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Experimental Pain in Parkinsons (ExPainPD)

Primary Purpose

Pain, Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
inducement of experimental pain
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • aarhus university HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental pain

Arm Description

Experimental pain

Outcomes

Primary Outcome Measures

Thermal induced heat pain
Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol
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)
Chemical induced pain
Chemical pain will be induced by an injection of hypertonic saline (HS, 5,8% in 1 ml)
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)
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).
Ongoing pain (Pain in PD)
Pain in PD will be assessed by King´s Parkinson´s disease pain scale (KPPS)

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2023
Last Updated
July 31, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05981261
Brief Title
Experimental Pain in Parkinsons
Acronym
ExPainPD
Official Title
Comparing Pain Intensity and Discomfort in Patients With Parkinson´s Disease and Healthy Controls During Inducement of Mechanical, Thermal, and Chemical Experimental Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a within-subject design where each participant is exposed to experimental pain in infraspinatus muscle, gluteus medius muscle, and tibialis anteior muscle in a randomized order.
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental pain
Arm Type
Other
Arm Description
Experimental pain
Intervention Type
Other
Intervention Name(s)
inducement of experimental pain
Intervention Description
Inducement of experimental pain
Primary Outcome Measure Information:
Title
Thermal induced heat pain
Description
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)
Title
Mechanical induced pain
Description
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)
Title
Chemical induced pain
Description
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)
Title
Ongoing pain (Clinical pain in daily life)
Description
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)
Title
Ongoing pain (Sensory and affective verbal descriptions of pain and patient drawings)
Description
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)
Title
Ongoing pain (Pain in PD)
Description
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)
Secondary Outcome Measure Information:
Title
Motor response latencies measure
Description
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Søndergaard Poulsen, PhD student
Phone
+4561110138
Email
andrea-s-p@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Vase, Professor
Email
lenevase@psy.au.dk
Facility Information:
Facility Name
aarhus university Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Søndergaard Poulsen
Phone
+4561110138
Email
andrea-s-p@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Experimental Pain in Parkinsons

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