An interventional study of inducement of experimental pain in Pain and Parkinson Disease, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by University of Aarhus · Not applicable, Interventional, and Other
Study comparing pain intensity and discomfort in patients with Parkinson´s disease and healthy controls during inducement of mechanical, thermal, and chemical experimental pain
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 63 is close to the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Experimental pain
Other: inducement of experimental pain
Inducement of experimental pain
Thermal induced heat pain
Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: After assessment of motor response latencies measures (15 minutes)
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
Time frame: Prior to assessment of ongoing pain (3 minutes)
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jan 2027, 42 months after the start.
Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's planned 42 months is above that.
Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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