OsteoarthritisRCT-OANCT02247882
Effectiveness of Aquatic Physical Therapy for Knee Osteoarthritis Patients
A study testing Patient Education and Aquatic Physical Therapy in people with Osteoarthritis, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether education or aquatic physical therapy are effective in the treatment of osteoarthritis in Knee due to intensity of pain, function capacity, quality of life and kinetic. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Patient Education and Aquatic Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jun 2016
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged between 60 and 85 years;
- patients with knee OA by a physician confirmed by the criteria of American College of Rheumatology;
- patients with clinical and cognitive activities for the realization of the pool conditions, confirmed by the Mini-Exam Mental state.
Who cannot join
- patients undergoing surgical procedures in the last six months;
- patients with chronic diseases such as coronary, other rheumatic diseases such as rheumatoid arthritis; serious diseases such as cancer; chronic obstructive pulmonary diseases; uncontrolled hypertensive;
- patients unable to walk without aid equipment;
- patients who have contraindications to practice exercises;
- patients who have contraindications for entry into the pool, such as urinary or fecal incontinence and skin problems;
- patients participating in nutrition programs or physical activity in the last two months (or resisted aerobic activity more than once a week for at least two months);
Show all 9Show fewer
- patients with metal implants in the lower limbs;
- patients with morbid obesity (body mass index (BMI)> 40 kg / m 2);
- Patients unable to continue the study by programmed change of address or hospitalization.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Aquatic Physical Therapy Center "Paulo A. Seibert"
Londrina, Paraná, 86038440
About this study
Official title: Effectiveness of Health Education Compared to Aquatic Physical Therapy for Patients With Knee Osteoarthritis: a Randomized Clinical Trial
The purpose of this study is to determine whether education or aquatic physical therapy are effective in the treatment of osteoarthritis in Knee due to intensity of pain, function capacity, quality of life and kinetic.
Read the detailed description
Sixty patients will be recruited from clinics and through printed newspaper. Physicians who routinely evaluate patients with this diagnosis will be informed of the study, and the same will be announced by television call.
After passing a medical examination confirming the clinical diagnosis of knee osteoarthritis by American College of Rheumatology and other criteria, the elect will be informed of the objectives of the study and invited to participate.
After evaluation of the records of referrals of knee OA, patients receive phone calls, will be informed of the research objectives, questioned regarding the inclusion and exclusion criteria of the study and invited to participate in the study.
Upon study entry, personal information (name, age, gender, address and telephone) will be confirmed by a secretary, who will give the registration number of the patient. Personal information, as well as their radiographs, will be kept in personal form, with number of study enrollment.
Before and after implementation of treatment protocols, as well as after three months, all patients will be assessed by an independent examiner, ie, that have no knowledge about the intervention with respect to different variables. The independent examiner will have been previously trained for this role to become fit to do so.
Individuals will be assessed using the rubric for the outcomes of pain intensity using a Visual Analogue Scale (VAS); functional capacity of the Western Ontario and McMaster Universities Index (WOMAC); balance the Activities-specific Balance Confidence (ABC) and by static posturography and reaction forces to the ground by static force platform. Body weight will be checked by portable scale; height, and waist circumference with tape measure to calculate BMI.
After evaluation, patients will be divided by the numbers generated by the computer through the site (www.random.org) in both treatment groups with 30 patients. After the generation of numbers, they will be transformed into a card with the assigned treatment (1- Patient Education; 2 Aquatic Physiotherapy) and then placed in sealed, opaque, sequentially numbered envelopes. Thus, it prevented the evaluator and the therapist choose the group to which the patient is assigned. Procedures for randomization and allocation, as well as assessments and interventions will be blinded.
The educational program will comprise a multidisciplinary team: doctor, pharmacist, nurse, nutritionist, psychologist, physiotherapist and physical educator. Classes will be weekly in groups for eight weeks, lasting two hours, to be held in the Parlor of Our Lady of Grace Church, belonging to the scope of the Health Unit Vila Brazil.
The program will include education, following the suggestions of Coleman et al. the following items: guidelines about the disease and its complications, strategies for pain management (pharmacological and cognitive), physical exercise, nutrition and weight control, medication (type, interactions, current trends, side effects), balance, proprioception , fall prevention, coping with chronic pain. Following, practical activities on the themes will be addressed.
To enhance the information at the end, patients will receive printed material with the guidelines given by the professional. Still, the first and last day of the education program, patients will respond a questionnaire addressing their knowledge about the disease developed by the researchers.
