Cervical Disc HerniationNCT07781982
Action Observation and Motor Imagery Training in Cervical Disc Herniation
A study testing Conventional Physiotherapy and Action Observation and Motor Imagery Training in people with Cervical Disc Herniation and Chronic Pain, run by İrem Çetinkaya.
Trial summary
Cervical disc herniation is a common degenerative spinal disorder associated with chronic neck pain, impaired cervical function, reduced motor control, and decreased quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation, Chronic Pain, Kinesiophobia
- What is being tested?
- Conventional Physiotherapy and Action Observation and Motor Imagery Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2026to 1 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years. Diagnosis of cervical radiculopathy confirmed by a physician based on clinical examination and magnetic resonance imaging (MRI).
- History of chronic neck pain lasting at least 3 months. Sufficient active cervical range of motion to participate in the intervention (flexion and extension ≥20°, lateral flexion ≥15°, and rotation ≥30°).
- Neck pain intensity of ≥3 points on the Visual Analog Scale (VAS) and neck disability of ≥10 points on the Neck Disability Index (NDI) at baseline.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Inability to comply with the study protocol or cooperate with study procedures. Cognitive impairment (e.g., dementia or learning disability) that would interfere with understanding or completing the intervention or assessments.
- History of cervical spine surgery. Acute trauma, fracture, tumor, infection, or other serious pathology involving the cervical spine or shoulder region.
- Cervical spinal stenosis, cervical myelopathy, advanced cervical spondylosis, or other significant structural degenerative cervical spine disorders.
- Uncontrolled neurological or systemic disease that could influence study participation or outcomes.
- Receipt of any treatment targeting the cervical region within the previous 6 months (e.g., physiotherapy, injection therapy, or other invasive interventions).
- Visual impairment, hearing impairment, or severe vestibular disorders that would prevent participation in the intervention protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dilan Yaman contact
About this study
Official title: Clinical Effectiveness of Action Observation and Motor Imagery Training in Individuals With Cervical Disc Herniation
Cervical disc herniation is a common degenerative spinal disorder associated with chronic neck pain, impaired cervical function, reduced motor control, and decreased quality of life. Although conventional physiotherapy is widely used, innovative rehabilitation strategies that enhance motor learning may improve treatment outcomes. This randomized controlled trial aims to investigate the clinical effectiveness of Action Observation (AO) and Motor Imagery (MI) training as an adjunct to conventional physiotherapy in individuals with cervical disc herniation and chronic neck pain.
Thirty-six participants diagnosed with cervical disc herniation will be randomly assigned to one of two groups. The control group will receive conventional physiotherapy combined with sham observation consisting of neutral nature videos, while the experimental group will receive conventional physiotherapy plus AO and MI training. The intervention period will last six weeks. Clinical outcomes will be assessed before and after the intervention. Primary and secondary outcome measures will include pain intensity, pressure pain threshold, neck disability, kinesiophobia, cervical motor control and endurance, and cervical proprioception using validated assessment tools.
The findings of this study are expected to provide evidence regarding the effectiveness of AO and MI training as complementary rehabilitation approaches for individuals with cervical disc herniation and to support the integration of motor learning-based interventions into clinical physiotherapy practice.
Read the detailed description
The cervical spine is highly susceptible to mechanical stress and degenerative changes because of its considerable mobility. Degenerative alterations may lead to cervical disc herniation, a condition commonly associated with chronic neck pain, restricted cervical mobility, impaired function, and reduced quality of life. In addition to peripheral musculoskeletal impairments, chronic neck pain has been associated with changes in central nervous system processing, including alterations in proprioception, motor control, muscle activation, and cortical organization.
Action Observation (AO) and Motor Imagery (MI) are non-invasive, low-cost, motor learning-based rehabilitation approaches that target the central nervous system. Motor imagery involves the mental rehearsal of a movement without physical execution, whereas action observation consists of observing goal-directed movements to facilitate activation of motor-related cortical networks. Both approaches are believed to enhance neuroplasticity and improve motor performance by promoting cortical excitability and motor learning.
