Low Doses Amitriptyline & Chronic Neck Pain

S

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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