Low Doses Amitriptyline & Chronic Neck Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Drug: Amitryptiline; Drug: Placebo

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 2 months and outcome measures are assessed.

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon, 16 6830
    • Hotel Dieu de France Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amitryptiline; Amitryptiline 5 mg before bedtime	Drug: Amitryptiline; Amitryptiline 5 mg before bedtime for 2 months; Other Names: Tryptizol; Laroxyl
Placebo Comparator: Placebo; Placebo pill	Drug: Placebo; Placebo pill 1 before bedtime; Other Names: No brand name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual analog scale (VAS)	Pain assessment on VAS at 2 months compared to baseline	0 and 2 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Bergen insomnia score	it assesses the sleep quality of the patient at 2 months compared to baseline	0, 2 months
Change in Neck pain disability score	NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline	0, 2 months
side effects	reporting the side effects by the patient	Up to 12 weeks after treatment
Percentage of satisfaction	Pain subjective percentage of improvement	2 months after treatment
Change in Hospital Anxiety and Depression Scale (HADS)	Assessment of anxiety and depressive symptoms at 2 months compared to baseline	0 and 2 months after treatment

Collaborators and Investigators

• Sponsor: St Joseph University, Beirut, Lebanon
• Investigators: Principal Investigator: Joseph Maarrawi, MD, PhD, St Joseph University, Beirut, Lebanon

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 26, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Chronic pain; Neck pain; amitryptiline
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Amitriptyline
• Other Study ID Numbers: AMIT-CNP