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Low Doses Amitriptyline & Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Amitryptiline
Placebo
Sponsored by
St Joseph University, Beirut, Lebanon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring amitryptiline, Chronic pain, Neck pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hotel Dieu de france Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Amitryptiline

Placebo

Arm Description

Amitryptiline 5 mg before bedtime

Placebo pill

Outcomes

Primary Outcome Measures

Change in Visual analog scale (VAS)
Pain assessment on VAS at 2 months compared to baseline

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2012
Last Updated
August 26, 2017
Sponsor
St Joseph University, Beirut, Lebanon
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1. Study Identification

Unique Protocol Identification Number
NCT01561209
Brief Title
Low Doses Amitriptyline & Chronic Neck Pain
Official Title
Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Joseph University, Beirut, Lebanon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
amitryptiline, Chronic pain, Neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
212 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amitryptiline
Arm Type
Active Comparator
Arm Description
Amitryptiline 5 mg before bedtime
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill
Intervention Type
Drug
Intervention Name(s)
Amitryptiline
Other Intervention Name(s)
Tryptizol, Laroxyl
Intervention Description
Amitryptiline 5 mg before bedtime for 2 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
No brand name
Intervention Description
Placebo pill 1 before bedtime
Primary Outcome Measure Information:
Title
Change in Visual analog scale (VAS)
Description
Pain assessment on VAS at 2 months compared to baseline
Time Frame
0 and 2 months after treatment
Secondary Outcome Measure Information:
Title
Change in Bergen insomnia score
Description
it assesses the sleep quality of the patient at 2 months compared to baseline
Time Frame
0, 2 months
Title
Change in Neck pain disability score
Description
NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline
Time Frame
0, 2 months
Title
side effects
Description
reporting the side effects by the patient
Time Frame
Up to 12 weeks after treatment
Title
Percentage of satisfaction
Description
Pain subjective percentage of improvement
Time Frame
2 months after treatment
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
Assessment of anxiety and depressive symptoms at 2 months compared to baseline
Time Frame
0 and 2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Maarrawi, MD, PhD
Organizational Affiliation
St Joseph University, Beirut, Lebanon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu de france Hospital
City
Beirut
ZIP/Postal Code
16 6830
Country
Lebanon

12. IPD Sharing Statement

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Low Doses Amitriptyline & Chronic Neck Pain

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