Experimental Pain in Parkinsons (ExPainPD)

Comparing Pain Intensity and Discomfort in Patients With Parkinson´s Disease and Healthy Controls During Inducement of Mechanical, Thermal, and Chemical Experimental Pain

Study comparing pain intensity and discomfort in patients with Parkinson´s disease and healthy controls during inducement of mechanical, thermal, and chemical experimental pain

Study Overview

• Status: Recruiting
• Conditions: Pain; Parkinson Disease
• Intervention / Treatment: Other: inducement of experimental pain

Detailed Description

Project: Inducing experimental muscle pain in healthy volunteers, patients with Parkinson's disease in levodopa treatment, and patients with Parkinson's disease with deep brain stimulation treatment

Research team:

• Andrea S. Poulsen (PI), PhD-student, AU
• Sophie Rosenkjær, PhD-student, AU
• Lene Vase, Professor, AU
• Nanna B. Finnerup, Professor, AUH
• Mette Møller, Leading doctor, AUH
• Erisela Qerama Montvilas, Clinical lector, AUH
• Jan Rosner, Post-doc, AUH

Objective: Comparing induced pain levels in (1) healthy volunteers, (2) patients with Parkinson's disease in levodopa treatment, and (3) patients with Parkinson's disease with deep brain stimulation treatment

Participants: 21 healthy volunteers, 21 patients with Parkinson's disease in levodopa treatment, and 21 patients with Parkinson's disease with deep brain stimulation treatment will be recruited from the Department of Neurology at Aarhus University Hospital. Furthermore, recruitment sheets will be posted at Aarhus University Hospital, at Parkinsonforeningen's webpage (https://www.parkinson.dk/) and newsletter and in local newspapers. A power calculation for a Wilcoxcon-Mann-Whitney rank sum test (Three groups) determine 21 in three test groups is adequate (effect size= 0.8; 1-β=.80; α=.05).

Design:Between-subject randomized study where each participant will complete a ≈1 ½ hour test session at the Department of Neurophysiology, Aarhus University Hospital, Denmark. Each test session will include assessment of ongoing pain, experimental pain (thermal, mechanical, and chemical), and motor response latencies.

Procedure: Each test session proceeds as follow: First, participant is greeted in the entry hall at AUH and escorted to the examination room. Investigator goes through test procedures and introduce to assessments. Participant complete measures of ongoing pain followed by assessment of motor response latencies. Then, assessments of thermal heat detection, pain thresholds and pain-autonomic interactions on volar forearm. Next, sites of inducement of mechanical and chemical pain (randomized gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle) will be identified by use of manual palpation and defined by distinct anatomical landmarks marked with a pen. For each site: assessment of mechanical pain threshold followed by evaluation of intensity and discomfort during pain suprathreshold. Then, inducement of chemical pain by use of hypertonic saline injections. Immediately after injection, evaluation of pain intensity and discomfort followed by assessment of sensory and affective verbal descriptions of pain and patient drawings of pain size and distribution. Finally, measures of pain intensity and discomfort during mechanical suprathreshold pressure on site of injection. There will be a 15 minutes interval between inducement of experimental pain in the three sites for the pain to cease. Investigator escorts participant to the entry hall and thank participant for taking part in the study.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Søndergaard Poulsen, PhD student; Phone Number: +4561110138; Email: andrea-s-p@hotmail.com
• Study Contact Backup: Name: Lene Vase, Professor; Email: lenevase@psy.au.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Recruiting
    • Aarhus University Hospital
    • Contact: Andrea Søndergaard Poulsen; Phone Number: +4561110138; Email: andrea-s-p@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

• Group healthy volunteers: healthy subjects with no PD diagnosis
• Group PD patients levodopa: Include PD patients treated with levodopa
• Group PD patients DBS: Include PD patients with DBS Exclusion criteria
• Known other neurological or medical disorders (e.g., stroke, neuropathy, diabetes) or other disorders with expected influence on experimental pain
• Known dementia (a score <24 on the MoCA)
• Known untreated depression (a score ≥15 on the Beck Depression Inventory)
• Unable to cooperate
• Treated with painkillers except paracetamol and NSAID (except if pain and treatment is ad-equately stable as evaluated by a doctor)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental pain	Other: inducement of experimental pain; Inducement of experimental pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal induced heat pain	Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol	Immediately after assessment of ongoing pain (15 minutes)
Mechanical induced pain	Mechanical pain thresholds and suprathresholds will be measured by use of a handhold pressor algometer (Somedic, Hörby, Sweden) with a 1-cm2 probe placed on test muscle (gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle in a randomized order)	Immediately after assessment of thermal induced heat pain (15 minutes)
Chemical induced pain	Chemical pain will be induced by an injection of hypertonic saline (HS, 5,8% in 1 ml)	Immediately after assessment of mechanical pain (15 minutes)
Ongoing pain (Clinical pain in daily life)	Intensity and discomfort of ongoing pain in gluteus medius muscle, tibialis anterior muscle, and infraspinatus muscle will be assessed by use of 11- point Numeric Rating Scale (NRS)	After assessment of motor response latencies measure (15 minutes)
Ongoing pain (Sensory and affective verbal descriptions of pain and patient drawings)	Sensory and affective verbal descriptions of pain and patient drawings of pain size and distribution will be measured by use of the short-form McGill Pain Questionnaire (SF-MPQ).	After assessment of motor response latencies measures (15 minutes)
Ongoing pain (Pain in PD)	Pain in PD will be assessed by King´s Parkinson´s disease pain scale (KPPS)	After assessment of motor response latencies measures (15 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor response latencies measure	To control for bias due to reaction time in measures which include participant stop buttons, motor response latencies will be assessed by use of a response box	Prior to assessment of ongoing pain (3 minutes)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Experimental pain in PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No