Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

NCT02829281 | Unknown Phase 4

• 1 other identifier: CEP UNIFESP - 319915
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

knee osteoarthritis; Intra-articular injection; Botulinum Toxin Type A; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Changes on Pain

  Evaluated using the visual analogue scale

  Baseline, after 4, 8 and 12 weeks

Secondary Outcomes (3)

• Changes on Ultrasound parameters

  Baseline, after 4, 8 and 12 weeks

• Changes on quality of life

  Baseline, after 4, 8 and 12 weeks

• Changes on function

  Baseline, after 4, 8 and 12 weeks

Study Arms (3)

Botulinum toxin group

EXPERIMENTAL

Patients will receive a intervention with joint injection of 100 units of botulinum toxin

Drug: Botulinum Toxin Type A

Corticosteroid group

ACTIVE COMPARATOR

Patients will receive a intervention with joint injection of 40mg of triamcinolone hexacetonide (corticosteroid)

Drug: Triamcinolone hexacetonide

Saline Group

PLACEBO COMPARATOR

Patients will receive a joint injection of 2ml of normal saline

Drug: Saline

Interventions

Botulinum Toxin Type A DRUG

Joint injection of Botulinum Toxin Type A

Botulinum toxin group

Triamcinolone hexacetonide DRUG

Joint injection of triamcinolone hexacetonide

Corticosteroid group

Saline DRUG

Joint injection of Saline

Saline Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Botulinum Toxins, Type A; triamcinolone hexacetonide; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Jamille G Mendes, MD

CONTACT

551155764239; jamillegmendes@gmail.com

Rita NV Furtado, MD

CONTACT

1155764239; rvfurtado@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 12, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

BR (1)