Low Doses Amitriptyline & Chronic Neck Pain

St Joseph University, Beirut, Lebanon212 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

212

Conditions

Neck Pain

Interventions

AmitryptilineDRUG

Amitryptiline 5 mg before bedtime for 2 months

PlaceboDRUG

Placebo pill 1 before bedtime

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (1)

Hotel Dieu de france Hospital

Beirut, Lebanon

Outcomes

Primary Outcomes

Change in Visual analog scale (VAS)

Pain assessment on VAS at 2 months compared to baseline

Time frame: 0 and 2 months after treatment

Secondary Outcomes

Change in Bergen insomnia score

it assesses the sleep quality of the patient at 2 months compared to baseline

Time frame: 0, 2 months

Change in Neck pain disability score

NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline

Time frame: 0, 2 months

side effects

reporting the side effects by the patient

Time frame: Up to 12 weeks after treatment

Percentage of satisfaction

Pain subjective percentage of improvement

Time frame: 2 months after treatment

Change in Hospital Anxiety and Depression Scale (HADS)

Assessment of anxiety and depressive symptoms at 2 months compared to baseline

Time frame: 0 and 2 months after treatment

Data from ClinicalTrials.gov

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