Frozen ShoulderNCT03711409
Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy in Patients With Frozen Shoulder
A study testing Soft tissue biased manual therapy group and Conventional physical therapy group in people with Frozen Shoulder and Shoulder Adhesive Capsulitis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by the functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Shoulder pain almost exists during the whole course of frozen shoulder. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Frozen Shoulder, Shoulder Adhesive Capsulitis
- What is being tested?
- Soft tissue biased manual therapy group and Conventional physical therapy group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Dec 2018to 28 Feb 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary adhesive capsulitis diagnosed by orthopaedic surgeon or physiatrist
- Reduction in range of motion in more than two planes
- < 30 degrees of the external rotation range of motion during shoulder abduct to 90 degree
- No radiologic abnormality
- Onset time more than three months
- No night pain and resting pain
Who cannot join
- History of stroke, diabetes mellitus, rheumatoid arthritis, rotator cuff tear, shoulder osteoarthritis, surgical stabilization/surgery of the shoulder, osteoporosis, or malignancies in the shoulder region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy on Shoulder Kinematics, Muscle Performance, Functional Impairment & Pain in Patients With Frozen Shoulder
Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by the functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Shoulder pain almost exists during the whole course of frozen shoulder. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control. Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatments. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy in patients with primary FS.
Read the detailed description
Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by a functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Frozen shoulder is divided into primary and secondary type. The mechanism of primary FS is still unknown and the secondary FS may accompany with shoulder injuries. The incidence of primary FS is 2 to 5.8% and the risk factors are diabetes and thyroid disease.
The course of FS is divided into four consecutive stages which are inflammation, painful, frozen and thawing phase. Shoulder pain almost exists during the whole course of frozen shoulder. The pain and discomfort of FS patients are frequently localized to the deltoid insertion and coracoid process. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control.
Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatment s. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Only one study used one-time muscle release to FS patients and investigate improvement in shoulder biomechanics, muscle strength and ROM. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy for six weeks in patients with primary FS.
The study design is a pretest-posttest control group design. The investigators plan to recruit 70 patients with primary frozen shoulder and divide them into a soft tissue biased manual therapy group and a conventional physical therapy group. The sample size is determined by the previous study. It is based on a significance level of 0.05, and a power of 0.80. The outcome measures in this study include scapula kinematics, scapula position, the range of motion, muscle tone, muscle strength, pain and functional impairment.
LIBERTY™ electromagnetic tracking system (Polhemus, Colchester, VT, USA) was used to collect three-dimensional kinematic (3D) data during scaption, hand to neck and hand to back tasks at a sampling rate of 120 Hz, and the software Motion Monitor® (Innovative Sport Training, Inc., Chicago. IL. USA) was used to analyze the data. The main measurements of shoulder kinematics include scapular upward/downward rotation, internal/external rotation, and anterior/posterior tilt. A stylus was used to digitize the bony landmarks for defining the anatomical coordinate system. The methods for this measure have been described previously.
For collecting muscle activation data, the investigators used surface electromyography (sEMG, TeleMyo 2400 G2 Telemetry; Noraxon USA, Inc., USA) to collect scapular muscles' activation during those tasks. The investigators will measure the muscle activities of the pectoralis major, upper trapezius, infraspinatus, teres major and lower trapezius. The electrodes will be placed according to previous studies and be positioned in parallel to the direction of the muscle fibers.
The range of motion of shoulder flexion, abduction, external rotation and internal rotation will be measured by plastic universal goniometer according to Norkin's methods. The muscle strength of lower trapezius, external rotators and internal rotators are measured by the hand-held dynamometer. The scapula positions are measured by modified scapular sliding test with calliper during arms by sides, hands on the hips and scaption 90 degrees. The muscle tone of pectoralis major, upper trapezius, infraspinatus and teres complex will be measured by hand-held myotonometer (Myoton-Pro, Myoton AS, Tallinn, Estonia) in shoulder resting position according to previous studies. The functional impairments are measured by Flexilevel Scale of Shoulder Function questionnaire. The pain level is measured by the visual analogue scale.
