Botox, Hyaluronic Acid, Intraarticular Injection, Knee Osteoarthritis
Conditions
Brief summary
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
DRUGHyaluronic acid
Patients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.
DRUGBotulinum 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 3 months after the interventions | Each patient will be instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of quality of life | 3 months after the interventions | 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. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 3 months after the interventions | 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). |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 3 months after the interventions | 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. |
Countries
Egypt
Contacts
CONTACTMohammed S ElSharkawy, MD
Outcome results
None listed