Carpal Tunnel SyndromePhase 4NCT05475808
Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
A Phase 4 study testing Static wrist splint treatment, Tendon and nerve gliding exercises and Wrist local steroid injection in people with Carpal Tunnel Syndrome, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Static wrist splint treatment, Tendon and nerve gliding exercises and Wrist local steroid injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 27 May 2025
- Phase
- Phase 4
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderate CTS confirmed by Electromyography
- Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present.
- Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present.
Who cannot join
- Having a history of trauma and operation on the wrist.
- Patients who have had previous injections from the wrist
- Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
Read the detailed description
Carpal tunnel syndrome (CTS) is one of the most common entrapment neuropathies. It occurs as a result of compression or irritation of the median nerve as it passes through the carpal tunnel in the wrist. It is seen in 1-4% of the general population.In nerve conduction studies, patients with mild and moderate CTS are treated with conservative treatment methods, while patients with severe nerve conduction findings and thenar atrophy are treated surgically.Although there are many methods used in the conservative treatment of carpal tunnel syndrome, there is no definite data about which treatment option to choose.The most commonly used conservative method is the wrist rest splint application, which is based on the principle of resting the wrist.In addition, there are tendon and nerve gliding exercises that facilitate nerve and tendon movements. Physical therapy agents such as Tens, Laser and Ultrasound can be used in the treatment of CTS. Non-Steroidal anti-inflammatory drugs and B6 vitamins can be used as drug therapy. Apart from these, local corticosteroid injections can be applied from the wrist.
There are studies comparing conservative treatment methods in carpal tunnel syndrome. However, these are generally in the form of studies that measure and compare the effects of treatments on the clinical condition of their patients and on hand grip and finger pinch strength. There is no comparative study investigating the effects of conservative treatment methods on wrist muscle strength in patients with carpal tunnel syndrome.
It was observed that wrist muscle strength decreased in patients with CTS compared to normal patients. Wrist muscle strength is important in hand and wrist functions as well as hand grip and pinch strength are important.
Flexion-extension, radial-ulnar deviation and supination-pronation muscle strengths of the patients' wrists can be measured with an isokinetic dynamometer device.
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
It will be organized as a prospective randomized study. It is planned to include 60 patients in the study. Patients will be randomized into three groups in equal numbers, stratified by age and sex.
Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.
Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week .
Patients in Group 3 will be applied to local steroid injection the wrist in addition to static wrist splint treatment for 8 week.
Demographic data, medical history, dominant and CTS hand information will be recorded at the beginning of the patients.
Patients in both groups will be evaluated before the treatment, at the 8th week after treatment.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Static wrist splint treatment, Tendon and nerve gliding exercises, Wrist local steroid injection
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static wrist splint treatmentDevice
Static wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks.
Tendon and nerve gliding exercisesOther
Tendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position.
These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding).
Wrist local steroid injectionDrug
Wrist local steroid injection:
After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Splint | Active comparator | Patients in Group 1 will be applied to only static wrist splint treatment for 8 week. Receives: Device: Static wrist splint treatment |
| Tendon and nerve gliding exercise | Active comparator | Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week. Receives: Device: Static wrist splint treatment; Other: Tendon and nerve gliding exercises |
| local steroid injection | Active comparator | Patients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week. Receives: Device: Static wrist splint treatment; Drug: Wrist local steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Measured: Before Treatment
Visual Analogue Scale
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Measured: 8 week after treatment
Isokinetic Muscle Strength Measure
Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.
Measured: Before Treatment
Isokinetic Muscle Strength Measure
Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.
Measured: 8 week after treatment
The hand grip strength
The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.
Measured: Before Treatment
The hand grip strength
The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.
Measured: 8 week after treatment
The finger pinch strength
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Measured: Before Treatment
The finger pinch strength
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Measured: 8 week after treatment
Boston Carpal Tunnel Syndrome Questionnaire
This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.
Measured: Before Treatment
Boston Carpal Tunnel Syndrome Questionnaire
This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.
Measured: 8 week after treatment
Secondary outcomes (4)
Disabilities of the Arm, Shoulder end Hand Questionnaire
The Disabilities of the Arm, Shoulder end Hand Questionnaire (DASH) consists of 3 parts: the functional/symptom model, the business model, and the sports/musicians model. The individual fills himself. In this study, functional/symptom and business model sections will be used. A score between 0-100 is obtained from each section. High score increases handicap.
