Adhesive CapsulitisNCT05678140
The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment
A study testing soft tissue mobilization and conventional physical therapy in people with Adhesive Capsulitis and ınstrument assısted Soft tıssue molılızatıon, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The primer aim of this study is to demonstrate the effect of instrument assisted soft tissue mobılızatıon on paın ,functıonality, joint range of motion patients with adhesive capsulitis Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Adhesive Capsulitis, ınstrument assısted Soft tıssue molılızatıon
- What is being tested?
- soft tissue mobilization and conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 20 Sep 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1.Male and Female patients aged 20-60 years 2.Diagnosed with adhesive capsulitis 2. Loss of range of motion in the capsular pattern (external rotation > abduction > internal rotation) will be included in the study.
- 3. consent to participate
Who cannot join
- 1. Injury to the upper extremity in the last 6 months 2. Shoulder injection in the last 6 months 3. Existing open wound in the upper extremity area 4. Previous upper extremity surgery 5. Being hypersensitive 6. Having a generalized infection 7. Having uncontrolled hypertension 8. Inability to cooperate; 9. The patient's unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Faculty of Medicine
Kırşehir, City Center, 40100
About this study
The primer aim of this study is to demonstrate the effect of instrument assisted soft tissue mobılızatıon on paın ,functıonality, joint range of motion patients with adhesive capsulitis
Read the detailed description
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.
It is characterized by shoulder pain, decreased range of motion, and limitation of function. This affects the function of the entire upper extremity. Idiopathic adhesive capsulitis usually involves the non-dominant upper extremity, with bilateral involvement in 40-50% of cases. It is more common in women between the ages of 40 and 60. The incidence of adhesive capsulitis among the population is between 3% and 5%. It has been reported with up to 20% higher incidence in the diabetic population. It is also associated with other pathological disorders such as thyroid dysfunction, coronary artery disease and cerebrovascular disease. Although the pathology is self-limiting, long-term symptoms develop in approximately 20% to 50% of cases.
Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.
- The painful phase lasts less than three months and presents with shoulder pain at night when glenohumeral movement is preserved.
- The freezing process lasts three to nine months and is manifested by severe pain and stiffness in the glenohumeral joint.
- The frozen shoulder process lasts nine to fourteen months and is eventually characterized by loss of motion and pain in all directions.
- The resolution phase lasts for fifteen to twenty-four months and is characterized by persistent stiffness, minimal pain, and delayed improvement in shoulder motion.
Abnormal shoulder kinematics develops in response to the lack of extensibility of the capsule with the change in motor patterns in the central nervous system. Increased thoracic kyphosis can be seen as postural deviations. However, fibrotic changes are also seen in the periarticular connective tissue and trigger points. This presents as a higher level of disability with painful shoulder. Physiotherapy is the mainstay of treatment for patients with adhesive capsulitis. Joint mobilization has a proven role in conjunction with Codman's exercises. Transcutaneous Electrical Nerve Stimulation (TENS), Diathermy is used in the treatment to reduce pain. Instrument Assisted Soft Tissue Mobilization (IASTM) is a soft tissue mobilization method that works by generating localized inflammation and facilitates collagen synthesis and realignment. In fact, when IASTM is given to soft tissues with appropriate pressure, localized inflammation occurs with microvascular bleeding. This will increase blood flow to the injured area along with the recruitment of more fibroblasts. With the removal of scar tissues and adhesions, healing will be supported by the organization of collagen of fibroblasts. The fibronectin induced by IASTM is required for tissue repair. A localized force will be transmitted through an instrument to the affected tissues to leave a scar.
IASTM has become increasingly popular as a tool for the rehabilitation of sports injuries. It has been proven to be successful in a short time in reducing pain and increasing mobility after sports injuries. There are studies showing an increase in ROM after a single application of this technique.
