Suboccipital MusclesNCT06761391
Effects of Suboccipital Release on Sensorial and Functional Parameters
A study testing Pain Pressure Threshold, Cervical Range of Motion and Balance Error Scoring in people with Suboccipital Muscles, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Suboccipital release is a straightforward technique beneficial for addressing musculoskeletal complaints like neck pain and headaches. This versatile method aids the autonomic system by manipulating the occipital-atlanto region, specifically regulating the parasympathetic system rather than the sympathetic system… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Suboccipital Muscles
- What is being tested?
- Pain Pressure Threshold, Cervical Range of Motion and Balance Error Scoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2024to 2 Oct 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers willing to participate in the study.
Who cannot join
- Diagnosed with an upper extremity musculoskeletal system disease. Experiencing chronic headaches or migraine complaints. Presence of any pathology causing sensory or balance impairments. Diagnosed with a pathology in the cervical regio
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Suboccipital Myofascial Release on Pain Pressure Threshold, Range of Motion, Balance, and Proprioception
Suboccipital release is a straightforward technique beneficial for addressing musculoskeletal complaints like neck pain and headaches. This versatile method aids the autonomic system by manipulating the occipital-atlanto region, specifically regulating the parasympathetic system rather than the sympathetic system targeted by most osteopathic treatments. Studies indicate this technique enhances range of motion and balance in the lower extremities of both healthy and pre-existing patients due to fascia connections throughout the body. Suboccipital muscle release increases cervical spine range of motion, facilitating physical therapy. Myofascial release significantly boosts joint flexibility and range of motion (ROM) without reducing strength or performance. The rectus capitus posterior minor (RCPM) muscle, dense with spindles, is crucial in the suboccipital region for balance and pain proprioception. Trauma-induced atrophy in this muscle is strongly linked to chronic neck pain and reduced standing balance. A case report showed that a patient undergoing a personalized balance program exhibited significant balance improvement, suggesting that balance training should be considered for cervicogenic pain intervention strategies. Neck muscle spasms or fatigue can impair proprioception and postural control, with prolonged unilateral cervical muscle contraction increasing neck proprioceptor sensitivity. Muscle fatigue-related interstitial inflammatory mediators can sensitize muscle spindles. This study will explore suboccipital relaxation's acute effects on pressure pain threshold, range of motion, balance, and joint position sense in healthy individuals based on existing literature.
Read the detailed description
Suboccipital release is a relatively easy technique that a person can use to help with musculoskeletal complaints such as neck pain and headaches. This technique is also very versatile and can help regulate the autonomic system in the body due to the manipulation of the occipital-atlanto region. This technique has been noted to regulate the parasympathetic system rather than the sympathetic system that most osteopathic treatments target. Studies have shown that this technique improves range of motion and balance in the lower extremities of healthy and pre-existing patients due to the connection of the fascia throughout the body. The release of the suboccipital muscles increases the range of motion of the cervical spine, which makes it easier for the physical therapist. Myofascial release has been shown to significantly increase joint flexibility and range of motion (ROM) without causing any loss of strength or decreased performance . Studies on the rectus capitus posterior minor (RCPM) muscle indicate that it is one of the most important muscles in the suboccipital region. Because of the high density of muscle spindles, it is presumed that this muscle plays a role as a proprioceptive monitor important for balance and pain. Trauma has been shown to cause atrophy in this muscle, and this atrophy is strongly associated with chronic neck pain and decreased standing balance (4). A case report has shown that a patient who underwent a personalized balance program showed significant improvement in balance as measured by sensory organization testing; this improved balance control suggests that balance training should be considered when determining appropriate intervention strategies for patients with cervicogenic pain. Neck muscle spasms or fatigue can alter proprioception and postural control, and prolonged contraction of unilateral cervical muscles can significantly increase the sensitivity of neck proprioceptors. Interstitial inflammatory mediators produced by muscle fatigue can sensitize muscle spindles. The acute effects of suboccipital relaxation on pressure pain threshold, range of motion, balance, and joint position sense in healthy individuals have been examined in the literature.
