Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis

NCT06909305 | Completed

• 1 other identifier: 35148/12/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare intraarticular ozone injection, prolotherapy, or dexmedetomidine effectiveness in knee osteoarthritis patients.

Conditions

Intraarticular; Ozone; Prolotherapy; Dexmedetomidine; Pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Analgesic requirement

  Analgesic requirements for pain control after injection were recorded.

  3 months after the procedure

Secondary Outcomes (2)

• Improvement of lifestyle

  3 months after the procedure

• Improvement of knee joint cartilage regeneration

  3 months after the procedure

Study Arms (3)

Ozone group

EXPERIMENTAL

Patients received intraarticular ozone injection.

Drug: Ozone

Dextrose prolotherapy group

EXPERIMENTAL

Patients received intraarticular dextrose prolotherapy injection.

Drug: Dextrose prolotherapy

Dexmedetomidine group

EXPERIMENTAL

Patients received intraarticular dexmedetomidine injection.

Drug: Dexmedetomidine

Interventions

Ozone DRUG

Patients received intraarticular ozone injection.

Ozone group

Dextrose prolotherapy DRUG

Patients received intraarticular dextrose prolotherapy injection.

Dextrose prolotherapy group

Dexmedetomidine DRUG

Patients received intraarticular dexmedetomidine injection.

Dexmedetomidine group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 30 to 65 years.
• Both genders.
• Patients diagnosed with stage 1-3 osteoarthritis according to the Kellgren-Lawrence Classification System (K-L).

You may not qualify if:

• Patient refusal.
• History of knee trauma within the past month.
• Rheumatic disease.
• Pregnancy.
• Any surgical intervention of the knee.
• Severe cardiovascular disease.
• Morbid obese patients (body mass index (BMI) of \>35 kg/m2).
• Local infection at the site of injection.
• Bleeding diathesis.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain; Osteoarthritis, Knee

Interventions

Ozone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 3, 2025

Record last verified: 2025-03

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)