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

Not Applicable

Completed

• Conditions: Intraarticular; Ozone; Prolotherapy; Dexmedetomidine; Pain; Knee Osteoarthritis
• Interventions: Drug: Ozone; Drug: Dextrose prolotherapy; Drug: Dexmedetomidine

• Registration Number: NCT06909305
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Osteoarthritis (OA) is a heterogeneous group of disorders of different etiologies with similar biological, morphological, and clinical manifestations and outcomes. The intraarticular injection has been recommended to alleviate the pain in the knee joint.

Ozone therapy has long been used in the management of OA. Furthermore, it has been shown to not cause a significant inflammation process or cartilage degradation. Prolotherapy is a procedure where a natural irritant is injected into the soft tissue of an injured joint. Dexmedetomidine is a selective α2-adrenergic agonist with considerable sedative and analgesic actions.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozone group	Ozone	Patients received intraarticular ozone injection.
Dextrose prolotherapy group	Dextrose prolotherapy	Patients received intraarticular dextrose prolotherapy injection.
Dexmedetomidine group	Dexmedetomidine	Patients received intraarticular dexmedetomidine injection.

Primary Outcome Measures

Name	Time	Method
Analgesic requirement	3 months after the procedure	Analgesic requirements for pain control after injection were recorded.

Secondary Outcome Measures

Name	Time	Method
Improvement of lifestyle	3 months after the procedure	Improvement of lifestyle was assessed using the Western Ontario Mac Master Osteoarthritis Index (WOMAC-OI) scale. The Likert type of the WOMAC Persian version was employed in this paper. The Persian version is a dependable and uncomplicated procedure that provides five responses: extreme (4), severe (3), moderate (2), mild (1), and none (0). The patients' stiffness, pain, and functional restriction are all represented by the higher scores.
Improvement of knee joint cartilage regeneration	3 months after the procedure	Improvement of knee joint cartilage regeneration was assessed using the Kellgren-Lawrence Classification System (K-L). K-L: which categorize knee OA into four stages based on radiological findings: Grade 4 (severe): Marked joint space narrowing, large osteophytes, severe sclerosis, and definite deformity of bone ends. Grade 3 (moderate): Moderate multiple osteophytes, some sclerosis, definite joint space narrowing, and potential deformity of bone ends. Grade 2 (minimal): Definite osteophytes and potential joint space narrowing. Grade 1 (doubtful): Possible osteophytic lipping and doubtful joint space narrowing.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt