Adhesive CapsulitisNCT05689593
Comparison of Low-intensity Extracorporeal Shockwave Therapy and Low-intensity Laser Effects in Adhesive Capsulitis
A study testing Low-intensity ESWT Group and Low-intensity laser Group in people with Adhesive Capsulitis, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Low-intensity ESWT Group and Low-intensity laser Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2023to 2 Aug 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients who have received "adhesive capsulitis" by clinical and examination
- Patients with loss of range of motion in the capsular pattern (external rotation > abduction > internal rotation) will be included in the study.
- Patients who consent to participate in the study according to the informed consent form will be included in the study.
Who cannot join
- Upper extremity injury in the last 6 months
- Shoulder injection in the last 6 months
- Existing open wound in the upper extremity area
- Prior upper extremity surgery
- The patient has a systemic infection
- Uncontrolled hypertension in the patient
Show all 9Show fewer
- Inability of the patient to cooperate
- The patient's unwillingness to participate in the study
- The patient has a malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran Üniversitesi
Kırşehir, Central Anatolia
About this study
Official title: Comparison of the Efficiency of Low Intensity Extracorporeal Shock Wave Therapy and Low Intensity Laser Therapy in Adhesive Capsulitis Treatment: a Randomized Controlled Study
The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate whether they are superior to the control group.
Read the detailed description
In this study, 60 adhesive capsulitis with age range 18-65 who applied to Kırsehir Ahi Evran University Training and Research Hospital were examined.Adhesive capsulitis is also called arthrofibrosis, which involves excessive adhesion formation along the glenohumeral joint. It is a disease of unknown etiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis, central nervous system involvement, arm immobilized for a long time, trauma or fracture, infectious diseases, etc. Includes post-mortem situations.
Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.
low-level laser therapy supports cell proliferation and tissue regeneration with its anti-inflammatory and photobiostimulation properties.The pressure waves of ESWT pass through fluids and soft tissues and exert their effects in areas of impedance change such as bones and soft tissue spaces. These waves have mechanical and cellular effects. The most important of these effects are temporary damage to the neuronal cell membrane or increased permeability. These mechanisms may facilitate neovascularization and cellular regeneration in tissues.
- Conditions
- Adhesive Capsulitis
- Being tested
- Low-intensity ESWT Group, Low-intensity laser Group, Conventional Control Group
- Keywords
- Rehabilitation, extracorporeal shock wave therapy, low-level laser therapy, pain
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity ESWT GroupOther
ESWT; With the MODUS ESWT system, the patient's shoulder will be in 80° passive abduction, the elbow will be in 90° flexion, and the forearm will be applied to 2 separate parts of the shoulder. The first application will be applied from front to back in the anterior shoulder joint and the upper limit of the treatment will be approximately 1 finger lateral to the coracoid process, the second application will be applied from the lateral scapula to the posterior shoulder joint (0.06 mJ/mm2, 1500 impulses, 1.5 bar).( Modus ESWT® RadialShockwaveTherapy)
Low-intensity laser GroupOther
The laser will be made parallel to the joint line with the patient's arm, the arm will be in internal rotation at the posterior of the shoulder and the arm will be in external rotation at the anterior of the shoulder. The wavelength of 850 nm will be applied for 5 minutes in total 30 Joules.
Conventional Control GroupOther
Exercises will be started with passive ROM exercises and passive stretching exercises for the flexor, abductor, internal and external rotator muscle groups until the level of pain tolerance in the supine position. In the second week, the program will be continued with active ROM and stretching exercises. In the third week, isometric strengthening exercises for flexor, abductor, internal and external rotator muscle groups will be given along with stretching exercises. Exercises will be performed 5 days a week, 60 minutes a day, accompanied by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity ESWT Group | Active comparator | low intensity extracorporeal shock wave therapy will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises Receives: Other: Low-intensity ESWT Group; Other: Conventional Control Group |
| Low-intensity laser Group | Active comparator | low intensity laser will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises Receives: Other: Low-intensity laser Group; Other: Conventional Control Group |
| Conventional Control Group | Other | patients will receive a conventional therapy program consisting of hotpack and exercises Receives: Other: Conventional Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Measured: 0. week
Visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Measured: 3. week
Visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Measured: 12. week
CONSTANT (MURLEY) SCORE (CS)
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
Measured: 0. week
CONSTANT (MURLEY) SCORE (CS)
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
Measured: 3. week
CONSTANT (MURLEY) SCORE (CS)
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
Measured: 12.week
Secondary outcomes (6)
Pittsburgh Sleep Quality Index
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Measured: 0. week
Pittsburgh Sleep Quality Index
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Measured: 3. week
Pittsburgh Sleep Quality Index
This scale was developed by Busse et al. Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality and disorder and consists of seven subcomponents (subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, drug use, and daytime functions) and 19 items. Each component is evaluated on a score of 0-3 and is evaluated with a total sleep score ranging from 0 to 21, and high scores represent low sleep quality. A PSQI total score < 5 points is considered "good" sleep quality and > 5 points is "bad" sleep quality.
