Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain

Chronic Pain Clinical Trial

Official title:

N-of-1 Randomised Trials to Assess the Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699281
• Other study ID #: Nof1-PEA
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2019
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators planned to adopt the N-of-1 trial approach to objectively test the effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65 years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin will be eligible. Each trial will be a placebo-controlled randomized crossover trial including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average effect of um-PEA compared with placebo using a frequentist and Bayesian approach.

Description:

Background: Chronic pain in the elderly is highly prevalent, often underestimated, and associated with adverse outcomes. Most available analgesic drugs are often either ineffective or not tolerated, and burdened with many side effects. Palmitoylethanolamide (PEA) is an endogenous widely distributed N-acylethanolamina involved in neuroinflammation and pain generating processes. Formulations containing ultra-micronized Palmitoylethanolamide (um-PEA) are available on the market but their effectiveness on chronic pain in highly heterogeneous geriatric patients is not clear and likely not generalizable. Investigators planned to adopt the N-of-1 trial approach to objectively test the effectiveness of ultra-micronized PEA at an individual level in our older outpatients.

Methods/Design: 65 years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin will be eligible. Each trial will be a placebo-controlled randomized crossover trial including two um-PEA (600 mg twice a day) and placebo treatment pairs. um-PEA or placebo 3-week periods will be separated by 2-week washout intervals to overcome the possible carryover effect. Pain intensity, need for on-demand analgesic medications, and impact on daily activities will be evaluated. Also, cognitively impaired patients will be eligible as long as the expression of pain can be recognized and its frequency assessed by a caregiver. Trial results will be then discussed with the patient/caregiver and the treating physician to decide whether to continue the treatment. The impact of the N-of-1 approach on the physician's management plan and confidence will be assessed. Investigators will secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average effect of um-PEA compared with placebo using a frequentist and Bayesian approach.

Discussion: While pursuing an ultimate clinical objective, i.e. to empirically and objectively decide the best treatment choice for an individual older patient with chronic pain, these series of geriatric N-of-1 trials on PEA will bring the Evidence Based Medicine principles into the care of patients not usually represented in conventional randomized controlled trials, and realize a patient-centered outcome approach necessary to improve appropriate prescribing in elderly patients with multimorbidity and polypharmacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Pain is located at the back (any level) and/or at the joints and/or at the limbs.

• The pain is chronic, i.e. it has been present for at least 6 months, even if with fluctuations.

• The pain is attributable to one or more of the following conditions:

osteoarthritis/osteoarthrosis; spondylosis; radiculopathy; diabetic peripheral neuropathy; post-herpetic neuralgia; chronic idiopathic axonal polyneuropathy; fibromyalgia; or pain of uncertain origin or idiopathic, as long as it has had and it is expected to have a chronic nature, even if with spontaneous fluctuations.

Exclusion Criteria:

• cancer-related pain

• clear ischemic pathogenesis for pain (e.g. claudicatio intermittens or critical limb ischemia)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• ultra-micronized palmitoylethanolamide
ultra-micronized palmitoylethanolamide 600 mg twice a day
• Placebo
um-PEA like placebo twice a day

Locations

Country	Name	City	State
Italy	Geriatric Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily intensity of pain assessed using a 11-point visual numeric scale, accompanied with labels and pictures, modified from Faces Pain Scale.		126 days
Secondary	daily need of on-demand analgesic medications		126 days
Secondary	impact of pain on daily activities (short questionnaire modified from the back pain functional scale)	The short questionnaire modified from the back pain functional scale consists of 12 items (but it can be modified to better fit to the patients). A score from 1 to 5 is assigned to each item.	126 days