Supervised aquatic exercise will run individually, twice a week, lasting 60 minutes, for eight weeks, totaling 16 sessions at the Center for Aquatic Physical Therapy Professor Paulo Armindo Seibert, Universidade Estadual de Londrina. The water temperature will be maintained at approximately 32 degrees, with a depth of 1.20m. The exercise protocol will consist of: five minutes of heating with walking and patellar mobilization; ten minutes stretching the muscles of the lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); ten minutes isometric and dynamic exercises with elastic (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); twenty minutes away from aerobic exercise (stationary running deep water running); ten minutes in functional training step and proprioceptive exercises; and five minutes of cooling with stretching of muscles of lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings).
Both groups will receive guidance home exercises two to three times a week, and reinforced by familiar previously illustrated booklets, which include the same goals of aquatic exercises: heating, self stretching of the lower limb muscles, isometric and dynamic exercises of the lower limbs , proprioceptive and functional exercises, aerobic exercises is relaxation.
Three months after the end of intervention protocols, ie, at the end of follow-up, patients in the group Education will be invited to perform aquatic therapy and patients in group aquatic therapy will receive the manual of educational guidelines.
- Conditions
- Osteoarthritis
- Being tested
- Patient Education, Aquatic Physical Therapy
- Keywords
- Osteoarthritis, Patient Education, Aquatic Exercise, kinetic
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
Also called Health Education
The educational program will comprise a multidisciplinary team: doctor, pharmacist, nurse, nutritionist, psychologist, physiotherapist and physical educator. Classes will be weekly in groups for eight weeks, with a duration of two hours.
The education program will include the following items: guidelines about the disease and its complications, strategies for pain management (pharmacological and cognitive), physical exercise, nutrition and weight control, medication (type, interactions, current trends, side effects ), balance, proprioception, fall prevention, coping with chronic pain.
Aquatic Physical TherapyOther
Also called Aquatic Exercise
The exercise protocol will consist of: five minutes of heating with walking and patellar mobilization; ten minutes stretching the muscles of the lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); ten minutes isometric and dynamic exercises with elastic (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); twenty minutes away from aerobic exercise (stationary running deep running water); ten minutes in functional training step and proprioceptive exercises; and five minutes of cooling with stretching of muscles of lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings).
| Study group | Role | What they receive |
|---|---|---|
| Patient Education | Experimental | Health Education. Receives: Other: Patient Education |
| Aquatic Physical Therapy | Active comparator | Protocol of aquatic physical therapy exercises. Receives: Other: Aquatic Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Evaluation of pain - EVA
Measured: up to 3 months
Secondary outcomes (4)
Function
Physical Function - WOMAC Index
Measured: 2 and 3 months
Balance
ABC Scale and postural balance
Measured: 2 and 3 months
Quality Of Live
SF-36 Questionaire
Measured: 2 and 3 months
kinetic
Ground Reaction Forces and postural balance
Measured: 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fundação Araucária
- Responsible party
- Principal investigator, Jefferson Rosa Cardoso, Universidade Estadual de Londrina
- Investigators
- Ligia M Facci, PT, PhD, Principal investigator, Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247882
- Sponsor's protocol ID
- RCTOA14
- Other IDs
- 1406
- Acronym
- RCT-OA
- Status last verified
- May 2017
- First submitted
- 21 Sep 2014
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lyytinen T, Liikavainio T, Bragge T, Hakkarainen M, Karjalainen PA, Arokoski JP. Postural control and thigh muscle activity in men with knee osteoarthritis. J Electromyogr Kinesiol. 2010 Dec;20(6):1066-74. doi: 10.1016/j.jelekin.2010.05.005. Epub 2010 Jun 11.
PubMed 20541439Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Fernandes MI. Tradução e validação do questionário de qualidade de vida específico para osteoartrose WOMAC (Western Ontario McMasterUniversities) para a língua portuguesa. São Paulo, 2002. 103p. Tese de Mestrado - Universidade Federal de São Paulo - Escola Paulista de Medicina - Reumatologia.
Marques AP, Mendes YC, Taddei U, Pereira CA, Assumpcao A. Brazilian-Portuguese translation and cross cultural adaptation of the activities-specific balance confidence (ABC) scale. Braz J Phys Ther. 2013 Mar-Apr;17(2):170-8. doi: 10.1590/S1413-35552012005000072.
