NCT01561209

Low Doses Amitriptyline & Chronic Neck Pain

Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: St Joseph University, Beirut, Lebanon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective randomized and controlled study is to evaluate the efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.

Detailed description

Patients with chronic neck pain, lasting since at least 3 months, are recruited from our pain clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1-Amitriptyline 5 mg for 2 months 2- placebo for 2 months. Co-morbidities and other painful conditions are noted, and then clinical evaluation of the patient is performed; pain is assessed according to Visual Analog Scale, anxiety, depression, insomnia and disability are evaluated by adapted scores (Bergen insomnia scale, neck pain disability score, neck pain diary \& anxiety and depression score). Patients are followed at 2 months and outcome measures are assessed.

Conditions

• Neck Pain

Interventions

Type	Name	Description
DRUG	Amitryptiline	Amitryptiline 5 mg before bedtime for 2 months
DRUG	Placebo	Placebo pill 1 before bedtime

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-03-22
• Last updated: 2017-08-29

Locations

1 site across 1 country: Lebanon