NCT02223442

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 22, 2014

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

August 20, 2014

Last Update Submit

August 20, 2014

Conditions

Keywords

chronic paincentral analgesic drugsadherence to therapyside effectsquality of lifeMOR-NRI drugs

Outcome Measures

Primary Outcomes (1)

  • adherence to therapy

    to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment

    18 months

Secondary Outcomes (3)

  • adherence at 6 months

    18 months

  • side effects

    18 months

  • quality of life

    18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with persistent pain syndromes (chronic pain) followed on an outpatient / DH at some Italian centers of Pain Therapy

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Compagnone

    University of Parma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 22, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2017

Last Updated

August 22, 2014

Record last verified: 2012-11