Measured: Before Treatment
Disabilities of the Arm, Shoulder end Hand Questionnaire
The Disabilities of the Arm, Shoulder end Hand Questionnaire (DASH) consists of 3 parts: the functional/symptom model, the business model, and the sports/musicians model. The individual fills himself. In this study, functional/symptom and business model sections will be used. A score between 0-100 is obtained from each section. High score increases handicap.
Measured: 8 week after treatment
Short Form-36 Quality of Life Scale
The patients' quality of life will be evaluated with the Short Form-36 Quality of Life Scale. It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Measured: Before Treatment
Short Form-36 Quality of Life Scale
The patients' quality of life will be evaluated with the Short Form-36 Quality of Life Scale. It consists of 36 questions filled by the individual himself. High scores indicate good quality of life.
Measured: 8 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Jul 2023
- Study completion27 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serdar Kilinc, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475808
- Sponsor's protocol ID
- AIBU-FTR-SK-02
- Status last verified
- Feb 2025
- First submitted
- 25 Jul 2022
- Last updated
- 27 Feb 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Different Treatment Methods in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05475808
- Acronym / sponsor ID
- AIBU-FTR-SK-02
- Conditions
- Carpal Tunnel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 27 May 2025 (estimated)
- First posted
- 27 Jul 2022 (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.
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
Detailed description
Carpal tunnel syndrome (CTS) is one of the most common entrapment neuropathies. It occurs as a result of compression or irritation of the median nerve as it passes through the carpal tunnel in the wrist. It is seen in 1-4% of the general population.In nerve conduction studies, patients with mild and moderate CTS are treated with conservative treatment methods, while patients with severe nerve conduction findings and thenar atrophy are treated surgically.Although there are many methods used in the conservative treatment of carpal tunnel syndrome, there is no definite data about which treatment option to choose.The most commonly used conservative method is the wrist rest splint application, which is based on the principle of resting the wrist.In addition, there are tendon and nerve gliding exercises that facilitate nerve and tendon movements. Physical therapy agents such as Tens, Laser and Ultrasound can be used in the treatment of CTS. Non-Steroidal anti-inflammatory drugs and B6 vitamins can be used as drug therapy. Apart from these, local corticosteroid injections can be applied from the wrist.
There are studies comparing conservative treatment methods in carpal tunnel syndrome. However, these are generally in the form of studies that measure and compare the effects of treatments on the clinical condition of their patients and on hand grip and finger pinch strength. There is no comparative study investigating the effects of conservative treatment methods on wrist muscle strength in patients with carpal tunnel syndrome.
It was observed that wrist muscle strength decreased in patients with CTS compared to normal patients. Wrist muscle strength is important in hand and wrist functions as well as hand grip and pinch strength are important.
Flexion-extension, radial-ulnar deviation and supination-pronation muscle strengths of the patients' wrists can be measured with an isokinetic dynamometer device.
It is aimed to compare the effects of different conservative methods on the clinical condition of the patients, hand grip and pinch strengths and wrist muscle strengths in patients with carpal tunnel syndrome.
It will be organized as a prospective randomized study. It is planned to include 60 patients in the study. Patients will be randomized into three groups in equal numbers, stratified by age and sex.
Patients in Group 1 will be applied to only static wrist splint treatment for 8 week.
Patients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week .
Patients in Group 3 will be applied to local steroid injection the wrist in addition to static wrist splint treatment for 8 week.
Demographic data, medical history, dominant and CTS hand information will be recorded at the beginning of the patients.
Patients in both groups will be evaluated before the treatment, at the 8th week after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Splint | Active comparator | Device: Static wrist splint treatmentPatients in Group 1 will be applied to only static wrist splint treatment for 8 week. |
| Tendon and nerve gliding exercise | Active comparator | Device: Static wrist splint treatment, Other: Tendon and nerve gliding exercisesPatients in Group 2 will be applied to tendon and nerve gliding exercises for the wrist in addition to static wrist splint treatment for 8 week. |
| local steroid injection | Active comparator | Device: Static wrist splint treatment, Drug: Wrist local steroid injectionPatients in Group 3 will be applied to local steroid injection to wrist in addition to static wrist splint treatment for 8 week. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with mild to moderate CTS confirmed by Electromyography
- Clinically, at least one of the symptoms of hand-wrist pain, numbness, night pain should be present.
- Clinically, at least one of the Tinel, Phalen, and median nerve compression findings should be present.
