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Low Doses Amitriptyline & Chronic Neck Pain

Information source: St Joseph University, Beirut, Lebanon
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neck Pain

Intervention: Amitryptiline (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: St Joseph University, Beirut, Lebanon

Official(s) and/or principal investigator(s):
Joseph Maarrawi, MD, PhD, Principal Investigator, Affiliation: St Joseph University, Beirut, Lebanon

Overall contact:
Joseph Maarrawi, MD, PhD, Phone: 01615300, Ext: 9512, Email: joseph.maarrawi@usj.edu.lb

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Visual analog scale (VAS)

Secondary outcome:

Bergen insomnia score

Neck pain disability score

Neck pain diary

side effects

Visual analog scale (VAS)

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 1, 2 and 3 months and outcome measures are assessed.

Eligibility

Minimum age: 20 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Joseph Maarrawi, MD, PhD, Phone: 01615300, Ext: 9512, Email: joseph.maarrawi@usj.edu.lb

Hotel Dieu de france Hospital, Beirut 16 6830, Lebanon; Recruiting
Joseph Maarrawi, MD, PhD, Phone: 01615300, Ext: 9512, Email: joseph.maarrawi@usj.edu.lb
Additional Information

Starting date: March 2012
Last updated: December 16, 2012

Page last updated: February 07, 2013

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