Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ultra-micronized palmitoylethanolamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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)
Sites / Locations
- Geriatric Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ultra-micronized Palmitoylethanolamide
Placebo
Arm Description
Ultra-micronized Palmitoylethanolamide 600 mg twice a day
Placebo tab twice a day
Outcomes
Primary Outcome Measures
daily intensity of pain assessed using a 11-point visual numeric scale, accompanied with labels and pictures, modified from Faces Pain Scale.
Secondary Outcome Measures
daily need of on-demand analgesic medications
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.
Full Information
NCT ID
NCT02699281
First Posted
February 21, 2016
Last Updated
September 10, 2019
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT02699281
Brief Title
Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
Official Title
N-of-1 Randomised Trials to Assess the Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultra-micronized Palmitoylethanolamide
Arm Type
Experimental
Arm Description
Ultra-micronized Palmitoylethanolamide 600 mg twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tab twice a day
Intervention Type
Drug
Intervention Name(s)
ultra-micronized palmitoylethanolamide
Other Intervention Name(s)
um-PEA, Normast
Intervention Description
ultra-micronized palmitoylethanolamide 600 mg twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
um-PEA like placebo
Intervention Description
um-PEA like placebo twice a day
Primary Outcome Measure Information:
Title
daily intensity of pain assessed using a 11-point visual numeric scale, accompanied with labels and pictures, modified from Faces Pain Scale.
Time Frame
126 days
Secondary Outcome Measure Information:
Title
daily need of on-demand analgesic medications
Time Frame
126 days
Title
impact of pain on daily activities (short questionnaire modified from the back pain functional scale)
Description
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.
Time Frame
126 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maura Marcucci, MD, MSc
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Unit, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29210011
Citation
Germini F, Coerezza A, Andreinetti L, Nobili A, Rossi PD, Mari D, Guyatt G, Marcucci M. N-of-1 Randomized Trials of Ultra-Micronized Palmitoylethanolamide in Older Patients with Chronic Pain. Drugs Aging. 2017 Dec;34(12):941-952. doi: 10.1007/s40266-017-0506-2.
Results Reference
derived
PubMed Identifier
27473188
Citation
Marcucci M, Germini F, Coerezza A, Andreinetti L, Bellintani L, Nobili A, Rossi PD, Mari D. Efficacy of ultra-micronized palmitoylethanolamide (um-PEA) in geriatric patients with chronic pain: study protocol for a series of N-of-1 randomized trials. Trials. 2016 Jul 29;17:369. doi: 10.1186/s13063-016-1496-9.
Results Reference
derived
Learn more about this trial
Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
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