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Chronic PainNCT02223442

Central Analgesic Drugs for the Treatment of Chronic Pain

An observational study of Chronic Pain, run by University of Parma.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Show all 9Show fewer
  • 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.

Christian Compagnone contact

0521-703567

ccompagnone@parmanesthesia.com

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.

  1. 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)
  1. 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

  2. side effects

    difference between the central analgesic drugs in the percentage of patients who develop side effects

    Measured: 18 months

  3. 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.

  1. First posted22 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2016 (estimated)
  4. Study completionFeb 2017 (estimated)

Resources

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)
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

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.

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