Intraarticular Injection of Botox and Hyaluronic Acid in Knee Osteoarthritis

NCT07666347 | Recruiting

• 1 other identifier: 36265PR78/5/26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraarticular Injection; Botox; Hyaluronic Acid; Knee Osteoarthritis

Outcome Measures

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").

  3 months after the interventions

Secondary Outcomes (3)

• Assessment of quality of life

  3 months after the interventions

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  3 months after the interventions

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  3 months after the interventions

Study Arms (2)

Group HA

EXPERIMENTAL

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

Drug: Hyaluronic acid

Group BTX

EXPERIMENTAL

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.

Drug: Botulinum toxin type A

Interventions

Hyaluronic acid DRUG

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

Group HA

Botulinum toxin type A DRUG

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.

Group BTX

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Mohammed S ElSharkawy, MD

CONTACT

00201148207870; mselsharkawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lect urer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: June 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)