- Conditions
- Suboccipital Muscles
- Being tested
- Pain Pressure Threshold, Cervical Range of Motion, Balance Error Scoring, Cervical Joint Position Sense, Suboccipital manual therapy
- Keywords
- suboccipital release, neck proprioception, pain pressure threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Pressure ThresholdDiagnostic test
A hand-held pressure algometer will be used to record the pressure pain threshold (PPT), defined as the level at which gradually increasing pressure becomes painful. Pressure algometry has shown high intratest reliability in asymptomatic individuals over the suboccipital area and upper trapezius. PPT levels will be measured bilaterally over the neck angle over the middle of the anterior surface of the upper trapezius; and over the rectus capitis posterior major (RCPM) muscle. The physiotherapist will use an increasing pressure of approximately 1 kg/cm²/s. The average of three measurements with a 30-second rest period will be taken for analysis. Two measurements will be taken, before and after.
Cervical Range of MotionDiagnostic test
The degrees obtained as a result of the Range of Motion (ROM) measurements are made with a universal manual goniometer. Goniometer is still the most commonly used method for ROM measurements. For all ROM measurements to be performed, the necessary measurements can be taken based on the American Academy of Orthopaedic Surgeons (AAOS) guidelines . The flexion, extension, right and left rotation angles of the cervical region will be measured and recorded with the goniometer in the sitting position of the person. The measurement will be made twice, before and after the application.
Balance Error ScoringDiagnostic test
Balance performance will be assessed using the Balance Error Scoring System (BESS), known in Turkish as DHPS. Subjects must maintain test positions for 20 seconds under 6 conditions with eyes closed and no support: 2 surfaces (flat and foam) and 3 stance positions (double-foot, single-foot, tandem). A laboratory floor will serve as the flat surface, and an exercise mat will serve as the foam surface. All subjects will perform the conditions in this sequence: double-foot flat, single-foot flat, tandem flat, double-foot foam, single-foot foam, tandem foam, both pre-test and post-test. Each 20-second period will be timed with a stopwatch, and each error within this period will count as 1 point. Each test condition has a maximum error score of 10. Errors include:
- Lifting hands above the iliac crest,
- Opening eyes,
- Taking a step,staggering, falling,
- Flexing or abducting the hip joint beyond 30°,
- Lifting the forefoot or heel off the ground,
- Leaving the test position
Cervical Joint Position SenseDiagnostic test
The sense of joint position in the cervical region will be evaluated in four positions: flexion, extension, right rotation, and left rotation, using a goniometer. Participants will sit upright with arms at their sides, looking ahead. The physiotherapist will passively move the participant's head to 65% of the maximum joint range of motion, previously determined, minimizing vestibular function effects. After holding the head in position for three seconds, participants will be asked to remember the position. Subsequently, they will be instructed to return their head to the neutral position and then actively move it to the previously determined point. The degree of error between the target and achieved positions will be measured.