Measured: 12. week
The Short Form Health Survey (SF-36)
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
Measured: 0. week
The Short Form Health Survey (SF-36)
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
Measured: 3. week
The Short Form Health Survey (SF-36)
This scale was developed to assess the quality of life associated with general health status and its Turkish validity and reliability was made by Koçyiğit et al. The Short Form Health Survey (SF-36) measures the health domains of physical functioning, physical role, body pain, general health, vitality, social function, emotional role, and mental health. The subscales evaluate health between 0 and 100 scores. The higher the score indicates better health status. In this study, physical health score was calculated by means of physical function, physical role limitation, pain, and general health subscales. Mental health score was calculated by averaging the energy/vitality, social function, emotional role limitation, and mental health subscales
Measured: 12. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start21 Jan 2023
- Primary completion2 May 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with a conventional therapy control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İSMAİL CEYLAN, Ahi Evran University Education and Research Hospital
- Investigators
- ismail Ceylan, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689593
- Sponsor's protocol ID
- AEU-FTR-FE-01
- Status last verified
- Aug 2023
- First submitted
- 13 Dec 2022
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Low Intensity Extracorporeal Shock Wave Therapy and Low Intensity Laser Therapy in Adhesive Capsulitis Treatment: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05689593
- Acronym / sponsor ID
- AEU-FTR-FE-01
- Conditions
- Adhesive Capsulitis
- Keywords
- Rehabilitation, extracorporeal shock wave therapy, low-level laser therapy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate whether they are superior to the control group.
Detailed description
In this study, 60 adhesive capsulitis with age range 18-65 who applied to Kırsehir Ahi Evran University Training and Research Hospital were examined.Adhesive capsulitis is also called arthrofibrosis, which involves excessive adhesion formation along the glenohumeral joint. It is a disease of unknown etiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis, central nervous system involvement, arm immobilized for a long time, trauma or fracture, infectious diseases, etc. Includes post-mortem situations.
Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.
low-level laser therapy supports cell proliferation and tissue regeneration with its anti-inflammatory and photobiostimulation properties.The pressure waves of ESWT pass through fluids and soft tissues and exert their effects in areas of impedance change such as bones and soft tissue spaces. These waves have mechanical and cellular effects. The most important of these effects are temporary damage to the neuronal cell membrane or increased permeability. These mechanisms may facilitate neovascularization and cellular regeneration in tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Three groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Low-intensity ESWT Group | Active comparator | Other: Low-intensity ESWT Group, Other: Conventional Control Grouplow intensity extracorporeal shock wave therapy will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises |
| Low-intensity laser Group | Active comparator | Other: Low-intensity laser Group, Other: Conventional Control Grouplow intensity laser will be applied to patients shoulder, also patients will receive a conventional therapy program consisting of hotpack and exercises |
| Conventional Control Group | Other | Other: Conventional Control Grouppatients will receive a conventional therapy program consisting of hotpack and exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male and female patients who have received "adhesive capsulitis" by clinical and examination
- Patients with loss of range of motion in the capsular pattern (external rotation > abduction > internal rotation) will be included in the study.
- Patients who consent to participate in the study according to the informed consent form will be included in the study.
Key exclusion criteria (9 listed)
- Upper extremity injury in the last 6 months
- Shoulder injection in the last 6 months
- Existing open wound in the upper extremity area
- Prior upper extremity surgery
- The patient has a systemic infection
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 |
|---|---|---|
| Low-intensity ESWT GroupESWT; With the MODUS ESWT system, the patient's shoulder will be in 80° passive abduction, the elbow will be in 90° flexion, and the forearm will be applied to 2 separate parts of the shoulder. The first application will be applied from front to back in the anterior shoulder joint and the upper limit of the treatment will be approximately 1 finger lateral to the coracoid process, the second application will be applied from the lateral scapula to the posterior shoulder joint (0.06 mJ/mm2, 1500 impulses, 1.5 bar).( Modus ESWT® RadialShockwaveTherapy) | Other | Low-intensity ESWT Group |
| Low-intensity laser GroupThe laser will be made parallel to the joint line with the patient's arm, the arm will be in internal rotation at the posterior of the shoulder and the arm will be in external rotation at the anterior of the shoulder. The wavelength of 850 nm will be applied for 5 minutes in total 30 Joules. | Other | Low-intensity laser Group |
| Conventional Control GroupExercises will be started with passive ROM exercises and passive stretching exercises for the flexor, abductor, internal and external rotator muscle groups until the level of pain tolerance in the supine position. In the second week, the program will be continued with active ROM and stretching exercises. In the third week, isometric strengthening exercises for flexor, abductor, internal and external rotator muscle groups will be given along with stretching exercises. Exercises will be performed 5 days a week, 60 minutes a day, accompanied by a physiotherapist. | Other | Conventional Control Group, Low-intensity ESWT Group, Low-intensity laser Group |
Primary outcome
Visual analogue scale (VAS)
Time frame: 0. week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Visual analogue scale (VAS)
Time frame: 3. week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
Visual analogue scale (VAS)
Time frame: 12. week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
CONSTANT (MURLEY) SCORE (CS)
Time frame: 0. week
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
CONSTANT (MURLEY) SCORE (CS)
Time frame: 3. week
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
CONSTANT (MURLEY) SCORE (CS)
Time frame: 12.week
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
6 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: 0. week
Pittsburgh Sleep Quality Index
Time frame: 3. week
Pittsburgh Sleep Quality Index
Time frame: 12. week
The Short Form Health Survey (SF-36)
Time frame: 0. week
The Short Form Health Survey (SF-36)
Time frame: 3. week
The Short Form Health Survey (SF-36)
Time frame: 12. week
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 3 Aug 2023.
- 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.
ismail Ceylan, PhD principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity ESWT Group and Low-intensity laser Group in people with Adhesive Capsulitis, run by Ahi Evran University Education and Research Hospital 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 9 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 3 Aug 2023. 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.
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?
Visual analogue scale (VAS) (time frame: 0. week). The study lists 6 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 3 Aug 2023.