Osteoarthritis of KneePhase 4NCT06837012
Duloxetine As an Analgesic in Patients Without Central Sensitivity After Same Sitting Bilateral Total Knee Arthroplasty
A Phase 4 study testing Duloxetine - low dose in people with Osteoarthritis of Knee and Central Sensitization, run by Orthopaedic Arthroscopy Knee and Shoulder Clinic at 1 site in India.
Trial summary
Analgesic effect of 20mg Duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Knee, Central Sensitization, Central Sensitisation
- What is being tested?
- Duloxetine - low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2021to 31 Jul 2022
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Bilateral tricompartmental knee osteoarthritis
- Underwent primary, bilateral TKA in single-sitting
Who cannot join
- American Society of Anesthesiologists physical status IV
- Hamilton Depression Scale (HAMD) and/or Hamilton Anxiety Scale (HAMA) scores > 7
- known intolerance or allergy to any of the study drugs, alcohol, tobacco, narcotic, or opioid dependence
- patients on anticoagulants
- known hepatic/renal dysfunction
- serious cardiac/cerebrovascular comorbidities
- HbA1c≥7
- patients who were already on duloxetine or other SNRIs, monoamine oxidase inhibitors, tricyclic antidepressants, triptans, lithium, other antiepileptics, or buspirone.
Trial locations and contacts
1 site in 1 country.
India1 site
Orthopaedic Arthroscopy Knee and shoulder clinic
Mumbai, Maharasthra, 400007
About this study
Official title: Duloxetine As an Analgesic in Patients Without Central Sensitivity Undergoing Single-sitting, Bilateral Total Knee Arthroplasty: a Prospective, Double-blinded, Randomised, Placebo-controlled Trial
Analgesic effect of 20mg Duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score.
Read the detailed description
Patients who underwent bilateral, single-sitting total knee arthroplasty for tricompartmental knee osteoarthritis were evaluated preoperatively for having central sensitivity. Only patients without central sensitisation were recruited and randomised into two groups with one group given 20 mg duloxetine capsules and the other group given a starch capsule of same shape, make, and weight as a placebo. Patients were evaluated for pain at rest and movement using VAS. A 6-hourly calculation of VAS was done over the first 48 hours and the average was recorded. Subsequent measurements at 1 week, 2 weeks, 4 weeks, and 3 months after surgery was done by a blinded clinician. Additional, drug safety, NSAID consumption and overall patient satisfaction were studied.
- Being tested
- Duloxetine - low dose, Placebo
- Keywords
- Duloxetine, Total knee arthroplasty, Analgesic, Central sensitisation, Pain, SNRI, Chronic
- Medical subject headings
- Osteoarthritis, Knee, Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine - low doseDrug
Only patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated
PlaceboDrug
starch capsules identical in appearance and weight to the duloxetine capsules
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine group | Active comparator | Patients given duloxetine Receives: Drug: Duloxetine - low dose |
| Placebo group | Placebo comparator | Patients given starch capsules identical in appearance and weight to the duloxetine capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting Visual Analogue Score for pain
The patient has to mark the degree of pain on a scale of 0 to 10 with 10 being the worst pain ever felt and 0 being no pain value were minimum 0 to maximum 10 Higher number denotes more pain and worse outcome
Measured: from enrolment to 3 months after surgery
Visual Analogue Score for pain on movement
The patient has to mark the degree of pain on a scale of 0 to 10 with 10 being the worst pain ever felt and 0 being no pain value were minimum 0 to maximum 10 Higher number denotes more pain and worse outcome
Measured: from enrolment to 3 months after surgery
Secondary outcomes (2)
NSAID consumption
calculated in milligrams of etoricoxib with higher number denoting worse outcome
Measured: from enrolment to 3 months after surgery
adverse effects
Measured: from enrolment to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jan 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Arthroscopy Knee and Shoulder Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- The Grant Medical College & Sir J.J. Group of Hospitals
- Responsible party
- Principal investigator, Dr. Amyn Rajani, The Grant Medical College & Sir J.J. Group of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837012
- Sponsor's protocol ID
- MDC/12/12/2020
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Can be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine As an Analgesic in Patients Without Central Sensitivity Undergoing Single-sitting, Bilateral Total Knee Arthroplasty: a Prospective, Double-blinded, Randomised, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06837012
- Acronym / sponsor ID
- MDC/12/12/2020
- Keywords
- Duloxetine, Total knee arthroplasty, Analgesic, Central sensitisation, Pain, SNRI, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Orthopaedic Arthroscopy Knee and Shoulder ClinicUniversity, hospital or other
- Collaborators
- The Grant Medical College & Sir J.J. Group of Hospitals
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 20 Feb 2025 (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.
Analgesic effect of 20mg Duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score.
Detailed description
Patients who underwent bilateral, single-sitting total knee arthroplasty for tricompartmental knee osteoarthritis were evaluated preoperatively for having central sensitivity. Only patients without central sensitisation were recruited and randomised into two groups with one group given 20 mg duloxetine capsules and the other group given a starch capsule of same shape, make, and weight as a placebo. Patients were evaluated for pain at rest and movement using VAS. A 6-hourly calculation of VAS was done over the first 48 hours and the average was recorded. Subsequent measurements at 1 week, 2 weeks, 4 weeks, and 3 months after surgery was done by a blinded clinician. Additional, drug safety, NSAID consumption and overall patient satisfaction were studied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine group | Active comparator | Drug: Duloxetine - low dosePatients given duloxetine |
| Placebo group | Placebo comparator | Drug: PlaceboPatients given starch capsules identical in appearance and weight to the duloxetine capsules |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral tricompartmental knee osteoarthritis
- Underwent primary, bilateral TKA in single-sitting
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists physical status IV
- Hamilton Depression Scale (HAMD) and/or Hamilton Anxiety Scale (HAMA) scores > 7
- known intolerance or allergy to any of the study drugs, alcohol, tobacco, narcotic, or opioid dependence
- patients on anticoagulants
- known hepatic/renal dysfunction
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 |
|---|---|---|
| Duloxetine - low doseOnly patients who underwent single bilateral Total knee arthroplasty and WITHOUT central sensitisation were evaluated | Drug | Duloxetine group |
| Placebostarch capsules identical in appearance and weight to the duloxetine capsules | Drug | Placebo group |
Primary outcome
resting Visual Analogue Score for pain
Time frame: from enrolment to 3 months after surgery
The patient has to mark the degree of pain on a scale of 0 to 10 with 10 being the worst pain ever felt and 0 being no pain value were minimum 0 to maximum 10 Higher number denotes more pain and worse outcome
Visual Analogue Score for pain on movement
Time frame: from enrolment to 3 months after surgery
The patient has to mark the degree of pain on a scale of 0 to 10 with 10 being the worst pain ever felt and 0 being no pain value were minimum 0 to maximum 10 Higher number denotes more pain and worse outcome
2 secondary outcomes
NSAID consumption
Time frame: from enrolment to 3 months after surgery
adverse effects
Time frame: from enrolment to 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No. Can be made available upon reasonable request
Related trials for Osteoarthritis of Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine - low dose in people with Osteoarthritis of Knee and Central Sensitization, run by Orthopaedic Arthroscopy Knee and Shoulder Clinic at 1 site in India.
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 8 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: finished, as of the sponsor's last update on 20 Feb 2025. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting Visual Analogue Score for pain (time frame: from enrolment to 3 months after surgery). The study lists 2 primary outcomes in all. 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 20 Feb 2025.