Neck PainPhase 4NCT01561209
Low Doses Amitriptyline & Chronic Neck Pain
A Phase 4 study testing Amitryptiline in people with Neck Pain, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Amitryptiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteLebanon
- Study dates
- Mar 2012to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic neck pain (since more than 3 months, and more than 15 days/month)
- Normal neurologic exam
- X-ray = normal or loss of lordosis
Who cannot join
- Neurologic signs or symptoms
- Past history of neck surgery
- MRI = abnormal findings except for loss of lordosis
- Past cervical trauma
- severe depression
- drug abuse
Show all 11Show fewer
- pregnancy
- Follow-up not possible
- cardiac rhythms problems
- Glaucoma
- Urinary tract obstruction or prostatism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of 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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Amitryptiline, Placebo
- Keywords
- amitryptiline, Chronic pain, Neck pain
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitryptilineDrug
Also called Tryptizol, Laroxyl
Amitryptiline 5 mg before bedtime for 2 months
PlaceboDrug
Also called No brand name
Placebo pill
1 before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Amitryptiline | Active comparator | Amitryptiline 5 mg before bedtime Receives: Drug: Amitryptiline |
| Placebo | Placebo comparator | Placebo pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual analog scale (VAS)
Pain assessment on VAS at 2 months compared to baseline
Measured: 0 and 2 months after treatment
Secondary outcomes (5)
Change in Bergen insomnia score
it assesses the sleep quality of the patient at 2 months compared to baseline
Measured: 0, 2 months
Change in Neck pain disability score
NECK PAIN DISABILITY INDEX QUESTIONNAIRE at 2 months compared to baseline
Measured: 0, 2 months
side effects
reporting the side effects by the patient
Measured: Up to 12 weeks after treatment
Percentage of satisfaction
Pain subjective percentage of improvement
Measured: 2 months after treatment
Change in Hospital Anxiety and Depression Scale (HADS)
Assessment of anxiety and depressive symptoms at 2 months compared to baseline
Measured: 0 and 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Joseph University, Beirut, Lebanon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Joseph Maarrawi, St Joseph University, Beirut, Lebanon
- Investigators
- Joseph Maarrawi, MD, PhD, Principal investigator, St Joseph University, Beirut, Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561209
- Sponsor's protocol ID
- AMIT-CNP
- Status last verified
- Aug 2017
- First submitted
- 14 Mar 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized & Controlled Study of the Role of Low Doses Amitriptyline in the Management of Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01561209
- Acronym / sponsor ID
- AMIT-CNP
- Conditions
- Neck Pain
- Keywords
- amitryptiline, Chronic pain, Neck pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- St Joseph University, Beirut, LebanonUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amitryptiline | Active comparator | Drug: AmitryptilineAmitryptiline 5 mg before bedtime |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic neck pain (since more than 3 months, and more than 15 days/month)
- Normal neurologic exam
- X-ray = normal or loss of lordosis
Key exclusion criteria (11 listed)
- Neurologic signs or symptoms
- Past history of neck surgery
- MRI = abnormal findings except for loss of lordosis
- Past cervical trauma
- severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmitryptilineAlso: Tryptizol, LaroxylAmitryptiline 5 mg before bedtime for 2 months | Drug | Amitryptiline |
| PlaceboAlso: No brand namePlacebo pill 1 before bedtime | Drug | Placebo |
Primary outcome
Change in Visual analog scale (VAS)
Time frame: 0 and 2 months after treatment
Pain assessment on VAS at 2 months compared to baseline
5 secondary outcomes
Change in Bergen insomnia score
Time frame: 0, 2 months
Change in Neck pain disability score
Time frame: 0, 2 months
side effects
Time frame: Up to 12 weeks after treatment
Percentage of satisfaction
Time frame: 2 months after treatment
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: 0 and 2 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Maarrawi, MD, PhD principal investigator
St Joseph University, Beirut, Lebanon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amitryptiline in people with Neck Pain, run by St Joseph University, Beirut, Lebanon at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual analog scale (VAS) (time frame: 0 and 2 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.