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Effects of intraarticular infiltration in rheumatoid arthritis women´s knees

Effects of Intraarticular Infiltration of Triamcinolone Hexacetonide in Rheumatoid Arthritis women´s knees on static, functional and inflammatory activity measurements: a randomized, controlled, blinded clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4g4sk8
Enrollment
Unknown
Registered
2018-06-06
Start date
2017-01-24
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

Experimental group: 20 women with rheumatoid arthritis will receive intra-articular infiltration with 3 ml of triamcinolone hexacetonide in the knee. Control group: 20 women will receive 3ml of saline
Drug
D04.808.745.432.915

Sponsors

Universidade Estadual Paulista - UNESP
Lead Sponsor
Faculdade de Medicina de Marília
Collaborator
Universidade Estadual Paulista - UNESP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of RA according to the American College of Rheumatology (ACR) Classification Criteria of 1987 or Classification Criteria for RA 2010 of the ACR / EULAR; Age over 18 years; Female gender; Analog Visual Scale (EVA) of knee pain between 40 and 80 mm; EVA of knee edema between 40 and 80 mm; Be stable with drugs modifying the course of the disease in the last 3 months and / or oral corticosteroids in the last month; Presence of refractory knee injury in the last 3 months.

Exclusion criteria

Exclusion criteria: Injury and / or diseases symptomatic knee than RA; radiographic classification of Kellgren-Lawrence grade IV; Knee prosthesis in the target joint; prior realization of any IIAC in the last 6 months; Symptoms of systemic or local infection; reported hypersensitivity to the drug components or contraindication to the use thereof;Suspected or confirmed pregnancy; Physical therapy or other treatment in parallel to symptom in knee; Uncontrolled systemic arterial hypertension; Previous knee surgery to be evaluated; Skin lesions at the IIA site; Deficit vision or hearing or cognitive preventing the completion of the evaluations proposed.

Design outcomes

Primary

MeasureTime frame
Improvement of the muscular strength of knee extensors after IIA verified by means of a load cell from the observation of a variation of at least 10% in the pre and post intervention measurements

Secondary

MeasureTime frame
Improvement of pain and edema assessed through visual analogue scale; Improvement of functionality assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), Lequesne's Algofunctional Questionnaire, 30-s chair-stand test , and Timed Up and Go Test; Improvement of range of motion assessed by computerized photogrammetry

Countries

Brazil

Contacts

Public ContactMariana Lourenço

Universidade Estadual Paulista - UNESP

maalmeida1@terra.com.br+55 (14) 98119 6170

Outcome results

None listed

Source: REBEC (via WHO ICTRP)