Previous studies have reported beneficial effects of AO and MI on pain, proprioception, motor control, and functional performance in individuals with musculoskeletal disorders. However, evidence regarding the combined application of AO and MI in individuals with cervical disc herniation remains limited, particularly in randomized controlled trials incorporating a sham intervention. The inclusion of a sham observation group using neutral nature videos is intended to distinguish the specific therapeutic effects of AO and MI from nonspecific effects related to attention and treatment participation.
The present study is designed as a randomized controlled trial to investigate the clinical effectiveness of AO and MI training as an adjunct to conventional physiotherapy in individuals with cervical disc herniation and chronic neck pain. Thirty-six participants will be randomly assigned to one of two groups. The control group will receive conventional physiotherapy combined with sham observation consisting of neutral nature videos, whereas the experimental group will receive conventional physiotherapy in addition to AO and MI training. The intervention period will last six weeks.
Clinical outcomes will be evaluated before and after the intervention. Outcome measures will include pain intensity, pressure pain threshold, neck-related disability, kinesiophobia, cervical proprioception, cervical motor control, and muscular endurance using validated assessment tools. The primary objective is to determine whether the addition of AO and MI training provides greater improvements in these clinical outcomes than conventional physiotherapy with sham observation. The findings are expected to contribute to the evidence supporting motor learning-based rehabilitation strategies and to facilitate the integration of neuroplasticity-oriented interventions into the conservative management of cervical disc herniation.
- Conditions
- Cervical Disc Herniation, Chronic Pain, Kinesiophobia, Cervical Pain
- Being tested
- Conventional Physiotherapy, Action Observation and Motor Imagery Training, Sham Observation
- Keywords
- Cervical disc herniation, Motor imagery, Action observation, chronic pain, kinesiophobia, function
- Medical subject headings
- Chronic Pain, Kinesiophobia, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
Participants in both study groups will receive an individualized conventional physiotherapy program three times per week for six weeks. The program will include electrotherapy (conventional transcutaneous electrical nerve stimulation or vacuum interferential current applied on alternating sessions), superficial heat therapy, soft tissue mobilization, and a supervised therapeutic exercise program. The exercise program will consist of deep cervical flexor activation exercises, cervical range-of-motion exercises, scapular stabilization exercises, postural correction exercises, and stretching exercises targeting the upper trapezius, levator scapulae, and pectoral muscles. All treatment sessions will be delivered individually by the same physiotherapist, and exercise intensity will be adjusted according to each participant's tolerance and clinical status.
Action Observation and Motor Imagery TrainingOther
Participants in the experimental group will receive approximately 20 minutes of Action Observation (AO) and Motor Imagery (MI) training in addition to conventional physiotherapy during each treatment session, three times per week for six weeks. During the AO component, participants will observe standardized videos demonstrating correct execution of cervical and scapular movements, including cervical flexion, extension, lateral flexion, rotation, and scapular retraction. Immediately afterward, participants will perform MI under physiotherapist supervision by mentally rehearsing the same movements using both visual imagery (imagining observing themselves performing the movement) and kinesthetic imagery (imagining the sensory experience of performing the movement). All sessions will be delivered individually following a standardized intervention protocol.
Sham ObservationOther
Participants in the control group will receive approximately 20 minutes of sham observation in addition to conventional physiotherapy during each treatment session, three times per week for six weeks. Instead of Action Observation and Motor Imagery training, participants will watch neutral nature videos without any human movement or motor-related content. The sham intervention is designed to match the experimental intervention in duration, therapist supervision, and attention while avoiding activation of motor learning processes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will receive an individualized conventional physiotherapy program three times per week for six weeks. In addition, they will receive approximately 20 minutes of Action Observation (AO) and Motor Imagery (MI) training during each treatment session. Receives: Other: Conventional Physiotherapy; Other: Action Observation and Motor Imagery Training |
| Control Group | Sham comparator | Participants in the control group will receive the same individualized conventional physiotherapy program three times per week for six weeks. In place of Action Observation and Motor Imagery training, they will watch neutral nature videos without motor content for approximately 20 minutes during each session as a sham observation intervention. Receives: Other: Conventional Physiotherapy; Other: Sham Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Neck-related disability will be assessed using the Neck Disability Index (NDI). The NDI consists of 10 items addressing pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, resulting in a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability.
