Effect of Milnacipran / Gabapentin in Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Registration Number
- NCT05384210
- Lead Sponsor
- Mansoura University
- Brief Summary
Gabapentin and milnacipran (MLN) show strong evidence of reduced pain, increased sleep, and improvement in the quality of life in fibromyalgia (FM) patients.
Most FM trials focus primarily on pain reduction with monotherapy. Polypharmacy is commonly used, but supportive evidence is limited.
The gabapentin-MLN combined therapy may be more effective in female patients with FM than their monotherapy.
- Detailed Description
The aim of the study is to evaluate the analgesic efficacy of gabapentin-MLN as combined or monotherapy on patients with FM.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 75
- There are no other criteria rather than age and sex
- Patient refusal.
- Pregnancy or breastfeeding.
- Active liver disease
- Renal impairment (creatinine clearance < 60 mL/min).
- Documented autoimmune disease.
- Severe chronic obstructive pulmonary disease.
- Recent arrhythmia
- Myocardial infarction
- Stroke.
- Uncontrolled hypertension.
- Glaucoma.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined gabapentin/milnacipran Combined gabapentin/milnacipran Patients will receive combined gabapentin and milnacipran as a combination therapy will be administered in increment doses for 3 months Milnacipran Milnacipran Patients will receive Milnacipran as a mono-therapy will be administered in increment doses for 3 months Gabapentin Gabapentin patients will receive Gabapentin as a mono-therapy will be administered in increment doses for 3 months
- Primary Outcome Measures
Name Time Method Visual analogue scale (VAS) for pain 3 months Assesses the overall pain of fibromyalgia on a 10 cm pain scale with 0 indicating no pain and 10 indicating the worst pain ever
- Secondary Outcome Measures
Name Time Method The Fibromyalgia Impact Questionnaire (FIQ). 3 months Assesses the overall functional ability and the impact of fibromyalgia on the patient's life, with a range from 0-100, 0 indicating no functional impairment or effect of the disease on the patient's life and 100 indicating a very bad and tremendous effect of fibromyalgia on the patient's life.
Leeds Sleep Evaluation Questionnaire 3 months The four aspects of sleep around which the questionnaire is devised (Getting to sleep, GTS; Quality of sleep, QOS; Awakening from sleep, AFS; Behaviour following wakefulness, BFW), and assessing the effect of medication on the quality of sleep each question is a 100 mm line that the patient marks, 0 meaning very bad effect or worsening in sleep pattern, 50 meaning no improvement what so ever with no deterioration and 100 meaning excellent improvement in the sleep pattern
Trial Locations
- Locations (1)
Mansoura University
🇪🇬Mansoura, DK, Egypt