Low Doses Amitriptyline & Chronic Neck Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Amitryptiline

Amitryptiline 5 mg before bedtime

Group Type ACTIVE_COMPARATOR

Amitryptiline

Intervention Type DRUG

Amitryptiline 5 mg before bedtime for 2 months

Placebo

Placebo pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill

1 before bedtime

Interventions

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Amitryptiline

Amitryptiline 5 mg before bedtime for 2 months

Intervention Type DRUG

Placebo

Placebo pill

1 before bedtime

Intervention Type DRUG

Other Intervention Names

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Tryptizol Laroxyl No brand name

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No