Measured: Baseline and immediately after the 6-week intervention
Craniocervical Flexion Test
Deep cervical flexor motor control and endurance will be assessed using the Craniocervical Flexion Test with a pressure biofeedback unit. Participants will perform progressive craniocervical flexion at five pressure levels (22-30 mmHg) from a baseline pressure of 20 mmHg. The highest pressure level successfully achieved and maintained for 10 seconds without compensatory movement will be recorded as the motor control performance. The participant's ability to sustain the target pressure level throughout the test will also be used to evaluate deep cervical flexor muscle endurance. Higher performance reflects better motor control and endurance.
Measured: Baseline and immediately after the 6-week intervention
Secondary outcomes (4)
Visual Analog Scale for Pain
Neck pain intensity will be assessed using a 10-cm Visual Analog Scale. Participants will mark their perceived pain intensity on a horizontal line ranging from 0, indicating no pain, to 10, indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Baseline and immediately after the 6-week intervention
Pressure Pain Threshold Measured With a Digital Algometer
Pressure pain threshold will be assessed using a digital pressure algometer. Measurements will be performed bilaterally at the level of the C5 vertebra and at the midpoint of the upper trapezius muscle. Pressure will be gradually increased until the participant first reports pain. Three measurements will be obtained from each assessment site, and the mean value will be recorded. Higher values indicate a higher pressure pain threshold and lower mechanical pain sensitivity.
Measured: Baseline and immediately after the 6-week intervention
Tampa Scale for Kinesiophobia-11
Fear of movement will be assessed using the 11-item Tampa Scale for Kinesiophobia (TSK-11). Each item is scored on a 4-point Likert scale, and the total score ranges from 11 to 44. Higher scores indicate greater pain-related fear of movement.
Measured: Baseline and immediately after the 6-week intervention
Cervical Joint Position Error
Cervical proprioception will be assessed using the Laser Pointer Assisted Active Repositioning Test. Participants will perform a cervical movement and then attempt to return their head to the initial neutral position. The difference between the initial and repositioned head positions will be recorded as the absolute joint position error in degrees. Lower error values indicate better cervical proprioceptive accuracy.
Measured: Baseline and immediately after the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İrem Çetinkaya
- Sponsor type
- University, hospital or other
- Collaborators
- Halic University
- Responsible party
- Sponsor-investigator, İrem Çetinkaya, Marmara University
- Investigators
- İrem Çetinkaya, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781982
- Sponsor's protocol ID
- karanki10
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Action Observation and Motor Imagery Training in Individuals With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT07781982
- Acronym / sponsor ID
- karanki10
- Conditions
- Cervical Disc Herniation, Chronic Pain, Kinesiophobia, Cervical Pain
- Keywords
- Cervical disc herniation, Motor imagery, Action observation, chronic pain, kinesiophobia, function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- İrem ÇetinkayaUniversity, hospital or other
- Collaborators
- Halic University
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Aug 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.
Cervical disc herniation is a common degenerative spinal disorder associated with chronic neck pain, impaired cervical function, reduced motor control, and decreased quality of life. Although conventional physiotherapy is widely used, innovative rehabilitation strategies that enhance motor learning may improve treatment outcomes. This randomized controlled trial aims to investigate the clinical effectiveness of Action Observation (AO) and Motor Imagery (MI) training as an adjunct to conventional physiotherapy in individuals with cervical disc herniation and chronic neck pain.
Thirty-six participants diagnosed with cervical disc herniation will be randomly assigned to one of two groups. The control group will receive conventional physiotherapy combined with sham observation consisting of neutral nature videos, while the experimental group will receive conventional physiotherapy plus AO and MI training. The intervention period will last six weeks. Clinical outcomes will be assessed before and after the intervention. Primary and secondary outcome measures will include pain intensity, pressure pain threshold, neck disability, kinesiophobia, cervical motor control and endurance, and cervical proprioception using validated assessment tools.