Participants in the soft tissue biased manual therapy group will receive heat and muscle release for six weeks and participants in conventional physical therapy group will receive modalities and joint mobilization for six weeks. The measurement will be obtained at baseline, 3 weeks, and after the intervention. Repeated measures ANOVA will be used for data analysis. The level of significance sets at α=0.05.
- Conditions
- Frozen Shoulder, Shoulder Adhesive Capsulitis
- Being tested
- Soft tissue biased manual therapy group, Conventional physical therapy group
- Keywords
- Frozen Shoulder, Manual therapy, Soft tissue mobilization
- 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 biased manual therapy groupOther
It includes hot pack and muscle release technique of pectoralis major, pectoralis minor, teres major, teres minor, infraspinatus and posterior deltoid muscles. Subjects are supine on the bed. The muscle release technique is applied at the end available range and the acceptable intensity. The time of muscle release intervention is about 30 min and hot-pack about 15 min.
Conventional physical therapy groupOther
It includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. GH joint mobilization includes anterior to posterior glide, caudal glide and distraction. The intensity of joint mobilization is grade III to IV. The time of joint mobilization is about 30 min and hot-pack for 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Soft tissue biased manual therapy group | Experimental | It includes hot pack and muscle release technique of the muscles around the shoulder. The patient receives treatment 45 minutes per times and 2 times per week for 6 weeks. Receives: Other: Soft tissue biased manual therapy group |
| Conventional physical therapy group | Experimental | It includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. The patient receives treatment 45 minutes per times and 2 times per week for 6 weeks. Receives: Other: Conventional physical therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapulo-humeral rhythm (scapular kinematics) during functional movements
Change from baseline of scapular kinematics to after 6 week intervention during scaption task, hand to neck task and hand to back task
Measured: Baseline and after 6-week intervention
Secondary outcomes (10)
Range of motion of shoulder joint (Goniometer)
Shoulder range of motion in degree of flexion, abduction, internal rotation and external rotation
Measured: Baseline, 3-week intervention and 6-week intervention
Mechanical stress relaxation time (ms) of shoulder muscles
We use Myotometer to measure mechanical stress relaxation time (ms) of pectoralis major, infraspinatus, teres complex and upper trapezius
Measured: Baseline, 3-week intervention and 6-week intervention
Creep of shoulder muscles
We use Myotometer to measure creep of pectoralis major, infraspinatus, teres complex and upper trapezius
Measured: Baseline, 3-week intervention and 6-week intervention
Oscillation frequency (Hz) of shoulder muscles
We use Myotometer to measure oscillation frequency (Hz) of pectoralis major, infraspinatus, teres complex and upper trapezius
Measured: Baseline, 3-week intervention and 6-week intervention
Dynamic stiffness (N/m) of shoulder muscles
We use Myotometer to measure dynamic stiffness (N/m) of pectoralis major, infraspinatus, teres complex and upper trapezius
Measured: Baseline, 3-week intervention and 6-week intervention
Muscle strength of shoulder muscles (Hand-held Dyanometer)
Shoulder muscle strength in Kgw of lower trapezius, internal rotators and external rotators
Measured: Baseline, 3-week intervention and 6-week intervention
Scapula dyskinesia
Use modified lateral scapular slide test to measure during arms by sides, hands on hips and scaption movement
Measured: Baseline, 3-week intervention and 6-week intervention
Shoulder disability
Use Flexilevel Scale of Shoulder Function (Flex-SF) questionnaire Chinese version to measure the disability level of frozen shoulder patients. Flex-SF uses 4-point Likert Scale to measure the disability level. Subjects need to answer a routing question and subgroup them into three different difficulty level. The scores range from 1 to 48 (1= most disable, 48= least disable).
