aarhus university Hospital
Aarhus, 8000, Denmark
Location status: Recruiting
NCT Number: NCT05981261
Study comparing pain intensity and discomfort in patients with Parkinson´s disease and healthy controls during inducement of mechanical, thermal, and chemical experimental pain
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Interventional
Not applicable
Aarhus, 8000, Denmark
Location status: Recruiting
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inducement of experimental pain
Time frame: Immediately after assessment of ongoing pain (15 minutes)
Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol
Time frame: Immediately after assessment of thermal induced heat pain (15 minutes)
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)
Time frame: Immediately after assessment of mechanical pain (15 minutes)
Chemical pain will be induced by an injection of hypertonic saline (HS, 5,8% in 1 ml)
Time frame: After assessment of motor response latencies measure (15 minutes)
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)
Time frame: After assessment of motor response latencies measures (15 minutes)
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).
Time frame: After assessment of motor response latencies measures (15 minutes)
Pain in PD will be assessed by King´s Parkinson´s disease pain scale (KPPS)
Time frame: Prior to assessment of ongoing pain (3 minutes)
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
Contact information is provided by the study sponsor or research team.
Andrea Søndergaard Poulsen, PhD student
CONTACT
Lene Vase, Professor
CONTACT
University of Aarhus
Other
Comparing Pain Intensity and Discomfort in Patients With Parkinson´s Disease and Healthy Controls During Inducement of Mechanical, Thermal, and Chemical Experimental Pain
Acronym: ExPainPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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