It is known that it takes a long time to relieve pain and achieve a good improvement in ROM in adhesive capsulitis. This affects their quality of life and creates the need for treatment options that provide a shorter recovery time. Various conservative protocols are followed with physical therapy as the main treatment in adhesive capsulitis. Few studies have used IASTM as a treatment to evaluate its effect on adhesive capsulitis.
- Being tested
- soft tissue mobilization, conventional physical therapy
- Keywords
- adhesıve capsulıtis, ınstrument assısted soft tıssue molılızatıon
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue mobilizationDevice
soft tissue mobilization; For the shoulder area, the application will take between 3-5 minutes. Instrumental Soft tissue mobilization will be performed while the participant is sitting in a supported chair, parallel to the shoulder and scapular muscle fibers and at an angle of 45 degrees to the vertical. Patients will be told that there may be small red spots called petechiae in the treated area. The application will be made using Graston iron rods.
conventional physical therapyOther
Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area
| Study group | Role | What they receive |
|---|---|---|
| soft tissue mobilization+conventional physical therapy | Experimental | Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area soft tissue mobilization; For the shoulder area, the application will take between 3-5 minutes. Instrumental Soft tissue mobilization will be performed while the participant is sitting in a supported chair, parallel to the shoulder and scapular muscle fibers and at an angle of 45 degrees to the vertical. Patients will be told that there may be small red spots called petechiae in the treated area. The application will be made using Graston iron rods. Receives: Device: soft tissue mobilization; Other: conventional physical therapy |
| conventional physical therapy | Placebo comparator | Hot-pack to warm the superficial tissue, TENS for pain relief, ultrasound to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.
Measured: baseline
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.
Measured: 2. week (in the middle of treatment)
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.
Measured: 4. week (at the end of treatment)
The Shoulder Pain and Disability Index (SPADI)
SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.
Measured: baseline
The Shoulder Pain and Disability Index (SPADI)
SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.
Measured: 2. week (in the middle of treatment)
The Shoulder Pain and Disability Index (SPADI)
SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.
Measured: 4. week (at the end of treatment)
Secondary outcomes (3)
joint range of motion
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
Measured: baseline
joint range of motion
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
Measured: 2. week (in the middle of treatment)
joint range of motion
measured using a protractor. Shoulder flexion, extension, abduction, internal rotation and external rotation intervals are measured in the supine position.
Measured: 4. week (at the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Apr 2022
- Primary completion20 Aug 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Model description
- randomızed controlled trıal
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem Karacay, Assoc. Prof, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678140
- Sponsor's protocol ID
- E-77504701-604.-02.
- Status last verified
- Aug 2024
- First submitted
- 23 Dec 2022
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal A, Saxena K, Palekar TJ, Rathi M. Instrument assisted soft tissue mobilization in adhesive capsulitis: A randomized clinical trial. J Bodyw Mov Ther. 2021 Apr;26:435-442. doi: 10.1016/j.jbmt.2020.12.039. Epub 2020 Dec 31.
PubMed 33992280Laudner K, Compton BD, McLoda TA, Walters CM. Acute effects of instrument assisted soft tissue mobilization for improving posterior shoulder range of motion in collegiate baseball players. Int J Sports Phys Ther. 2014 Feb;9(1):1-7.
PubMed 24567849Hussey MJ, Boron-Magulick AE, Valovich McLeod TC, Welch Bacon CE. The Comparison of Instrument-Assisted Soft Tissue Mobilization and Self-Stretch Measures to Increase Shoulder Range of Motion in Overhead Athletes: A Critically Appraised Topic. J Sport Rehabil. 2018 Jul 1;27(4):385-389. doi: 10.1123/jsr.2016-0213. Epub 2018 Jun 1.
PubMed 28253058
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Instrument Assisted Soft Tissue Mobilization in Adhesive Capsulıtıs Treatment
- ClinicalTrials.gov ID
- NCT05678140
- Acronym / sponsor ID
- E-77504701-604.-02.
