Chronic PainNCT02223442
Central Analgesic Drugs for the Treatment of Chronic Pain
An observational study of Chronic Pain, run by University of Parma.
Trial summary
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Feb 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with persistent pain syndromes (chronic pain) followed on an outpatient / DH at some Italian centers of Pain Therapy
Who may be able to join
- Males and females over the age of 18 years
- Chronic neuropathic and / or nociceptive and / or mixed pain, whereby clinicians considers necessary to start opioid therapy
- Signed informed consent
Who cannot join
- Males and females aged under 18 years
- Patients already receiving opioid analgesic drugs or drugs of the class MOR-NRI.
- Taking abuse drugs or alcohol abuse
- Patients with contraindications to the use of central analgesic drugs
- Patients who refuse participation
- Prior cognitive impairment or mental retardation
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- Severe immunodeficiency (WBC <4,000)
- Severe renal impairment (serum creatinine > 2g/dl or Creatinine clearance <30 ml / h)
- Hepatic impairment (Cholinesterase <2.000UI or INR> 2)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cognitive Study on the Use of Central Analgesic Drugs in the Management of Chronic Pain
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain .
However, pain management is mostly inadequate. This study aims to assess the Italian clinical practice in reference to the pharmacological management of chronic pain by health professionals involved in the treatment of pain in some centers belonging to the Italian network of pain therapy.
Read the detailed description
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
In fact, the Ministry of Health, first in Europe, introduced a law in 2010 (March 15, 2010, No. 38) to provide for the sick, cancer or not, easy access to the necessary care and to provide specialists a specific training course.
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain (Marcus 2011).
The "pain disease" is one of the most common causes of access to medical care so it should be recognized as a complex health and research problem, being one of the most expensive and investigated conditions in our society (Pizzo and Clark, 2012; Gupta et al. , 2010; Dagenais et al., 2008).
It has a significant impact on the subjective perception of health status, influence daily activities and is associated with symptoms of depression and other psychological problems that affect the quality of life of the patient (end of 2011 Gureje et al., 1998; Bair et al., 2003, Portenoy, 1996).
However, pain management is mostly inadequate for several medical and social reasons: difficulty in defining the complexity of its pathophysiology, difficulty in finding animal models useful for the development of analgesic drugs, difficulty in finding clinical models predictive of drug efficacy / security, lack of recognition of pain as a health issue and not adequate academic training.
A recent survey in Europe uncovered alarming data: 40% of surveyed patients (46,394) reported an inadequate treatment of accused pain (Breivik et al., 2006).
There are also several open questions regarding the research on the most powerful analgesic drugs used: opioids (Galer et al 1992).
There is no specific experimental model able to solve the three most pressing problems: the predictability of the patient's response, efficacy and safety of opioids.
There is no scientific evidence for the efficacy / safety of long-term use of opioids in chronic pain (Chapman et al., 2010; Manchikanti et al., 2011).
A recent review showed that approximately 22% of patients, suffering from chronic pain and on opioid therapy, suspends therapy for the occurrence of side effects and 5-10% of patients suspend it for a not proper control of pain symptoms (Noble et al., 2010).
This study aims to assess the Italian clinical practice in reference to the pharmacological management of chronic pain by health professionals involved in the treatment of pain in some centers belonging to the Italian network of pain therapy.
- Conditions
- Chronic Pain
- Keywords
- chronic pain, central analgesic drugs, adherence to therapy, side effects, quality of life, MOR-NRI drugs
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to therapy
to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment
Measured: 18 months
Secondary outcomes (3)
adherence at 6 months
differences between the central analgesic drugs in the percentage of patients who continue therapy (adherence) at 1 month and 6 months
Measured: 18 months
side effects
difference between the central analgesic drugs in the percentage of patients who develop side effects
Measured: 18 months
quality of life
difference between the central analgesic drugs with regard to the improvement of quality of life reported by the patient
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Compagnone, University of Parma
- Investigators
- Christian Compagnone, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223442
- Sponsor's protocol ID
- opioids for chronic pain
- Status last verified
- Nov 2012
- First submitted
- 20 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Study on the Use of Central Analgesic Drugs in the Management of Chronic Pain
- ClinicalTrials.gov ID
- NCT02223442
- Acronym / sponsor ID
- opioids for chronic pain
- Conditions
- Chronic Pain
- Keywords
- chronic pain, central analgesic drugs, adherence to therapy, side effects, quality of life, MOR-NRI drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 22 Aug 2014 (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.
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain .
However, pain management is mostly inadequate. This study aims to assess the Italian clinical practice in reference to the pharmacological management of chronic pain by health professionals involved in the treatment of pain in some centers belonging to the Italian network of pain therapy.
Detailed description
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
In fact, the Ministry of Health, first in Europe, introduced a law in 2010 (March 15, 2010, No. 38) to provide for the sick, cancer or not, easy access to the necessary care and to provide specialists a specific training course.
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain (Marcus 2011).
The "pain disease" is one of the most common causes of access to medical care so it should be recognized as a complex health and research problem, being one of the most expensive and investigated conditions in our society (Pizzo and Clark, 2012; Gupta et al. , 2010; Dagenais et al., 2008).
It has a significant impact on the subjective perception of health status, influence daily activities and is associated with symptoms of depression and other psychological problems that affect the quality of life of the patient (end of 2011 Gureje et al., 1998; Bair et al., 2003, Portenoy, 1996).
However, pain management is mostly inadequate for several medical and social reasons: difficulty in defining the complexity of its pathophysiology, difficulty in finding animal models useful for the development of analgesic drugs, difficulty in finding clinical models predictive of drug efficacy / security, lack of recognition of pain as a health issue and not adequate academic training.
A recent survey in Europe uncovered alarming data: 40% of surveyed patients (46,394) reported an inadequate treatment of accused pain (Breivik et al., 2006).
There are also several open questions regarding the research on the most powerful analgesic drugs used: opioids (Galer et al 1992).
There is no specific experimental model able to solve the three most pressing problems: the predictability of the patient's response, efficacy and safety of opioids.
There is no scientific evidence for the efficacy / safety of long-term use of opioids in chronic pain (Chapman et al., 2010; Manchikanti et al., 2011).
A recent review showed that approximately 22% of patients, suffering from chronic pain and on opioid therapy, suspends therapy for the occurrence of side effects and 5-10% of patients suspend it for a not proper control of pain symptoms (Noble et al., 2010).
This study aims to assess the Italian clinical practice in reference to the pharmacological management of chronic pain by health professionals involved in the treatment of pain in some centers belonging to the Italian network of pain therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with persistent pain syndromes (chronic pain) followed on an outpatient / DH at some Italian centers of Pain Therapy
Key inclusion criteria (3 listed)
- Males and females over the age of 18 years
- Chronic neuropathic and / or nociceptive and / or mixed pain, whereby clinicians considers necessary to start opioid therapy
- Signed informed consent
Key exclusion criteria (9 listed)
- Males and females aged under 18 years
- Patients already receiving opioid analgesic drugs or drugs of the class MOR-NRI.
- Taking abuse drugs or alcohol abuse
- Patients with contraindications to the use of central analgesic drugs
- Patients who refuse participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adherence to therapy
Time frame: 18 months
to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment
3 secondary outcomes
adherence at 6 months
Time frame: 18 months
side effects
Time frame: 18 months
quality of life
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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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.
Christian Compagnone principal investigator
University of Parma
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by University of Parma.
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 9 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: status not confirmed, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Compagnone (0521-703567, ccompagnone@parmanesthesia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adherence to therapy (time frame: 18 months). 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 22 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.