Suboccipital manual therapyOther
The procedure will be conducted with the patient lying on their back. The practitioner will be seated on a stool at the top of the examination table, their forearm in contact with the surface. After locating the occipital condyles through palpation, the practitioner will position their fingers in the slightly concave region between the occiput and the second cervical vertebra's spinous process. The patient's head will be gently elevated by the practitioner flexing their metacarpophalangeal joints. With the patient's skull base resting in the practitioner's palm, pressure equivalent to the weight of the patient's head will be applied to the rectus capitis posterior and obliquus capitis superior muscles using the practitioner's second, third, and fourth fingers for a duration of 5 minutes. To prevent eye movements from influencing suboccipital muscle tone, patients will be instructed to keep their eyes closed during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital Myofascial Release | Experimental | The application will be done in the supine position. The therapist will sit on the stool at the head of the stretcher with his/her forearm in contact with the stretcher. After palpating the occiput condyles with his/her fingers, the therapist will place his/her fingers in the slightly concave area between the occiput and the spinous process of the second cervical vertebra. The therapist will lift the participant's head a little by bending the metacarpophalangeal joints. While the base of the participant's skull is in the therapist's palm, the therapist will apply pressure equal to the weight of the participant's head with his/her second, third and fourth fingers on the participant's rectus capitis posterior and obliqus capitis superior muscles for 5 minutes. In order for eye movements not to affect the suboccipital muscle tone, the participants will be asked to close their eyes during the application. Receives: Diagnostic Test: Pain Pressure Threshold; Diagnostic Test: Cervical Range of Motion; Diagnostic Test: Balance Error Scoring; Diagnostic Test: Cervical Joint Position Sense; Other: Suboccipital manual therapy |
| Suboccipital Hold | Sham comparator | No suboccipital relaxation will be applied to the control group, and the experimental group will be kept in contact with the suboccipital region for the same period of time, namely 5 minutes, and the measurements will be recorded before and after the application. Receives: Diagnostic Test: Pain Pressure Threshold; Diagnostic Test: Cervical Range of Motion; Diagnostic Test: Balance Error Scoring; Diagnostic Test: Cervical Joint Position Sense; Other: Suboccipital manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Proprioception
Cervical Joint Position Sense Assessment was performed with the Reposition Test using a goniometer.
Measured: Change from baseline to final examination immediate after 5 minutes of manual therapy
Secondary outcomes (3)
Pain Pressure Threshold
Pain pressure threshold of the upper trapezius and rectus capitis muscles was measured with a handheld algometer
Measured: Change from baseline to final examination immediate after 5 minutes of manual therapy
Range of Motion
A goniometer was utilized to assess the range of motion for cervical flexion, extension, and rotation.
Measured: Change from baseline to final examination immediate after 5 minutes of manual therapy
Balance Error Scoring
Balance Error Scoring System was used to measure balance performances.
Measured: Change from baseline to final examination immediate after 5 minutes of manual therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start2 Jun 2024
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suboccipital MusclesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761391
- Sponsor's protocol ID
- Bvu1903
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Safran E, Kaya Y. Contextual and placebo effects of suboccipital myofascial release: evaluating its influence on pain threshold, cervical range of motion, and proprioception. BMC Musculoskelet Disord. 2025 May 21;26(1):502. doi: 10.1186/s12891-025-08741-6.
PubMed 40399920
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Suboccipital Myofascial Release on Pain Pressure Threshold, Range of Motion, Balance, and Proprioception
- ClinicalTrials.gov ID
- NCT06761391
- Acronym / sponsor ID
- Bvu1903
- Conditions
- Suboccipital Muscles
- Keywords
- suboccipital release, neck proprioception, pain pressure threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 7 Jan 2025 (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.
Suboccipital release is a straightforward technique beneficial for addressing musculoskeletal complaints like neck pain and headaches. This versatile method aids the autonomic system by manipulating the occipital-atlanto region, specifically regulating the parasympathetic system rather than the sympathetic system targeted by most osteopathic treatments. Studies indicate this technique enhances range of motion and balance in the lower extremities of both healthy and pre-existing patients due to fascia connections throughout the body. Suboccipital muscle release increases cervical spine range of motion, facilitating physical therapy. Myofascial release significantly boosts joint flexibility and range of motion (ROM) without reducing strength or performance. The rectus capitus posterior minor (RCPM) muscle, dense with spindles, is crucial in the suboccipital region for balance and pain proprioception. Trauma-induced atrophy in this muscle is strongly linked to chronic neck pain and reduced standing balance. A case report showed that a patient undergoing a personalized balance program exhibited significant balance improvement, suggesting that balance training should be considered for cervicogenic pain intervention strategies. Neck muscle spasms or fatigue can impair proprioception and postural control, with prolonged unilateral cervical muscle contraction increasing neck proprioceptor sensitivity. Muscle fatigue-related interstitial inflammatory mediators can sensitize muscle spindles. This study will explore suboccipital relaxation's acute effects on pressure pain threshold, range of motion, balance, and joint position sense in healthy individuals based on existing literature.
