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Knee OsteoarthritisPhase 4NCT04532684

Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain

A Phase 4 study testing Duloxetine and Pregabalin in people with Knee Osteoarthritis, run by Fatih Sultan Mehmet Training and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at older age.It is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. Read more about this study

Who is it for?
Ages 40 to 69 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Duloxetine and Pregabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
Oct 2016to 15 Dec 2020
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 40 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 40-69
  • Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria
  • Grade 2-3 knee osteoarthritis according to Kellgren-Lawrence grading system
  • VAS-pain score: 4 and above
  • Neuropathic Pain Diagnostic Questionnaire (DN4) score: 4 and above
  • Body mass index value: 40 and below

Who cannot join

  • A history of trauma or surgical operation in the knee region
  • Diabetes mellitus
  • Fibromyalgia
  • Inflammatory rheumatic disease
  • Central or peripheral neurological disorder
  • Severe cardiac, pulmonary, or malignant disease
  • Invasive treatment for knee last 3 months

About this study

Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at older age.It is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. Addition of molecules targeting neuropathic pain to conventional therapy has been shown to improve treatment response in the management of osteoarthritis.The aim of our study is to evaluate the effect of duloxetine and pregabalin on pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee osteoarthritis.

Read the detailed description

A total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. The patients were evaluated before and one month after treatment and three months after treatment using the visual analog scale (VAS-pain), Neuropathic Pain Diagnostic Questionnaire (DN4), Short Form-36 (SF-36) Questionnaire, Western Ontario and McMaster University Osteoarthritis İndeks (WOMAC), Beck Depression Scale (BDS), Beck Anxiety Akalası (BAS), Pittsburg Sleep Quality Index (PSQI).

Being tested
Duloxetine, Pregabalin
Keywords
Knee osteoartrhritis, Duloxetine, Pregabalin, Pain
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04532684
Study groupRoleWhat they receive
DuloxetineActive comparator33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks
Receives: Drug: Duloxetine
PregabalinActive comparator33 patients received 300 mg/day of pregabalin orally for 12 weeks
Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessing Visual Analog Scale Score Change in Patients

    All patients were asked to score the severity of their current knee pain on a 10-cm visual analogue scale (VAS).

    Measured: 0.,4., and 12. weeks

  2. Neuropthic Pain Diagnostic Questionnaire (DN4)

    There are 10 questions in the DN-4 including 7 questions related to pain quality and 3 questions that investigate the presence of tactile sensation, pinprick sensation, and allodynia. A total score 4/10 indicates neuropathic pain.

    Measured: 0.,4, and 12. weeks

  3. Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients

    The WOMAC consists of 24 questions that assess pain, stiffness, and problems with physical activities. The patient answers all questions on a 5-point Likert-type scale, and the total score ranges from 0 and 96.

    Measured: 0., 4. and 12. weeks

Secondary outcomes (4)

  1. Assessing Beck Depression Inventory Score Change in Patients

    Symptoms of depression were evaluated by means of the Beck Depression Inventory

    Measured: 0., 4. and 12. weeks

  2. Assesing Beck Anxiety Inventory Score Change in Patients

    Current anxiete state of patients was assessed by means of the Beck Anxiety Inventory

    Measured: 0.,4.,and 12. weeks

  3. Assessing Pittsburgh Sleep Quality Index Score Change in Patients

    Sleep quality assessments were performed by means of the Pittsburgh Sleep Quality Index

    Measured: 0.,4.,and 12. weeks

  4. Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients

    The SF-36 has eight subscales and consists of a total of 36 questions. The subscales are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. A score of 0 is equivalent to maximum disability (poor quality of life), and a score of 100 is equivalent to no disability (good quality of life).

    Measured: 0.,4.,and 12. weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study startOct 2016
  3. Primary completion15 Jul 2020
  4. Study completion15 Dec 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized prospective clinical trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04532684
Sponsor's protocol ID
ozgeilleez
Status last verified
May 2020
First submitted
23 Aug 2020
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Leaney AA, Lyttle JR, Segan J, Urquhart DM, Cicuttini FM, Chou L, Wluka AE. Antidepressants for hip and knee osteoarthritis. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012157. doi: 10.1002/14651858.CD012157.pub2.

    PubMed 36269595

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine and Pregabalin in people with Knee Osteoarthritis, run by Fatih Sultan Mehmet Training and Research Hospital.

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 6 inclusion and 7 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

Assessing Visual Analog Scale Score Change in Patients (time frame: 0.,4., and 12. weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04532684, which also lists 1 linked publication.

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 25 Jan 2021.

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