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Effect of DUOLXETINE in central post-stroke pain

EFFICACY OF DULOXETINE IN PATIENTS WITH CENTRAL POST-STROKE PAIN: A RANDOMISED DOUBLE BLIND PLACEBO CONTROLLED STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031875
Enrollment
82
Registered
2021-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G890- Central pain syndrome

Interventions

Intervention1: DULOXETINE: duloxetine 30mg in the night every day and followed up at 2weeks if no response, i.e, decrement in NRS score less than 2 then the dose is doubled and again followed up afte

Sponsors

INSTITUE OF MEDICAL SCIENCES BHU
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: �Aged 18 years or older �Positive history of hemorrhagic or ischemic stroke with lesion in the unilateral brain region proved by computed tomography or magnetic resonance imaging of the brain �Presence of signs and symptoms in accordance with a decrease in pain and heat sensations in the affected part of the body �Presence of spontaneous or stimulated pain in the affected side, which could be smaller or the same in size as the sensory impairment area, fulfilling the mandatory criteria proposed by Klit et al. �Patients with moderate to severe pain (Numeric Rating Scale (NRS) score of 4 and higher) are included. � Patients who are already on any other drugs for CPSP can be included in the study after providing a washout period of two weeks �Only first episode stroke patients to be taken in the study.

Exclusion criteria

Exclusion criteria: �Not willing to participate in the study �Lack of imaging findings compatible with stroke (like tumors) �Likely peripheral causes of pain (pain due to spasticity, nociceptive, psychogenic causes) �Hypersensitivity to duloxetine �Previous treatment with SNRIs �Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
change in pain intensity from baseline to 4weeks, as assessed by numeric rating scale(NRS), ranging from 0- no pain to 10- worst imaginable pain during the previous 24hoursTimepoint: baseline, 2weeks, 4weeks

Secondary

MeasureTime frame
Change in average pain severity as measured by short form Mc Gill pain questionnaire (SFMPQ) during the previous 24hours Timepoint: baseline, 2weeks, 4weeks;change in pain disability index (PDI)Timepoint: baseline, 2weeks, 4weeks;patient global impression of change(PGIC)Timepoint: 4 weeks

Countries

India

Contacts

Public ContactDr BANDARI MAHESH

INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY

goforrameshwar@gmail.com9415353255

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026