Effects of Duloxetine and Clonazepam on sleep quality and pain in low back pain of long duration

Comparison of Duloxetine and Clonazepam on quality of sleep and pain in chronic low back pain - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076390

Enrollment

Registered

2024-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: M545- Low back pain

Interventions

Intervention1: DULOXETINE: Duloxetine 20mg (may be titrated upto 60mg) per Day P.O. upto 12 weeks Control Intervention1: CLONAZEPAM: Clonazepam 0.5 mg per Day P.O. upto 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Clinically Diagnosed case of Non- Specific Low Back Pain

Exclusion criteria

Exclusion criteria: 1. Patients already having Sleep disturbances even before onset of Low Back Pain. 2. Patients with known underlying psychological disorder or on any Psychotropic Medication. 3. Pregnant and Breastfeeding Females. 4. Patients having contraindications to Benzodiazepines and SNRIs. 5. Patient’s Refusal.

Design outcomes

Primary

Measure	Time frame
To assess and compare the improvement in Pittsburgh Sleep Quality Index (PSQI) between two groupsTimepoint: Data will be collected on 6th week and 12th week post intervention	—

Secondary

Measure	Time frame
To assess and compare the improvement in pain as per NPRS Scale between two groupsTimepoint: Data will be collected on 6th week and 12th week post intervention	—

Countries

India

Contacts

Public ContactAnkit Sarkar

R G Kar Medical College and Hospital, Kolkata

rehabyouall@gmail.com9433915696

Outcome results

None listed

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