- Keywords
- adhesıve capsulıtis, ınstrument assısted soft tıssue molılızatıon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 10 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 primer aim of this study is to demonstrate the effect of instrument assisted soft tissue mobılızatıon on paın ,functıonality, joint range of motion patients with adhesive capsulitis
Detailed description
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.
It is characterized by shoulder pain, decreased range of motion, and limitation of function. This affects the function of the entire upper extremity. Idiopathic adhesive capsulitis usually involves the non-dominant upper extremity, with bilateral involvement in 40-50% of cases. It is more common in women between the ages of 40 and 60. The incidence of adhesive capsulitis among the population is between 3% and 5%. It has been reported with up to 20% higher incidence in the diabetic population. It is also associated with other pathological disorders such as thyroid dysfunction, coronary artery disease and cerebrovascular disease. Although the pathology is self-limiting, long-term symptoms develop in approximately 20% to 50% of cases.
Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.
- The painful phase lasts less than three months and presents with shoulder pain at night when glenohumeral movement is preserved.
- The freezing process lasts three to nine months and is manifested by severe pain and stiffness in the glenohumeral joint.
- The frozen shoulder process lasts nine to fourteen months and is eventually characterized by loss of motion and pain in all directions.
- The resolution phase lasts for fifteen to twenty-four months and is characterized by persistent stiffness, minimal pain, and delayed improvement in shoulder motion.
Abnormal shoulder kinematics develops in response to the lack of extensibility of the capsule with the change in motor patterns in the central nervous system. Increased thoracic kyphosis can be seen as postural deviations. However, fibrotic changes are also seen in the periarticular connective tissue and trigger points. This presents as a higher level of disability with painful shoulder. Physiotherapy is the mainstay of treatment for patients with adhesive capsulitis. Joint mobilization has a proven role in conjunction with Codman's exercises. Transcutaneous Electrical Nerve Stimulation (TENS), Diathermy is used in the treatment to reduce pain. Instrument Assisted Soft Tissue Mobilization (IASTM) is a soft tissue mobilization method that works by generating localized inflammation and facilitates collagen synthesis and realignment. In fact, when IASTM is given to soft tissues with appropriate pressure, localized inflammation occurs with microvascular bleeding. This will increase blood flow to the injured area along with the recruitment of more fibroblasts. With the removal of scar tissues and adhesions, healing will be supported by the organization of collagen of fibroblasts. The fibronectin induced by IASTM is required for tissue repair. A localized force will be transmitted through an instrument to the affected tissues to leave a scar.
IASTM has become increasingly popular as a tool for the rehabilitation of sports injuries. It has been proven to be successful in a short time in reducing pain and increasing mobility after sports injuries. There are studies showing an increase in ROM after a single application of this technique.
It is known that it takes a long time to relieve pain and achieve a good improvement in ROM in adhesive capsulitis. This affects their quality of life and creates the need for treatment options that provide a shorter recovery time. Various conservative protocols are followed with physical therapy as the main treatment in adhesive capsulitis. Few studies have used IASTM as a treatment to evaluate its effect on adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- randomızed controlled trıal
| Arm | Type | Receives |
|---|---|---|
| soft tissue mobilization+conventional physical therapy | Experimental | Device: soft tissue mobilization, Other: conventional physical therapyHot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area soft tissue mobilization; For the shoulder area, the application will take between 3-5 minutes. Instrumental Soft tissue mobilization will be performed while the participant is sitting in a supported chair, parallel to the shoulder and scapular muscle fibers and at an angle of 45 degrees to the vertical. Patients will be told that there may be small red spots called petechiae in the treated area. The application will be made using Graston iron rods. |
| conventional physical therapy | Placebo comparator | Other: conventional physical therapyHot-pack to warm the superficial tissue, TENS for pain relief, ultrasound to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1.Male and Female patients aged 20-60 years 2.Diagnosed with adhesive capsulitis 2. Loss of range of motion in the capsular pattern (external rotation > abduction > internal rotation) will be included in the study.
