Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorTanta University
About this trial
This study aims to compare the efficacy of intra-articular injection of Botulinum toxin and hyaluronic acid on pain in knee osteoarthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic acid
DrugPatients will be given intra-articular injection of 2 ml of hyaluronic acid into the joint space three times weekly.
Botulinum toxin type A
DrugPatients will be given intra-articular injection of 100 units of Botulinum toxin type A, diluted with 5 ml of normal saline three times weekly.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Group HAExperimental treatment 1 intervention
Group B: Group BTXExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 interventionsSecondary outcomes
1
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 interventions2
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 interventions3
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 interventionsSponsors and contacts
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Source ClinicalTrials.gov