- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06641206
Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain
October 11, 2024 updated by: Ahmed ElKashef, Tanta University
Intra-articular Dexmedetomidine for Treatment of Chronic Knee Pain: A Prospective Case-Control Clinical Trial
Chronic knee osteoarthritis (KOA) is a painful condition with limited treatment options.
Non-pharmacological approaches often fall short, leading to decreased quality of life.
Ozone therapy, a simple and affordable treatment, has shown promise for pain relief.
Dexmedetomidine (DEX), a sedative and analgesic, has been used successfully as an adjuvant to anesthesia and local anesthetics.
Given its potential for pain management, exploring DEX as a treatment for KOA could offer a new and promising approach.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
El Gharbyia
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Tanta, El Gharbyia, Egypt, 13511
- Recruiting
- Tanta University
-
Contact:
- Ali El Deeb, Professor
- Phone Number: +2 01222800335
- Email: b.checked88@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients were not assigned for surgical intervention;
- Patients were free of exclusion criteria
Exclusion Criteria:
- Patients were assigned for surgical intervention;
- Patients who had uncontrolled hypertension and/or diabetes mellitus;
- Patients who had uncompensated cardiac, renal, or hepatic diseases;
- Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
- Patients who refused to sign the informed consent were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
A group of Patients from Tanta University suffering from Chronic painful knee osteoarthritis who didn't receive medical treatment and progressed to have chronic pain with decreased physical function and poorer quality of life.
|
1 ml of triamcinolone acetonide was used to prepare a solution for knee injection for patients with Chronic Knee Pain
20mg of bupivacaine hydrochloride was used to prepare a solution for knee injection for patients with Chronic Knee Pain
|
|
Active Comparator: Group 2
A group of Patients from Tanta University suffering from Chronic painful knee osteoarthritis who didn't receive medical treatment and progressed to have chronic pain with decreased physical function and poorer quality of life.
|
Dexmedetomidine solution was prepared by mixing Dexmedetomidine in a dose of 3 µg/kg in 5-ml saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-intra-articular Injection.
Time Frame: 7 months
|
Value of intra-articular Injection in Pain Reduction of chronic knee pain manifested by recurrence of pain.
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2024
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
October 11, 2024
First Submitted That Met QC Criteria
October 11, 2024
First Posted (Actual)
October 15, 2024
Study Record Updates
Last Update Posted (Actual)
October 15, 2024
Last Update Submitted That Met QC Criteria
October 11, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Local
- Dexmedetomidine
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
- Bupivacaine
Other Study ID Numbers
- 36264PR843/9/24
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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