Knee OsteoarthritisPhase 4NCT02829281
Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis
A Phase 4 study testing Botulinum Toxin Type A, Triamcinolone hexacetonide and Saline in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Introduction: Osteoarthritis of the knee is a very common disease. However there are few treatment options for these patients. Botulinum toxin type A is an option for chronic pain. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Botulinum Toxin Type A, Triamcinolone hexacetonide and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to Dec 2016
- Phase
- Phase 4
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age above 50 years
- diagnose of knee osteoarthritis using clinics and radiographic criteria
- pain for more than 6 months
- analogic visual scale among 4 to 8
- patients who agree to sign informed consent
Who cannot join
- secondary osteoarthritis
- skin lesion
- use of intraarticular corticosteroid in the last 3 months
- use of oral corticosteroid in the last 30 days
- Kellgren Lawrence I or IV
- inflammatory arthritis
Show all 15Show fewer
- neuromuscular disease
- use of aminoglycoside antibiotics
- metalic prosthesis in knee
- peripheric neuropathy
- serious cardiovascular or pulmonary disease
- serious disorder of coagulation
- pregnancy or breastfeeding
- infections
- use of wheelchair
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Sao Paulo
São Paulo, São Paulo, 04023-900
About this study
Official title: Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees
Introduction: Osteoarthritis of the knee is a very common disease. However there are few treatment options for these patients. Botulinum toxin type A is an option for chronic pain. If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum toxin type A can be useful for treat these patients.
Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus Botulinum toxin type A in the treatment of patients with knee osteoarthritis.
Methods: A prospective controlled randomized double blind studied with three groups (n = 35 each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular medication in a single moment will be undertaken. The three groups will be: Botulinum toxin type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators " blind " in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain, quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures . Will be considered as statistical significance the difference of 5 %.
- Conditions
- Knee Osteoarthritis
- Being tested
- Botulinum Toxin Type A, Triamcinolone hexacetonide, Saline
- Keywords
- knee osteoarthritis, Intra-articular injection, Botulinum Toxin Type A, Corticosteroid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joint injection of Botulinum Toxin Type A
Triamcinolone hexacetonideDrug
Joint injection of triamcinolone hexacetonide
SalineDrug
Joint injection of Saline
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin group | Experimental | Patients will receive a intervention with joint injection of 100 units of botulinum toxin Receives: Drug: Botulinum Toxin Type A |
| Corticosteroid group | Active comparator | Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid) Receives: Drug: Triamcinolone hexacetonide |
| Saline Group | Placebo comparator | Patients will receive a joint injection of 2ml of normal saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Pain
Evaluated using the visual analogue scale
Measured: Baseline, after 4, 8 and 12 weeks
Secondary outcomes (3)
Changes on Ultrasound parameters
quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler
Measured: Baseline, after 4, 8 and 12 weeks
Changes on quality of life
Evaluated using the Short form 36 questionnaire
Measured: Baseline, after 4, 8 and 12 weeks
Changes on function
Evaluated using the WOMAC questionnaire
Measured: Baseline, after 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamille Godoy Mendes, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829281
- Sponsor's protocol ID
- CEP UNIFESP - 319915
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Botulinum Toxin Type A Versus Corticosteroids: a Clinical Trial in Osteoarthritis of Knees
- ClinicalTrials.gov ID
- NCT02829281
- Acronym / sponsor ID
- CEP UNIFESP - 319915
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, Intra-articular injection, Botulinum Toxin Type A, Corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Jul 2016 (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.
Introduction: Osteoarthritis of the knee is a very common disease. However there are few treatment options for these patients. Botulinum toxin type A is an option for chronic pain. If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum toxin type A can be useful for treat these patients.
Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus Botulinum toxin type A in the treatment of patients with knee osteoarthritis.
Methods: A prospective controlled randomized double blind studied with three groups (n = 35 each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular medication in a single moment will be undertaken. The three groups will be: Botulinum toxin type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators " blind " in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain, quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures . Will be considered as statistical significance the difference of 5 %.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin group | Experimental | Drug: Botulinum Toxin Type APatients will receive a intervention with joint injection of 100 units of botulinum toxin |
| Corticosteroid group | Active comparator | Drug: Triamcinolone hexacetonidePatients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid) |
| Saline Group | Placebo comparator | Drug: SalinePatients will receive a joint injection of 2ml of normal saline |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age above 50 years
- diagnose of knee osteoarthritis using clinics and radiographic criteria
- pain for more than 6 months
- analogic visual scale among 4 to 8
- patients who agree to sign informed consent
Key exclusion criteria (15 listed)
- secondary osteoarthritis
- skin lesion
- use of intraarticular corticosteroid in the last 3 months
- use of oral corticosteroid in the last 30 days
- Kellgren Lawrence I or IV
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 |
|---|---|---|
| Botulinum Toxin Type AJoint injection of Botulinum Toxin Type A | Drug | Botulinum toxin group |
| Triamcinolone hexacetonideJoint injection of triamcinolone hexacetonide | Drug | Corticosteroid group |
| SalineJoint injection of Saline | Drug | Saline Group |
Primary outcome
Changes on Pain
Time frame: Baseline, after 4, 8 and 12 weeks
Evaluated using the visual analogue scale
3 secondary outcomes
Changes on Ultrasound parameters
Time frame: Baseline, after 4, 8 and 12 weeks
Changes on quality of life
Time frame: Baseline, after 4, 8 and 12 weeks
Changes on function
Time frame: Baseline, after 4, 8 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A, Triamcinolone hexacetonide and Saline in people with Knee Osteoarthritis, run by Federal University of São Paulo 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 12 Jul 2016. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamille G Mendes, MD (551155764239, jamillegmendes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on Pain (time frame: Baseline, after 4, 8 and 12 weeks). 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 12 Jul 2016.