The findings of this study are expected to provide evidence regarding the effectiveness of AO and MI training as complementary rehabilitation approaches for individuals with cervical disc herniation and to support the integration of motor learning-based interventions into clinical physiotherapy practice.
Detailed description
The cervical spine is highly susceptible to mechanical stress and degenerative changes because of its considerable mobility. Degenerative alterations may lead to cervical disc herniation, a condition commonly associated with chronic neck pain, restricted cervical mobility, impaired function, and reduced quality of life. In addition to peripheral musculoskeletal impairments, chronic neck pain has been associated with changes in central nervous system processing, including alterations in proprioception, motor control, muscle activation, and cortical organization.
Action Observation (AO) and Motor Imagery (MI) are non-invasive, low-cost, motor learning-based rehabilitation approaches that target the central nervous system. Motor imagery involves the mental rehearsal of a movement without physical execution, whereas action observation consists of observing goal-directed movements to facilitate activation of motor-related cortical networks. Both approaches are believed to enhance neuroplasticity and improve motor performance by promoting cortical excitability and motor learning.
Previous studies have reported beneficial effects of AO and MI on pain, proprioception, motor control, and functional performance in individuals with musculoskeletal disorders. However, evidence regarding the combined application of AO and MI in individuals with cervical disc herniation remains limited, particularly in randomized controlled trials incorporating a sham intervention. The inclusion of a sham observation group using neutral nature videos is intended to distinguish the specific therapeutic effects of AO and MI from nonspecific effects related to attention and treatment participation.
The present study is designed as a randomized controlled trial to investigate the clinical effectiveness of AO and MI training as an adjunct to conventional physiotherapy in individuals with cervical disc herniation and chronic neck pain. Thirty-six participants will be randomly assigned to one of two groups. The control group will receive conventional physiotherapy combined with sham observation consisting of neutral nature videos, whereas the experimental group will receive conventional physiotherapy in addition to AO and MI training. The intervention period will last six weeks.
Clinical outcomes will be evaluated before and after the intervention. Outcome measures will include pain intensity, pressure pain threshold, neck-related disability, kinesiophobia, cervical proprioception, cervical motor control, and muscular endurance using validated assessment tools. The primary objective is to determine whether the addition of AO and MI training provides greater improvements in these clinical outcomes than conventional physiotherapy with sham observation. The findings are expected to contribute to the evidence supporting motor learning-based rehabilitation strategies and to facilitate the integration of neuroplasticity-oriented interventions into the conservative management of cervical disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Conventional Physiotherapy, Other: Action Observation and Motor Imagery TrainingParticipants in the experimental group will receive an individualized conventional physiotherapy program three times per week for six weeks. In addition, they will receive approximately 20 minutes of Action Observation (AO) and Motor Imagery (MI) training during each treatment session. |
| Control Group | Sham comparator | Other: Conventional Physiotherapy, Other: Sham ObservationParticipants in the control group will receive the same individualized conventional physiotherapy program three times per week for six weeks. In place of Action Observation and Motor Imagery training, they will watch neutral nature videos without motor content for approximately 20 minutes during each session as a sham observation intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 65 years. Diagnosis of cervical radiculopathy confirmed by a physician based on clinical examination and magnetic resonance imaging (MRI).
- History of chronic neck pain lasting at least 3 months. Sufficient active cervical range of motion to participate in the intervention (flexion and extension ≥20°, lateral flexion ≥15°, and rotation ≥30°).
- Neck pain intensity of ≥3 points on the Visual Analog Scale (VAS) and neck disability of ≥10 points on the Neck Disability Index (NDI) at baseline.
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (6 listed)
- Inability to comply with the study protocol or cooperate with study procedures. Cognitive impairment (e.g., dementia or learning disability) that would interfere with understanding or completing the intervention or assessments.