Detailed description
Suboccipital release is a relatively easy technique that a person can use to help with musculoskeletal complaints such as neck pain and headaches. This technique is also very versatile and can help regulate the autonomic system in the body due to the manipulation of the occipital-atlanto region. This technique has been noted to regulate the parasympathetic system rather than the sympathetic system that most osteopathic treatments target. Studies have shown that this technique improves range of motion and balance in the lower extremities of healthy and pre-existing patients due to the connection of the fascia throughout the body. The release of the suboccipital muscles increases the range of motion of the cervical spine, which makes it easier for the physical therapist. Myofascial release has been shown to significantly increase joint flexibility and range of motion (ROM) without causing any loss of strength or decreased performance . Studies on the rectus capitus posterior minor (RCPM) muscle indicate that it is one of the most important muscles in the suboccipital region. Because of the high density of muscle spindles, it is presumed that this muscle plays a role as a proprioceptive monitor important for balance and pain. Trauma has been shown to cause atrophy in this muscle, and this atrophy is strongly associated with chronic neck pain and decreased standing balance (4). A case report has shown that a patient who underwent a personalized balance program showed significant improvement in balance as measured by sensory organization testing; this improved balance control suggests that balance training should be considered when determining appropriate intervention strategies for patients with cervicogenic pain. Neck muscle spasms or fatigue can alter proprioception and postural control, and prolonged contraction of unilateral cervical muscles can significantly increase the sensitivity of neck proprioceptors. Interstitial inflammatory mediators produced by muscle fatigue can sensitize muscle spindles. The acute effects of suboccipital relaxation on pressure pain threshold, range of motion, balance, and joint position sense in healthy individuals have been examined in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboccipital Myofascial Release | Experimental | Diagnostic Test: Pain Pressure Threshold, Diagnostic Test: Cervical Range of Motion, Diagnostic Test: Balance Error Scoring, Diagnostic Test: Cervical Joint Position Sense, Other: Suboccipital manual therapyThe application will be done in the supine position. The therapist will sit on the stool at the head of the stretcher with his/her forearm in contact with the stretcher. After palpating the occiput condyles with his/her fingers, the therapist will place his/her fingers in the slightly concave area between the occiput and the spinous process of the second cervical vertebra. The therapist will lift the participant's head a little by bending the metacarpophalangeal joints. While the base of the participant's skull is in the therapist's palm, the therapist will apply pressure equal to the weight of the participant's head with his/her second, third and fourth fingers on the participant's rectus capitis posterior and obliqus capitis superior muscles for 5 minutes. In order for eye movements not to affect the suboccipital muscle tone, the participants will be asked to close their eyes during the application. |
| Suboccipital Hold | Sham comparator | Diagnostic Test: Pain Pressure Threshold, Diagnostic Test: Cervical Range of Motion, Diagnostic Test: Balance Error Scoring, Diagnostic Test: Cervical Joint Position Sense, Other: Suboccipital manual therapyNo suboccipital relaxation will be applied to the control group, and the experimental group will be kept in contact with the suboccipital region for the same period of time, namely 5 minutes, and the measurements will be recorded before and after the application. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers willing to participate in the study.
