Low Doses Amitriptyline & Chronic Neck Pain

Last updated: August 26, 2017
Sponsor: St Joseph University, Beirut, Lebanon
Overall Status: Completed

Phase

4

Condition

Neck Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT01561209
AMIT-CNP
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 212
Study Start date:
March 01, 2012
Estimated Completion Date:
June 30, 2014

Study 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.

Connect with a study center

  • Hotel Dieu de france Hospital

    Beirut, 16 6830
    Lebanon

    Site Not Available

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