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Completed

NCT Number: NCT01561209

Low Doses Amitriptyline & 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.

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Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu de france Hospital

Beirut, 16 6830, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amitryptiline

Drug

Amitryptiline 5 mg before bedtime for 2 months

Other names: Tryptizol, Laroxyl

Placebo

Drug

Placebo pill

1 before bedtime

Other names: No brand name

Primary outcomes

  1. Change in Visual analog scale (VAS)

    Time frame: 0 and 2 months after treatment

    Pain assessment on VAS at 2 months compared to baseline

Secondary outcomes

  1. Change in Bergen insomnia score

    Time frame: 0, 2 months

    it assesses the sleep quality of the patient at 2 months compared to baseline

  2. Change in Neck pain disability score

    Time frame: 0, 2 months

    NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline

  3. side effects

    Time frame: Up to 12 weeks after treatment

    reporting the side effects by the patient

  4. Percentage of satisfaction

    Time frame: 2 months after treatment

    Pain subjective percentage of improvement

  5. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: 0 and 2 months after treatment

    Assessment of anxiety and depressive symptoms at 2 months compared to baseline

Sponsors and collaborators

Lead sponsor

St Joseph University, Beirut, Lebanon

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2012
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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