Key exclusion criteria (1 listed)
- Diagnosed with an upper extremity musculoskeletal system disease. Experiencing chronic headaches or migraine complaints. Presence of any pathology causing sensory or balance impairments. Diagnosed with a pathology in the cervical regio
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 |
|---|---|---|
| Pain Pressure ThresholdA hand-held pressure algometer will be used to record the pressure pain threshold (PPT), defined as the level at which gradually increasing pressure becomes painful. Pressure algometry has shown high intratest reliability in asymptomatic individuals over the suboccipital area and upper trapezius. PPT levels will be measured bilaterally over the neck angle over the middle of the anterior surface of the upper trapezius; and over the rectus capitis posterior major (RCPM) muscle. The physiotherapist will use an increasing pressure of approximately 1 kg/cm²/s. The average of three measurements with a 30-second rest period will be taken for analysis. Two measurements will be taken, before and after. | Diagnostic test | Suboccipital Hold, Suboccipital Myofascial Release |
| Cervical Range of MotionThe degrees obtained as a result of the Range of Motion (ROM) measurements are made with a universal manual goniometer. Goniometer is still the most commonly used method for ROM measurements. For all ROM measurements to be performed, the necessary measurements can be taken based on the American Academy of Orthopaedic Surgeons (AAOS) guidelines . The flexion, extension, right and left rotation angles of the cervical region will be measured and recorded with the goniometer in the sitting position of the person. The measurement will be made twice, before and after the application. | Diagnostic test | Suboccipital Hold, Suboccipital Myofascial Release |
| Balance Error ScoringBalance performance will be assessed using the Balance Error Scoring System (BESS), known in Turkish as DHPS. Subjects must maintain test positions for 20 seconds under 6 conditions with eyes closed and no support: 2 surfaces (flat and foam) and 3 stance positions (double-foot, single-foot, tandem). A laboratory floor will serve as the flat surface, and an exercise mat will serve as the foam surface. All subjects will perform the conditions in this sequence: double-foot flat, single-foot flat, tandem flat, double-foot foam, single-foot foam, tandem foam, both pre-test and post-test. Each 20-second period will be timed with a stopwatch, and each error within this period will count as 1 point. Each test condition has a maximum error score of 10. Errors include: 1. Lifting hands above the iliac crest, 2. Opening eyes, 3. Taking a step,staggering, falling, 4. Flexing or abducting the hip joint beyond 30°, 5. Lifting the forefoot or heel off the ground, 6. Leaving the test position | Diagnostic test | Suboccipital Hold, Suboccipital Myofascial Release |
| Cervical Joint Position SenseThe sense of joint position in the cervical region will be evaluated in four positions: flexion, extension, right rotation, and left rotation, using a goniometer. Participants will sit upright with arms at their sides, looking ahead. The physiotherapist will passively move the participant's head to 65% of the maximum joint range of motion, previously determined, minimizing vestibular function effects. After holding the head in position for three seconds, participants will be asked to remember the position. Subsequently, they will be instructed to return their head to the neutral position and then actively move it to the previously determined point. The degree of error between the target and achieved positions will be measured. | Diagnostic test | Suboccipital Hold, Suboccipital Myofascial Release |
| Suboccipital manual therapyThe procedure will be conducted with the patient lying on their back. The practitioner will be seated on a stool at the top of the examination table, their forearm in contact with the surface. After locating the occipital condyles through palpation, the practitioner will position their fingers in the slightly concave region between the occiput and the second cervical vertebra's spinous process. The patient's head will be gently elevated by the practitioner flexing their metacarpophalangeal joints. With the patient's skull base resting in the practitioner's palm, pressure equivalent to the weight of the patient's head will be applied to the rectus capitis posterior and obliquus capitis superior muscles using the practitioner's second, third, and fourth fingers for a duration of 5 minutes. To prevent eye movements from influencing suboccipital muscle tone, patients will be instructed to keep their eyes closed during the procedure. | Other | Suboccipital Hold, Suboccipital Myofascial Release |
Primary outcome
Neck Proprioception
Time frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
Cervical Joint Position Sense Assessment was performed with the Reposition Test using a goniometer.
3 secondary outcomes
Pain Pressure Threshold
Time frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
Range of Motion
Time frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
Balance Error Scoring
Time frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
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 7 Jan 2025.
- Derived from this study: PubMed 40399920Safran E, Kaya Y. Contextual and placebo effects of suboccipital myofascial release: evaluating its influence on pain threshold, cervical range of motion, and proprioception. BMC Musculoskelet Disord. 2025 May 21;26(1):502. doi: 10.1186/s12891-025-08741-6.
- Individual participant dataSharing planned: No
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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 Pain Pressure Threshold, Cervical Range of Motion and Balance Error Scoring in people with Suboccipital Muscles, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 7 Jan 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 Turkey (Türkiye). 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?
Neck Proprioception (time frame: Change from baseline to final examination immediate after 5 minutes of manual therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761391, which also lists 1 linked publication.
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 7 Jan 2025.