PubMed 23778771Duarte M, Freitas SMSF. Revisão sobre posturografia baseada em plataforma de força para avaliação do equilíbrio. Rev Bras Fisioter, São Carlos, v. 14, n. 3, p. 183-92, maio/jun. 2010.
CICONELLI RM, FERRAZ MB, SANTOS W, MEINÃO I, QUARESMA MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação da qualidade de vida SF-36 (Brasil SF-36).RevBrasreumatol 1999; 39(3): 143-150.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Education Compared to Aquatic Physical Therapy for Patients With Knee Osteoarthritis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02247882
- Acronym / sponsor ID
- RCT-OA / RCTOA14
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Patient Education, Aquatic Exercise, kinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fundação Araucária
- Study start
- Feb 2015 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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 purpose of this study is to determine whether education or aquatic physical therapy are effective in the treatment of osteoarthritis in Knee due to intensity of pain, function capacity, quality of life and kinetic.
Detailed description
Sixty patients will be recruited from clinics and through printed newspaper. Physicians who routinely evaluate patients with this diagnosis will be informed of the study, and the same will be announced by television call.
After passing a medical examination confirming the clinical diagnosis of knee osteoarthritis by American College of Rheumatology and other criteria, the elect will be informed of the objectives of the study and invited to participate.
After evaluation of the records of referrals of knee OA, patients receive phone calls, will be informed of the research objectives, questioned regarding the inclusion and exclusion criteria of the study and invited to participate in the study.
Upon study entry, personal information (name, age, gender, address and telephone) will be confirmed by a secretary, who will give the registration number of the patient. Personal information, as well as their radiographs, will be kept in personal form, with number of study enrollment.
Before and after implementation of treatment protocols, as well as after three months, all patients will be assessed by an independent examiner, ie, that have no knowledge about the intervention with respect to different variables. The independent examiner will have been previously trained for this role to become fit to do so.
Individuals will be assessed using the rubric for the outcomes of pain intensity using a Visual Analogue Scale (VAS); functional capacity of the Western Ontario and McMaster Universities Index (WOMAC); balance the Activities-specific Balance Confidence (ABC) and by static posturography and reaction forces to the ground by static force platform. Body weight will be checked by portable scale; height, and waist circumference with tape measure to calculate BMI.
After evaluation, patients will be divided by the numbers generated by the computer through the site (www.random.org) in both treatment groups with 30 patients. After the generation of numbers, they will be transformed into a card with the assigned treatment (1- Patient Education; 2 Aquatic Physiotherapy) and then placed in sealed, opaque, sequentially numbered envelopes. Thus, it prevented the evaluator and the therapist choose the group to which the patient is assigned. Procedures for randomization and allocation, as well as assessments and interventions will be blinded.
The educational program will comprise a multidisciplinary team: doctor, pharmacist, nurse, nutritionist, psychologist, physiotherapist and physical educator. Classes will be weekly in groups for eight weeks, lasting two hours, to be held in the Parlor of Our Lady of Grace Church, belonging to the scope of the Health Unit Vila Brazil.
The program will include education, following the suggestions of Coleman et al. the following items: guidelines about the disease and its complications, strategies for pain management (pharmacological and cognitive), physical exercise, nutrition and weight control, medication (type, interactions, current trends, side effects), balance, proprioception , fall prevention, coping with chronic pain. Following, practical activities on the themes will be addressed.
To enhance the information at the end, patients will receive printed material with the guidelines given by the professional. Still, the first and last day of the education program, patients will respond a questionnaire addressing their knowledge about the disease developed by the researchers.
Supervised aquatic exercise will run individually, twice a week, lasting 60 minutes, for eight weeks, totaling 16 sessions at the Center for Aquatic Physical Therapy Professor Paulo Armindo Seibert, Universidade Estadual de Londrina. The water temperature will be maintained at approximately 32 degrees, with a depth of 1.20m. The exercise protocol will consist of: five minutes of heating with walking and patellar mobilization; ten minutes stretching the muscles of the lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); ten minutes isometric and dynamic exercises with elastic (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); twenty minutes away from aerobic exercise (stationary running deep water running); ten minutes in functional training step and proprioceptive exercises; and five minutes of cooling with stretching of muscles of lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings).
Both groups will receive guidance home exercises two to three times a week, and reinforced by familiar previously illustrated booklets, which include the same goals of aquatic exercises: heating, self stretching of the lower limb muscles, isometric and dynamic exercises of the lower limbs , proprioceptive and functional exercises, aerobic exercises is relaxation.
