Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis

Tanta University50 enrolled

Overview

This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Intraarticular Injection Botox Hyaluronic Acid Knee Osteoarthritis

Interventions

Hyaluronic acidDRUG

Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.

Botulinum toxin type ADRUG

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Degree of pain

Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").

Time frame: 3 months after the interventions

Secondary Outcomes

Assessment of quality of life

The Short form (SF)-36 generic quality of life questionnaire, which is composed of eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects, and mental health.

Time frame: 3 months after the interventions

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) which is a specific functional questionnaire that assesses pain (5 subitems), stiffness (2 items), and function (17 items).

Time frame: 3 months after the interventions

Knee Injury and Osteoarthritis Outcome Score (KOOS)

The Knee Injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes, Pain (nine items); Symptoms (seven items); Activities of Daily Living Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.

Time frame: 3 months after the interventions

Central Contacts

Mohammed S ElSharkawy, MD

CONTACT

00201148207870 mselsharkawy@med.tanta.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.