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An Investigation into the Efficacy of Intra-articular Injection of Botulinium Toxin versus Steroid on Pain and Function of Patients with Knee Osteoarthritis

An Investigation into the Efficacy of Intra-articular Injection of Botulinium Toxin versus Steroid on Pain and Function of Patients with Knee Osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017103013442N20
Enrollment
40
Registered
2017-11-12
Start date
2017-09-23
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

knee osteoarthritis. Gonarthrosis [arthrosis of knee]

Interventions

Intervention 1: Intervention group 1: Botulinium toxin, knee intraarticuar injection, half of 500-IU vial, a single injection. Intervention 2: Intervention group 2: Triamcinolone acetonide, knee intra
Treatment - Drugs
Intervention group 1: Botulinium toxin, knee intraarticuar injection, half of 500-IU vial, a single injection
Intervention group 2: Triamcinolone acetonide, knee intraarticuar injection, 1cc of 40mg/ml vial, a single injection

Sponsors

Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion critetia: Confirmed knee-osteoarthritis patients based on American College of Rheumatology (ACR) criteria with ages ranging from 40 to 75 years; more than 3 months symptoms resistant despite the conservative treatment; grade 2 or 3 according to KLS system in plain x-ray film. Exclusion criteria: Infection and active wound in knee; Gout or psudogout; neuromuscular illnesses; Pregnancy or breast-feeding; any history of intra articular injection over the past 3 months; Acute trauma of knee; Recent physiotherapy during last 3 months; Genuvarum or valgum more than 20 degrees; Radioculophathy; BMI=35; Hx of allergy to Botulinium Toxin; Systemic illnesses like diabetes melitus, immunodeficiency, and vascular collagen diseaes; prior history of cancer or active malignant lesions; ages below 40 years or above 75 years.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Knee Pain. Timepoint: Before intervention and 8 & 24 weeks after injection. Method of measurement: WOMAC questionnaire.

Secondary

MeasureTime frame
Pain. Timepoint: Before intervention and 8 & 24 weeks after injection. Method of measurement: VAS questionnaire.;Joint Stiffness. Timepoint: Before intervention and 8 & 24 weeks after injection. Method of measurement: WOMAC questionnaire.;Patient Function. Timepoint: Before intervention and 8 & 24 weeks after injection. Method of measurement: WOMAC questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan Enayati

Physical Medicine and Rehabilitation Department, Shahid Beheshti University of Medical Sciences, Sch

dr.enayati1984@gmail.com+98 21 2273 1112

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026