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NCT Number: NCT06909305

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

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

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Key information

Conditions

Intraarticular Arthritis Dexmedetomidine Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Ozone Pain Pathological Conditions, Signs and Symptoms Prolotherapy Rheumatic Diseases Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozone

Drug

Patients received intraarticular ozone injection.

Dextrose prolotherapy

Drug

Patients received intraarticular dextrose prolotherapy injection.

Dexmedetomidine

Drug

Patients received intraarticular dexmedetomidine injection.

Primary outcomes

  1. Analgesic requirement

    Time frame: 3 months after the procedure

    Analgesic requirements for pain control after injection were recorded.

Secondary outcomes

  1. Improvement of lifestyle

    Time frame: 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.

  2. Improvement of knee joint cartilage regeneration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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