Measured: Baseline, 3-week intervention and 6-week intervention
Shoulder pain
Use visual analogue scale to measure shoulder pain of frozen shoulder patients. We will provide subjects a 10-cm scale for them to point the intensity of their pain (on a 10-cm scale, 0 cm = no pain, 10 cm = the most severe pain).
Measured: Baseline, 3-week intervention and 6-week intervention
Scapula motor control (muscle activation percentage)
Change from baseline of scapular muscles' activation in percentage during scaption, hand to neck and hand to back task to after 6-week intervention
Measured: Baseline and after 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 posted18 Oct 2018
- Study start25 Dec 2018
- Primary completion31 Jan 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects are divided into soft tissue biased manual therapy group and conventional physical therapy group by two different hospitals
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Shih Yi-Fen, PhD, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711409
- Sponsor's protocol ID
- TCHIRB-10705119-E
- Status last verified
- Aug 2021
- First submitted
- 6 Aug 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy on Shoulder Kinematics, Muscle Performance, Functional Impairment & Pain in Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT03711409
- Acronym / sponsor ID
- TCHIRB-10705119-E
- Conditions
- Frozen Shoulder, Shoulder Adhesive Capsulitis
- Keywords
- Frozen Shoulder, Manual therapy, Soft tissue mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Oct 2018 (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.
Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by the functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Shoulder pain almost exists during the whole course of frozen shoulder. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control. Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatments. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy in patients with primary FS.
Detailed description
Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by a functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Frozen shoulder is divided into primary and secondary type. The mechanism of primary FS is still unknown and the secondary FS may accompany with shoulder injuries. The incidence of primary FS is 2 to 5.8% and the risk factors are diabetes and thyroid disease.
The course of FS is divided into four consecutive stages which are inflammation, painful, frozen and thawing phase. Shoulder pain almost exists during the whole course of frozen shoulder. The pain and discomfort of FS patients are frequently localized to the deltoid insertion and coracoid process. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control.
Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatment s. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Only one study used one-time muscle release to FS patients and investigate improvement in shoulder biomechanics, muscle strength and ROM. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy for six weeks in patients with primary FS.
The study design is a pretest-posttest control group design. The investigators plan to recruit 70 patients with primary frozen shoulder and divide them into a soft tissue biased manual therapy group and a conventional physical therapy group. The sample size is determined by the previous study. It is based on a significance level of 0.05, and a power of 0.80. The outcome measures in this study include scapula kinematics, scapula position, the range of motion, muscle tone, muscle strength, pain and functional impairment.
LIBERTY™ electromagnetic tracking system (Polhemus, Colchester, VT, USA) was used to collect three-dimensional kinematic (3D) data during scaption, hand to neck and hand to back tasks at a sampling rate of 120 Hz, and the software Motion Monitor® (Innovative Sport Training, Inc., Chicago. IL. USA) was used to analyze the data. The main measurements of shoulder kinematics include scapular upward/downward rotation, internal/external rotation, and anterior/posterior tilt. A stylus was used to digitize the bony landmarks for defining the anatomical coordinate system. The methods for this measure have been described previously.
For collecting muscle activation data, the investigators used surface electromyography (sEMG, TeleMyo 2400 G2 Telemetry; Noraxon USA, Inc., USA) to collect scapular muscles' activation during those tasks. The investigators will measure the muscle activities of the pectoralis major, upper trapezius, infraspinatus, teres major and lower trapezius. The electrodes will be placed according to previous studies and be positioned in parallel to the direction of the muscle fibers.
The range of motion of shoulder flexion, abduction, external rotation and internal rotation will be measured by plastic universal goniometer according to Norkin's methods. The muscle strength of lower trapezius, external rotators and internal rotators are measured by the hand-held dynamometer. The scapula positions are measured by modified scapular sliding test with calliper during arms by sides, hands on the hips and scaption 90 degrees. The muscle tone of pectoralis major, upper trapezius, infraspinatus and teres complex will be measured by hand-held myotonometer (Myoton-Pro, Myoton AS, Tallinn, Estonia) in shoulder resting position according to previous studies. The functional impairments are measured by Flexilevel Scale of Shoulder Function questionnaire. The pain level is measured by the visual analogue scale.
