Low Doses Amitriptyline & Chronic Neck Pain

St Joseph University, Beirut, Lebanon

Status and phase: Completed; Phase 4

Conditions: Neck Pain

Treatments: Drug: Amitryptiline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01561209

AMIT-CNP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 212 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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212 participants in 2 patient groups, including a placebo group

Amitryptiline

Active Comparator group

Description:

Amitryptiline 5 mg before bedtime

Treatment:

Drug: Amitryptiline

Placebo

Placebo Comparator group

Description:

Placebo pill

Treatment:

Drug: Placebo