Low Doses Amitriptyline & Chronic Neck Pain

Phase 4

Completed

• Conditions: Neck Pain
• Interventions: Drug: Amitryptiline; Drug: Placebo

• Registration Number: NCT01561209
• Lead Sponsor: St Joseph University, Beirut, Lebanon

Brief 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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-14
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-26
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amitryptiline	Amitryptiline	Amitryptiline 5 mg before bedtime
Placebo	Placebo	Placebo pill

Primary Outcome Measures

Name	Time	Method
Change in Visual analog scale (VAS)	0 and 2 months after treatment	Pain assessment on VAS at 2 months compared to baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hotel Dieu de france Hospital; 🇱🇧 Beirut, Lebanon