Experimental Pain in Parkinsons

NCT05981261 | Recruiting

• 1 other identifier: Experimental pain in PD
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Pain; Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Motor response latencies measure

  Prior to assessment of ongoing pain (3 minutes)

Study Arms (1)

Experimental pain

OTHER

Experimental pain

Other: inducement of experimental pain

Interventions

inducement of experimental pain OTHER

Inducement of experimental pain

Experimental pain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Group healthy volunteers: healthy subjects with no PD diagnosis
• Group PD patients levodopa: Include PD patients treated with levodopa

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

aarhus university Hospital

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Pain; Parkinson Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Andrea Søndergaard Poulsen, PhD student

CONTACT

+4561110138; andrea-s-p@hotmail.com

Lene Vase, Professor

CONTACT

lenevase@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: August 8, 2023
• Study Start: June 7, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)