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A comparison of analgesic efficacy between Amitriptyline and Mianserin in chronic low back pain patients: A randomized double-blind controlled trial

A comparison of analgesic efficacy between Amitriptyline and Mianserin in chronic low back pain patients: A randomized double-blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190303001
Enrollment
60
Registered
2019-03-03
Start date
2019-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Chronic low back pain low back pain tricyclic antidepressant mianserin amitriptyline

Interventions

incremental amitriptyline dosage form 10 mg/day to 50 mg/day,incremental mianserin dosage form 10 mg/day to 50 mg/day
Active Comparator Drug,Active Comparator Drug
Amitriptyline,Mianserin

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18 - 65 years old 2. Chronic low back pain for more than 3 months with Numerical rating scale; NRS > 4 3. Able to read and write 4. Without any cancer

Exclusion criteria

Exclusion criteria: 1. Allergy to Amitriptyline and/or Mianserin 2. Psychiatric problem 3. Pregnancy 4. Benign prostatic hyperplasia, glaucoma, high intra-ocular pressure, arrhythmia 5. Planning for pain intervention

Design outcomes

Primary

MeasureTime frame
Pain score 1, 2, 3, 5, 6 ,9 ,12 week Numeric rating scale

Secondary

MeasureTime frame
Function Disabilities 1, 2, 3, 5, 6 ,9 ,12 week Oswestry version 1.0,Mental status 1, 2, 3, 5, 6 ,9 ,12 week DASS 21,Quality of life 1, 2, 3, 5, 6 ,9 ,12 week EQ-5D-5L

Countries

Thailand

Contacts

Public ContactSuratsawadee Wangnamthip

Department of Anesthesiology, Siriraj Hospital

suratsawadee.wang@gmail.com0819261509

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026