on the apex of the sacrum while applying direct pressure with the other hand ( Telli et al, 2018); 4.5 - FABER test - The patient lies in a supine position, while the practitioner stands beside the patient and bends the patient's knee, bringing the heel to the opposite knee. With the other hand, the investigator ensures that the contralateral anterior superior iliac spine remains in a neutral position. The doctor applies mild pressure to the bent knee. Pressure is assumed to be applied to the bilateral sacroiliac ligaments and hip joints. Pain provocation occurs with flexion, abduction and external rotation of the hip ( Telli et al, 2018)
Participants who test positive in at least 4 of the 5 tests mentioned above will be selected to participate in the following studies:
- PHASE 1 Objective : mapping of changes present in selected individuals with SIJ dysfunction, in terms of pain, unipedal static balance and gait;
Variables :
- Pain;
- Static balance;
- Single-leg static balance;
- Gait assessment;
Instruments : -
- Visual Analogue Scale (VAS) , to assess the subjective sensation of pain perceived by the participant;
- Pressure Algometer , to assess pain, used at the following points:
- Lower limbs: muscular belly of the external calves, 8 cm below their origin and muscular belly of the internal calves, 12 cm below the origin, cuboids and tarsal naviculars, external and internal joint interline, middle third, in both knees
- Upper limbs: bilaterally at the level of the muscular belly of the short portion of the biceps brachii, 9 cm above the elbow crease and muscular belly of the long portion of the same muscle, 9 cm above the elbow crease , epicondyle and epitrochlea.
- Cervical spine: At the level of the transverse processes of C4, bilaterally;
- Lumbar spine: At the level of the transverse processes of L3, bilaterally;
- Sacroiliac joints bilaterally, at the level of the posterior superior iliac spine, bilaterally;
- Craniocervical transition, bilaterally, at the level of the occipital origin of the upper trapezius muscle;
- Force platform , to assess single-leg static balance;
- G-Walk, wearable inertial sensor for motion analysis, for gait assessment;
- PHASE 2 Objective : To evaluate the immediate effect of ASI manipulation, assessing the variables at the beginning and end of the first session, regarding pain, balance, gait assessment, overall perception of change and satisfaction with the intervention, with weekly frequency, for 3 weeks.
Clinical trial (RCT), in which participants will be randomly divided into 3 groups:
- Experimental group , subject to manipulation performed by the same Physiotherapist, using the techniques described by Shadmehr, A. et al (2018);
- Sham Group , subjected only to a simulation of manipulation, using the same gestures, but without manipulating, used as a placebo group;
- Control group , which will not be subject to any intervention.
Variables :
- Pain;
- Single-leg static balance;
- Gait assessment;
- Perception of change and satisfaction with treatment.
Instruments:
- VAS, used before and immediately after the intervention ;
- Pressure algometer, evaluating before and immediately after the intervention ;
- Force platform;
- G-Walk, wearable inertial sensor for motion analysis, for gait assessment;
- PGIC , to assess the perception of change and satisfaction with treatment, immediately after the last treatment;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual manipulation | Experimental | Other: Manual ManipulationExperimental group, subject to manipulation performed by the same Physiotherapist, using the techniques described by Shadmehr, A. et al (2018). |
| Sham Manipulation | Sham comparator | Other: Sham ManipulationSham group, subjected only to a simulation of manipulation, using the same gestures, but without manipulating, used as a placebo group. |
| Control Group | No intervention | –Control group, which will not be subject to any intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with sacroiliac joint dysfunction demonstrated
- Students of Aveiro University
- Aged between 18 and 30 years
Key exclusion criteria (2 listed)
- Individuals with neurological injuries
- Subject to another type of therapeutic intervention, during the intervention period.
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 |
|---|---|---|
| Manual ManipulationThe participants will receive one session of manipulation if in the experimental group. It should be mentioned that the technique will be carried out by a physiotherapist with a history of more than 10 years of manual therapy. For instance, to correct right anterior innominate rotation, the participant will be made to lie on the side so that the affected side is upward. The physiotherapist will stand in front of the participant; first we will put their shoulders, pelvis and lower limbs in neutral position and place the right hand on the anterior superior iliac spine (ASIS) and the left hand on the ischium tuberosity and with a rotational movement of the hands, the physiotherapist will rotate the ilium posteriorly. At the end of the range, we will replace the position of hands and place the left forearm on the ischium tuberosity and place the right hand on the upper participant's shoulder and will move it toward the bed at the end of the range in exhalation a thrust will be executed. | Other | Manual manipulation |
| Sham ManipulationThe participants will receive one session of sham manipulation if in the sham group. For instance, to correct right anterior innominate rotation, the participant will be made to lie on the side so that the affected side is upward. The physiotherapist will stand in front of the participant; first we will put their shoulders, pelvis and lower limbs in neutral position and place the right hand on the anterior superior iliac spine (ASIS) and the left hand on the ischium tuberosity and with a rotational movement of the hands, the physiotherapist will rotate the ilium posteriorly. At the end of the range, we will replace the position of hands and place the left forearm on the ischium tuberosity and place the right hand on the upper participant's shoulder and will move it toward the bed at the end of the range in exhalation, the physiotherapist will pretend to execute a thrust. | Other | Sham Manipulation |
Primary outcome
Subjective Pain Assessment
Time frame: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]
Pain will be assessed with the Visual Analogue Scale (VAS), a horizontal line graded 0 (better outcome) to 10 (worse outcome).
Algometry Pain Assessment
Time frame: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week
Pressure algometer
Single-leg balance
Time frame: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]
Assess single-leg balance with a force platform
Gait parameters
Time frame: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week
Assess gait parameters with G-Walk, a wearable inertial sensor for motion analysis
Global perception of change and satisfaction with treatment
Time frame: Immediately after the last treatment
PGIC ( Patient Global Improvement Change Scale ) - is an instrument for measuring and evaluating the global perception of change and satisfaction with treatment, used in any health condition, unidimensional, with a scoring system on a positive orientation scale from 1 to 7, with a completion time of 1 minute*.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Manipulation in people with Sacroiliac Dysfunction, run by Aveiro University at 1 site in Portugal.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Apr 2025. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective Pain Assessment (time frame: From enrollment the assessment will be executed, before and immediately after the intervention taking approximately one week]). The study lists 5 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 9 Apr 2025.