Low Doses Amitriptyline & Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561209
• Other study ID #: AMIT-CNP
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2012
• Last updated: August 26, 2017
• Start date: March 2012
• Est. completion date: June 2014

Study information

• Verified date: August 2017
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

Drug:
• Amitryptiline
Amitryptiline 5 mg before bedtime for 2 months
• Placebo
Placebo pill 1 before bedtime

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de france Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual analog scale (VAS)	Pain assessment on VAS at 2 months compared to baseline	0 and 2 months after treatment
Secondary	Change in Bergen insomnia score	it assesses the sleep quality of the patient at 2 months compared to baseline	0, 2 months
Secondary	Change in Neck pain disability score	NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline	0, 2 months
Secondary	side effects	reporting the side effects by the patient	Up to 12 weeks after treatment
Secondary	Percentage of satisfaction	Pain subjective percentage of improvement	2 months after treatment
Secondary	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