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

NCT ID: NCT06909305

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraarticular Ozone Prolotherapy Dexmedetomidine Pain Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ozone group

Patients received intraarticular ozone injection.

Group Type EXPERIMENTAL

Ozone

Intervention Type DRUG

Patients received intraarticular ozone injection.

Dextrose prolotherapy group

Patients received intraarticular dextrose prolotherapy injection.

Group Type EXPERIMENTAL

Dextrose prolotherapy

Intervention Type DRUG

Patients received intraarticular dextrose prolotherapy injection.

Dexmedetomidine group

Patients received intraarticular dexmedetomidine injection.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Patients received intraarticular dexmedetomidine injection.

Interventions

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Ozone

Patients received intraarticular ozone injection.

Intervention Type DRUG

Dextrose prolotherapy

Patients received intraarticular dextrose prolotherapy injection.

Intervention Type DRUG

Dexmedetomidine

Patients received intraarticular dexmedetomidine injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Abd El-Wahab Saif El-Dien

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Tanta, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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35148/12/21

Identifier Type: -

Identifier Source: org_study_id

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