Participants in the soft tissue biased manual therapy group will receive heat and muscle release for six weeks and participants in conventional physical therapy group will receive modalities and joint mobilization for six weeks. The measurement will be obtained at baseline, 3 weeks, and after the intervention. Repeated measures ANOVA will be used for data analysis. The level of significance sets at α=0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects are divided into soft tissue biased manual therapy group and conventional physical therapy group by two different hospitals
| Arm | Type | Receives |
|---|---|---|
| Soft tissue biased manual therapy group | Experimental | Other: Soft tissue biased manual therapy groupIt includes hot pack and muscle release technique of the muscles around the shoulder. The patient receives treatment 45 minutes per times and 2 times per week for 6 weeks. |
| Conventional physical therapy group | Experimental | Other: Conventional physical therapy groupIt includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. The patient receives treatment 45 minutes per times and 2 times per week for 6 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary adhesive capsulitis diagnosed by orthopaedic surgeon or physiatrist
- Reduction in range of motion in more than two planes
- < 30 degrees of the external rotation range of motion during shoulder abduct to 90 degree
- No radiologic abnormality
- Onset time more than three months
Key exclusion criteria (1 listed)
- History of stroke, diabetes mellitus, rheumatoid arthritis, rotator cuff tear, shoulder osteoarthritis, surgical stabilization/surgery of the shoulder, osteoporosis, or malignancies in the shoulder region
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 biased manual therapy groupIt includes hot pack and muscle release technique of pectoralis major, pectoralis minor, teres major, teres minor, infraspinatus and posterior deltoid muscles. Subjects are supine on the bed. The muscle release technique is applied at the end available range and the acceptable intensity. The time of muscle release intervention is about 30 min and hot-pack about 15 min. | Other | Soft tissue biased manual therapy group |
| Conventional physical therapy groupIt includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. GH joint mobilization includes anterior to posterior glide, caudal glide and distraction. The intensity of joint mobilization is grade III to IV. The time of joint mobilization is about 30 min and hot-pack for 15 min. | Other | Conventional physical therapy group |
Primary outcome
Scapulo-humeral rhythm (scapular kinematics) during functional movements
Time frame: Baseline and after 6-week intervention
Change from baseline of scapular kinematics to after 6 week intervention during scaption task, hand to neck task and hand to back task
10 secondary outcomes
Range of motion of shoulder joint (Goniometer)
Time frame: Baseline, 3-week intervention and 6-week intervention
Mechanical stress relaxation time (ms) of shoulder muscles
Time frame: Baseline, 3-week intervention and 6-week intervention
Creep of shoulder muscles
Time frame: Baseline, 3-week intervention and 6-week intervention
Oscillation frequency (Hz) of shoulder muscles
Time frame: Baseline, 3-week intervention and 6-week intervention
Dynamic stiffness (N/m) of shoulder muscles
Time frame: Baseline, 3-week intervention and 6-week intervention
Muscle strength of shoulder muscles (Hand-held Dyanometer)
Time frame: Baseline, 3-week intervention and 6-week intervention
Scapula dyskinesia
Time frame: Baseline, 3-week intervention and 6-week intervention
Shoulder disability
Time frame: Baseline, 3-week intervention and 6-week intervention
Shoulder pain
Time frame: Baseline, 3-week intervention and 6-week intervention
Scapula motor control (muscle activation percentage)
Time frame: Baseline and after 6-week intervention
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 1 Sep 2021.
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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.
Shih Yi-Fen, PhD study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
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 biased manual therapy group and Conventional physical therapy group in people with Frozen Shoulder and Shoulder Adhesive Capsulitis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 6 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 1 Sep 2021. 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 Taiwan. 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?
Scapulo-humeral rhythm (scapular kinematics) during functional movements (time frame: Baseline and after 6-week intervention). 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 1 Sep 2021.