Trial | NCT01561209  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    212
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.
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.
Study Started
Mar 31
2012
Primary Completion
Jun 30
2014
Study Completion
Jun 30
2014
Last Update
Aug 29
2017

Drug Amitryptiline

Amitryptiline 5 mg before bedtime for 2 months

  • Other names: Tryptizol, Laroxyl

Drug Placebo

Placebo pill 1 before bedtime

  • Other names: No brand name

Amitryptiline Active Comparator

Amitryptiline 5 mg before bedtime

Placebo Placebo Comparator

Placebo pill

Criteria 

Inclusion Criteria:

Chronic neck pain (since more than 3 months, and more than 15 days/month)
Normal neurologic exam
X-ray = normal or loss of lordosis

Exclusion Criteria:

Neurologic signs or symptoms
Past history of neck surgery
MRI = abnormal findings except for loss of lordosis
Past cervical trauma
severe depression
drug abuse
pregnancy
Follow-up not possible
cardiac rhythms problems
Glaucoma
Urinary tract obstruction or prostatism
No Results Posted