Three months after the end of intervention protocols, ie, at the end of follow-up, patients in the group Education will be invited to perform aquatic therapy and patients in group aquatic therapy will receive the manual of educational guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education | Experimental | Other: Patient EducationHealth Education. |
| Aquatic Physical Therapy | Active comparator | Other: Aquatic Physical TherapyProtocol of aquatic physical therapy exercises. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged between 60 and 85 years;
- patients with knee OA by a physician confirmed by the criteria of American College of Rheumatology;
- patients with clinical and cognitive activities for the realization of the pool conditions, confirmed by the Mini-Exam Mental state.
Key exclusion criteria (9 listed)
- patients undergoing surgical procedures in the last six months;
- patients with chronic diseases such as coronary, other rheumatic diseases such as rheumatoid arthritis; serious diseases such as cancer; chronic obstructive pulmonary diseases; uncontrolled hypertensive;
- patients unable to walk without aid equipment;
- patients who have contraindications to practice exercises;
- patients who have contraindications for entry into the pool, such as urinary or fecal incontinence and skin problems;
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 |
|---|---|---|
| Patient EducationAlso: Health EducationThe educational program will comprise a multidisciplinary team: doctor, pharmacist, nurse, nutritionist, psychologist, physiotherapist and physical educator. Classes will be weekly in groups for eight weeks, with a duration of two hours. The education program will include the following items: guidelines about the disease and its complications, strategies for pain management (pharmacological and cognitive), physical exercise, nutrition and weight control, medication (type, interactions, current trends, side effects ), balance, proprioception, fall prevention, coping with chronic pain. | Other | Patient Education |
| Aquatic Physical TherapyAlso: Aquatic ExerciseThe exercise protocol will consist of: five minutes of heating with walking and patellar mobilization; ten minutes stretching the muscles of the lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); ten minutes isometric and dynamic exercises with elastic (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); twenty minutes away from aerobic exercise (stationary running deep running water); ten minutes in functional training step and proprioceptive exercises; and five minutes of cooling with stretching of muscles of lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings). | Other | Aquatic Physical Therapy |
Primary outcome
Pain
Time frame: up to 3 months
Evaluation of pain - EVA
4 secondary outcomes
Function
Time frame: 2 and 3 months
Balance
Time frame: 2 and 3 months
Quality Of Live
Time frame: 2 and 3 months
kinetic
Time frame: 2 and 3 months
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 25 May 2017.
- Background: PubMed 20541439Lyytinen T, Liikavainio T, Bragge T, Hakkarainen M, Karjalainen PA, Arokoski JP. Postural control and thigh muscle activity in men with knee osteoarthritis. J Electromyogr Kinesiol. 2010 Dec;20(6):1066-74. doi: 10.1016/j.jelekin.2010.05.005. Epub 2010 Jun 11.
- Background: PubMed 6226917Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
- BackgroundFernandes MI. Tradução e validação do questionário de qualidade de vida específico para osteoartrose WOMAC (Western Ontario McMasterUniversities) para a língua portuguesa. São Paulo, 2002. 103p. Tese de Mestrado - Universidade Federal de São Paulo - Escola Paulista de Medicina - Reumatologia.
- Background: PubMed 23778771Marques AP, Mendes YC, Taddei U, Pereira CA, Assumpcao A. Brazilian-Portuguese translation and cross cultural adaptation of the activities-specific balance confidence (ABC) scale. Braz J Phys Ther. 2013 Mar-Apr;17(2):170-8. doi: 10.1590/S1413-35552012005000072.
- BackgroundDuarte M, Freitas SMSF. Revisão sobre posturografia baseada em plataforma de força para avaliação do equilíbrio. Rev Bras Fisioter, São Carlos, v. 14, n. 3, p. 183-92, maio/jun. 2010.
- BackgroundCICONELLI RM, FERRAZ MB, SANTOS W, MEINÃO I, QUARESMA MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação da qualidade de vida SF-36 (Brasil SF-36).RevBrasreumatol 1999; 39(3): 143-150.
- Individual participant dataSharing planned: Yes
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Ligia M Facci, PT, PhD principal investigator
Adjunct Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education and Aquatic Physical Therapy in people with Osteoarthritis, run by Universidade Estadual de Londrina at 1 site in Brazil.
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 25 May 2017. 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 Brazil. 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?
Pain (time frame: up to 3 months). 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 NCT02247882, which also lists 6 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 25 May 2017.