PainExPainPDNCT05981261
Experimental Pain in Parkinsons
A study testing inducement of experimental pain in people with Pain and Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Parkinson Disease
- What is being tested?
- inducement of experimental pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jun 2023to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lene Vase, Professor contact
Denmark1 site, 1 recruiting
- Recruiting
aarhus university Hospital
Aarhus, 8000
Andrea Søndergaard Poulsen, +4561110138, andrea-s-p@hotmail.com
About this study
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 comparing pain intensity and discomfort in patients with Parkinson´s disease and healthy controls during inducement of mechanical, thermal, and chemical experimental pain
Read the 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.
- Conditions
- Pain, Parkinson Disease
- Being tested
- inducement of experimental pain
- Medical subject headings
- Pain, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inducement of experimental painOther
Inducement of experimental pain
| Study group | Role | What they receive |
|---|---|---|
| Experimental pain | Other | Experimental pain Receives: Other: inducement of experimental pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal induced heat pain
Thermal heat detection and pain thresholds will be measured following the standardized "Quantitative Sensory Testing" protocol
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: After assessment of motor response latencies measures (15 minutes)
Secondary outcomes (1)
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
Measured: Prior to assessment of ongoing pain (3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start7 Jun 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981261
- Sponsor's protocol ID
- Experimental pain in PD
- Acronym
- ExPainPD
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05981261
- Acronym / sponsor ID
- ExPainPD / Experimental pain in PD
- Conditions
- Pain, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental pain | Other | Other: inducement of experimental painExperimental pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inducement of experimental painInducement of experimental pain | Other | Experimental pain |
Primary outcome
Thermal induced heat 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
Mechanical induced pain
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)
Chemical induced pain
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)
Ongoing pain (Clinical pain in daily life)
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)
Ongoing pain (Sensory and affective verbal descriptions of pain and patient drawings)
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).
Ongoing pain (Pain in PD)
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)
1 secondary outcome
Motor response latencies measure
Time frame: Prior to assessment of ongoing pain (3 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lene Vase, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inducement of experimental pain in people with Pain and Parkinson Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Søndergaard Poulsen, PhD student (+4561110138, andrea-s-p@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal induced heat pain (time frame: Immediately after assessment of ongoing pain (15 minutes)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.