- 3. consent to participate
Key exclusion criteria (1 listed)
- 1. Injury to the upper extremity in the last 6 months 2. Shoulder injection in the last 6 months 3. Existing open wound in the upper extremity area 4. Previous upper extremity surgery 5. Being hypersensitive 6. Having a generalized infection 7. Having uncontrolled hypertension 8. Inability to cooperate; 9. The patient's unwillingness to participate in the study
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 |
|---|---|---|
| soft tissue mobilizationsoft tissue mobilization; For the shoulder area, the application will take between 3-5 minutes. Instrumental Soft tissue mobilization will be performed while the participant is sitting in a supported chair, parallel to the shoulder and scapular muscle fibers and at an angle of 45 degrees to the vertical. Patients will be told that there may be small red spots called petechiae in the treated area. The application will be made using Graston iron rods. | Device | soft tissue mobilization+conventional physical therapy |
| conventional physical therapyHot-pack to warm the superficial tissue, TENS for pain relief, ultrasound (US) to warm the joint structures before mobilization techniques, ROM, stretching, and isometric strengthening exercises to restore joint mobility and function of the shoulder area | Other | conventional physical therapy, soft tissue mobilization+conventional physical therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: baseline
Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.
Visual Analogue Scale (VAS)
Time frame: 2. week (in the middle of treatment)
Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.
Visual Analogue Scale (VAS)
Time frame: 4. week (at the end of treatment)
Visual Analogue Scale (VAS) for pain assesment .In tgis scale ,evaluaments paın with 10- point Likert scale , 0 is scored as no pain,5 as modarete pain , and 10 as excrucıatıng pain.
The Shoulder Pain and Disability Index (SPADI)
Time frame: baseline
SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.
The Shoulder Pain and Disability Index (SPADI)
Time frame: 2. week (in the middle of treatment)
SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.
The Shoulder Pain and Disability Index (SPADI)
Time frame: 4. week (at the end of treatment)
SPADI is a pain and functional disability questionnaire specifically for the shoulder. It is divided into two parts: the pain scale (5 questions) and the disability scale (8 questions). Each question is rated on a scale from 0 to 10. The final score is calculated as a percentage.
3 secondary outcomes
joint range of motion
Time frame: baseline
joint range of motion
Time frame: 2. week (in the middle of treatment)
joint range of motion
Time frame: 4. week (at the end of treatment)
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 5 Aug 2024.
- Results publication: PubMed 33992280Aggarwal A, Saxena K, Palekar TJ, Rathi M. Instrument assisted soft tissue mobilization in adhesive capsulitis: A randomized clinical trial. J Bodyw Mov Ther. 2021 Apr;26:435-442. doi: 10.1016/j.jbmt.2020.12.039. Epub 2020 Dec 31.
- Results publication: PubMed 24567849Laudner K, Compton BD, McLoda TA, Walters CM. Acute effects of instrument assisted soft tissue mobilization for improving posterior shoulder range of motion in collegiate baseball players. Int J Sports Phys Ther. 2014 Feb;9(1):1-7.
- Results publication: PubMed 28253058Hussey MJ, Boron-Magulick AE, Valovich McLeod TC, Welch Bacon CE. The Comparison of Instrument-Assisted Soft Tissue Mobilization and Self-Stretch Measures to Increase Shoulder Range of Motion in Overhead Athletes: A Critically Appraised Topic. J Sport Rehabil. 2018 Jul 1;27(4):385-389. doi: 10.1123/jsr.2016-0213. Epub 2018 Jun 1.
- 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.
Basak Cigdem Karacay, Assoc. Prof 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 soft tissue mobilization and conventional physical therapy in people with Adhesive Capsulitis and ınstrument assısted Soft tıssue molılızatıon, run by Kirsehir Ahi Evran Universitesi 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 2 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 5 Aug 2024. 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?
Visual Analogue Scale (VAS) (time frame: baseline). 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?
On the ClinicalTrials.gov record for NCT05678140, which also lists 3 linked publications.
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 5 Aug 2024.