Observational Study Aimed at Evaluating the Trend of Neuropathic Pain

NCT06324123 | Completed

• 1 other identifier: 23C304
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 3

Brief Summary

The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months. Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.

Conditions

Neuropathic Pain

Keywords

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in neuropathic pain after two months of treatment with Peacetil

  Assessed by the Numerical Rating Scale (NRS) score

  At enrollment and at two months after the start of treatment with Peacetil

Secondary Outcomes (1)

• Change in neuropathic pain after one month of treatment with Peacetil

  At enrollment and at one month after the start of treatment with Peacetil

Study Arms (1)

Patients with neuropathic pain

Patients with acute or chronic neuropathic pain

Other: Peacetil

Interventions

Peacetil OTHER

Nutraceutical supplement Peacetil for a period of 2 months

Patients with neuropathic pain

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Monitoring of the reduction of neuropathic pain after 1 month and after 2 months of treatment with the nutraceutical PEACETIL, introduced according to clinical practice, and 1 month after the end of treatment. Evaluation of the pain scale upon signing of the consent, after 1 month, after two months of treatment and after 1 month from the suspension of PEACETIL using the following questionnaires: * Numerical Rating Scale (NRS); * Visual Rating Scale (VAS); * DN4 questionnaire.

You may qualify if:

• Patients with new or recent diagnosis of acute or chronic neuropathic pain in which the clinician decides to introduce treatment with PEACETIL according to common clinical practice, belonging to one of the following categories:
• Dysmetabolic polyneuropathy (e.g. diabetic neuropathy),
• Chemotherapy treatment neuropathy,
• Compressive mononeuropathy,
• Radiculopathy,
• Postherpetic and non-postherpetic trigeminal neuralgia;
• The patient must be able to understand the informed consent of the study;
• Must adhere to the procedures established by the study;
• DN4 score \>4 at T0 (month 0);

You may not qualify if:

• Neurological disorders confounding the primary objective;
• Clinical condition which during the observational study requires the introduction or modification of the dosage of drugs which are also indicated for the treatment of acute or chronic pain
• Introduction or modification of the dosage of drugs used to treat acute and chronic neuropathic pain (including other nutraceuticals) from 30 days before the start of the study until the end of the study.
• Presence of unstable psychiatric illness, cognitive impairment, dementia, or substance abuse that would compromise the participant's ability to provide informed consent, as judged by the investigator;
• Clinically significant unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, serious laboratory test abnormality, or clinically significant ECG changes) that would pose a risk to the participant if they were to participate in the study, in the judgment of the 'investigator.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (3)

Istituto Auxologico Italiano

Milan, Lombardy, 20149, Italy

Location

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

Location

Fondazione Don Carlo Gnocchi ONLUS

Milan, Italy

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 21, 2024
• Study Start: June 9, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

IT (3)