Clinical trial NCT02223442: Central Analgesic Drugs for the Treatment of Chronic Pain
Official title: Cognitive Study on the Use of Central Analgesic Drugs in the Management of Chronic Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: chronic pain
central analgesic drugs
adherence to therapy
side effects
quality of life
MOR-NRI drugs
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with persistent pain syndromes (chronic pain) followed on an outpatient / DH at some Italian centers of Pain Therapy

Brief 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".

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: adherence to therapy
timeFrame: 18 months
Secondary outcomes:
measure: adherence at 6 months
timeFrame: 18 months
measure: side effects
timeFrame: 18 months
measure: quality of life
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Parma
name: Christian Compagnone
role: PRINCIPAL_INVESTIGATOR
References: