Clinical trial NCT04532684: Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain
Official title: Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Knee osteoartrhritis
Duloxetine
Pregabalin
Pain
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective clinical trial
Primary purpose: TREATMENT

Brief 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. 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessing Visual Analog Scale Score Change in Patients
timeFrame: 0.,4., and 12. weeks
measure: Neuropthic Pain Diagnostic Questionnaire (DN4)
timeFrame: 0.,4, and 12. weeks
measure: Assessing Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score Change in Patients
timeFrame: 0., 4. and 12. weeks
Secondary outcomes:
measure: Assessing Beck Depression Inventory Score Change in Patients
timeFrame: 0., 4. and 12. weeks
measure: Assesing Beck Anxiety Inventory Score Change in Patients
timeFrame: 0.,4.,and 12. weeks
measure: Assessing Pittsburgh Sleep Quality Index Score Change in Patients
timeFrame: 0.,4.,and 12. weeks
measure: Assessing Short Form-36 (SF-36) Questionnaire Score Change in Patients
timeFrame: 0.,4.,and 12. weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Özge Gülsüm İlleez, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.