Low Doses Amitriptyline & Chronic Neck Pain
Information source: St Joseph University, Beirut, Lebanon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neck Pain
Intervention: Amitryptiline (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
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
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 scoreNeck 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
Hotel Dieu de france Hospital, Beirut 16 6830, Lebanon
Additional Information
Starting date: March 2012
Last updated: June 9, 2014
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