Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyaluronic acid, Botulinum toxin type A.
- Who it may be relevant to
- Registry conditions: Intraarticular Injection, Botox, Hyaluronic Acid, Knee Osteoarthritis. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is a widespread musculoskeletal disease and a leading cause of chronic disability. Conservative estimates state that up to 240 million people worldwide suffer from it. Knee osteoarthritis (KOA) is associated with chronic inflammation that causes persistent oxidative damage, which subsequently leads to joint degeneration.
Therefore, intra-articular (IA) therapies might be an alternative and safe treatment for these patients.
IA injection of hyaluronic acid (HA) is still a controversial treatment for knee osteoarthritis and comparative studies of HA versus more established treatments are warranted.
Botulinum toxin (BTX), produced by the bacterium Clostridium botulinum, acts on both sensory and motor neurons. Irreversible binding of BTX to presynaptic receptors of motor endplates inhibits acetylcholine release.
Interventions
- Drug Hyaluronic acid
Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly. - Drug Botulinum toxin type A
Patients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly.
Primary outcome measures
- Degree of pain [Time frame: 3 months after the interventions]
Secondary outcome measures (3)
- Assessment of quality of life [Time frame: 3 months after the interventions]
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Time frame: 3 months after the interventions]
- Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: 3 months after the interventions]
Eligibility criteria
Inclusion criteria
- Age ≥ 50 years.
- Both genders.
- Chronic knee osteoarthritis (KOA) according to American College of Rheumatology criteria for the diagnosis of knee osteoarthritis.
- Third or fourth grade Kellgren and Lawrence system for classification of osteoarthritis based on radiological data, it is a common method of classifying the severity of osteoarthritis (OA) using five grades according to the following sites and projections.
Exclusion criteria
- History of intra-articular injection within the last 6 months,
- History of surgery on the knee joint or major trauma to the lower limb causing fracture.
- Body mass index (BMI) more than 40 kg/m2.
- Medical conditions affecting the joint or lower extremity function such as severe osteoporosis, rheumatoid arthritis, collagen vascular diseases, and gout.
- Diabetic patient.
- Any contraindication to intra-articular injections for instance immunodeficiency, coagulation defect or anticoagulation therapy taking or skin infection at the site of injection.
- Hypersensitivity to Botulinum toxin or hyaluronic acid.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07666347 · 36265PR78/5/26