Chronic Knee PainNCT06641206
Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain
A study testing Triamcinolone Acetonide, Bupivacaine Hydrochloride and Dexmedetomidine in people with Chronic Knee Pain, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- Triamcinolone Acetonide, Bupivacaine Hydrochloride and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were not assigned for surgical intervention;
- Patients were free of exclusion criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El Gharbyia, 13511
Ali El Deeb, Professor, 01222800335 ext. +2, b.checked88@gmail.com
About this study
Official title: 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.
- Conditions
- Chronic Knee Pain
- Being tested
- Triamcinolone Acetonide, Bupivacaine Hydrochloride, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
1 ml of triamcinolone acetonide was used to prepare a solution for knee injection for patients with Chronic Knee Pain
Bupivacaine HydrochlorideDrug
20mg of bupivacaine hydrochloride was used to prepare a solution for knee injection for patients with Chronic Knee Pain
DexmedetomidineDrug
Dexmedetomidine solution was prepared by mixing Dexmedetomidine in a dose of 3 µg/kg in 5-ml saline
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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. Receives: Drug: Triamcinolone Acetonide; Drug: Bupivacaine Hydrochloride |
| Group 2 | Active comparator | 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-intra-articular Injection.
Value of intra-articular Injection in Pain Reduction of chronic knee pain manifested by recurrence of pain.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start17 Sep 2024
- Primary completionJan 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElKashef, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641206
- Sponsor's protocol ID
- 36264PR843/9/24
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Dexmedetomidine for Treatment of Chronic Knee Pain: A Prospective Case-Control Clinical Trial
- ClinicalTrials.gov ID
- NCT06641206
- Acronym / sponsor ID
- 36264PR843/9/24
- Conditions
- Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Triamcinolone Acetonide, Drug: Bupivacaine HydrochlorideA 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. |
| Group 2 | Active comparator | Drug: DexmedetomidineA 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were not assigned for surgical intervention;
- Patients were free of exclusion criteria
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Acetonide1 ml of triamcinolone acetonide was used to prepare a solution for knee injection for patients with Chronic Knee Pain | Drug | Group 1 |
| Bupivacaine Hydrochloride20mg of bupivacaine hydrochloride was used to prepare a solution for knee injection for patients with Chronic Knee Pain | Drug | Group 1 |
| DexmedetomidineDexmedetomidine solution was prepared by mixing Dexmedetomidine in a dose of 3 µg/kg in 5-ml saline | Drug | Group 2 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone Acetonide, Bupivacaine Hydrochloride and Dexmedetomidine in people with Chronic Knee Pain, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-intra-articular Injection. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.