Key exclusion criteria (4 listed)
- Having a history of trauma and operation on the wrist.
- Patients who have had previous injections from the wrist
- Patients with thyroid diseases, diabetes mellitus, systemic peripheral neuropathy and cervical radiculopathy
- Pregnant patients
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 |
|---|---|---|
| Static wrist splint treatmentStatic wrist splint (volar wrist cock-up orthosis): It extends from the proximal of the metacarpophalangeal (MCP) joint to the distal 2/3 of the forearm, supports the wrist from the volar face. It stabilizes the wrist in 20-30 degrees of dorsiflexion and restricts wrist movements. It allows movement of the MCP joints. Patients will be asked to wear this splint continuously at night and for at least 4 hours during the day for 8 weeks. | Device | Splint, Tendon and nerve gliding exercise, local steroid injection |
| Tendon and nerve gliding exercisesTendon and nerve gliding exercises will be applied 5 sessions a day for 8 weeks. Each session will hold 10 repetitions and approximately 7 seconds in each exercise position. These exercises involve a sequence of finger movements (for tendon gliding) and wrist and fingers movements (for median nerve gliding). | Other | Tendon and nerve gliding exercise |
| Wrist local steroid injectionWrist local steroid injection: After proper area cleaning with povidone solution, 1ml Betamethasone dipropionate + Betamethasone sodium phosphate (6.43 mg/ml + 2.63 mg/ml) steroid injection will be applied around the median nerve with a 22 G injector from ulnar side of the wrist proximal crease under ultrasound guidance. | Drug | local steroid injection |
Primary outcome
Visual Analogue Scale
Time frame: Before Treatment
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Visual Analogue Scale
Time frame: 8 week after treatment
Pain was evaluated using a 10 cm long Visual Analogue Scale (VAS) during rest and activity (0 = no pain, 10 = very severe pain).
Isokinetic Muscle Strength Measure
Time frame: Before Treatment
Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.
Isokinetic Muscle Strength Measure
Time frame: 8 week after treatment
Wrist flexion/extension, radial/ulnar deviation, supination/pronation strengths at 60° and 210°/s will be evaluated with an isokinetic test and exercise system (CSMI Cybex). Patients will be seated on the test chair with the backrest set to 90°. The arm to be tested will be secured to the chair's forearm rest. The wrist joint will be positioned in neutral. The forearm stabilizer pad and strap will secure the distal aspect of the forearm of the test hand. Wrist flexion/extension range of motion, radial/ulnar deviation range of motion, supination/pronation range of motion will be set within each patients' available range. Patients will be permitted 4 experimental trials to become familiar with the process for each angular velocity, and then they will perform 5 maximal repetitions at 60°/s and 12 maximal repetitions at 210°/s. At the end of the test, muscle strength (Peak Torque) will be measured in Newton meters.
The hand grip strength
Time frame: Before Treatment
The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.
The hand grip strength
Time frame: 8 week after treatment
The hand grip strength of the patients will be measured with a North Coast hydraulic hand dynamometer. The average of 3 different repetitive measurements will be taken.
The finger pinch strength
Time frame: Before Treatment
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
The finger pinch strength
Time frame: 8 week after treatment
Finger pinch strength will be measured with a North Coast hydraulic pinch gauge. The average of 3 different repetitive measurements will be taken.
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: Before Treatment
This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.
Boston Carpal Tunnel Syndrome Questionnaire
Time frame: 8 week after treatment
This questionnaire consists of two parts: Boston Symptom Severity Scale (BSSS) and Boston Functional Capacity Scale (BFCS). BSSS consists of 11 questions, and BFCS consists of 8 questions. The score of each question varies between 1-5. High scores indicate severe symptoms and reduced functional capacity.
4 secondary outcomes
Disabilities of the Arm, Shoulder end Hand Questionnaire
Time frame: Before Treatment
Disabilities of the Arm, Shoulder end Hand Questionnaire
Time frame: 8 week after treatment
Short Form-36 Quality of Life Scale
Time frame: Before Treatment
Short Form-36 Quality of Life Scale
Time frame: 8 week after treatment
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 27 Feb 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 Phase 4 study testing Static wrist splint treatment, Tendon and nerve gliding exercises and Wrist local steroid injection in people with Carpal Tunnel Syndrome, run by Abant Izzet Baysal 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 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Before Treatment). The study lists 10 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 27 Feb 2025.