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

Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis: A Randomized Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909305
Enrollment
60
Registered
2025-04-03
Start date
2022-10-01
Completion date
2023-10-01
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraarticular, Ozone, Prolotherapy, Dexmedetomidine, Pain, Knee Osteoarthritis

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.

Interventions

DRUGOzone

Patients received intraarticular ozone injection.

Patients received intraarticular dextrose prolotherapy injection.

DRUGDexmedetomidine

Patients received intraarticular dexmedetomidine injection.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analgesic requirement3 months after the procedureAnalgesic requirements for pain control after injection were recorded.

Secondary

MeasureTime frameDescription
Improvement of lifestyle3 months after the procedureImprovement 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 regeneration3 months after the procedureImprovement 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026