- History of cervical spine surgery. Acute trauma, fracture, tumor, infection, or other serious pathology involving the cervical spine or shoulder region.
- Cervical spinal stenosis, cervical myelopathy, advanced cervical spondylosis, or other significant structural degenerative cervical spine disorders.
- Uncontrolled neurological or systemic disease that could influence study participation or outcomes.
- Receipt of any treatment targeting the cervical region within the previous 6 months (e.g., physiotherapy, injection therapy, or other invasive interventions).
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 |
|---|---|---|
| Conventional PhysiotherapyParticipants in both study groups will receive an individualized conventional physiotherapy program three times per week for six weeks. The program will include electrotherapy (conventional transcutaneous electrical nerve stimulation or vacuum interferential current applied on alternating sessions), superficial heat therapy, soft tissue mobilization, and a supervised therapeutic exercise program. The exercise program will consist of deep cervical flexor activation exercises, cervical range-of-motion exercises, scapular stabilization exercises, postural correction exercises, and stretching exercises targeting the upper trapezius, levator scapulae, and pectoral muscles. All treatment sessions will be delivered individually by the same physiotherapist, and exercise intensity will be adjusted according to each participant's tolerance and clinical status. | Other | Control Group, Experimental Group |
| Action Observation and Motor Imagery TrainingParticipants in the experimental group will receive approximately 20 minutes of Action Observation (AO) and Motor Imagery (MI) training in addition to conventional physiotherapy during each treatment session, three times per week for six weeks. During the AO component, participants will observe standardized videos demonstrating correct execution of cervical and scapular movements, including cervical flexion, extension, lateral flexion, rotation, and scapular retraction. Immediately afterward, participants will perform MI under physiotherapist supervision by mentally rehearsing the same movements using both visual imagery (imagining observing themselves performing the movement) and kinesthetic imagery (imagining the sensory experience of performing the movement). All sessions will be delivered individually following a standardized intervention protocol. | Other | Experimental Group |
| Sham ObservationParticipants in the control group will receive approximately 20 minutes of sham observation in addition to conventional physiotherapy during each treatment session, three times per week for six weeks. Instead of Action Observation and Motor Imagery training, participants will watch neutral nature videos without any human movement or motor-related content. The sham intervention is designed to match the experimental intervention in duration, therapist supervision, and attention while avoiding activation of motor learning processes. | Other | Control Group |
Primary outcome
Neck Disability Index
Time frame: Baseline and immediately after the 6-week intervention
Neck-related disability will be assessed using the Neck Disability Index (NDI). The NDI consists of 10 items addressing pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, resulting in a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability.
Craniocervical Flexion Test
Time frame: Baseline and immediately after the 6-week intervention
Deep cervical flexor motor control and endurance will be assessed using the Craniocervical Flexion Test with a pressure biofeedback unit. Participants will perform progressive craniocervical flexion at five pressure levels (22-30 mmHg) from a baseline pressure of 20 mmHg. The highest pressure level successfully achieved and maintained for 10 seconds without compensatory movement will be recorded as the motor control performance. The participant's ability to sustain the target pressure level throughout the test will also be used to evaluate deep cervical flexor muscle endurance. Higher performance reflects better motor control and endurance.
4 secondary outcomes
Visual Analog Scale for Pain
Time frame: Baseline and immediately after the 6-week intervention
Pressure Pain Threshold Measured With a Digital Algometer
Time frame: Baseline and immediately after the 6-week intervention
Tampa Scale for Kinesiophobia-11
Time frame: Baseline and immediately after the 6-week intervention
Cervical Joint Position Error
Time frame: Baseline and immediately after the 6-week intervention
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 24 Aug 2026.
- 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.
Dilan Yaman contact
İrem Çetinkaya, PhD principal investigator
Marmara University
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Action Observation and Motor Imagery Training in people with Cervical Disc Herniation and Chronic Pain, run by İrem Çetinkaya.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact İrem Çetinkaya, PhD (5548056805, iremkaranki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: Baseline and immediately after the 6-week intervention). The study lists 2 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 24 Aug 2026.