Pain, AcuteNCT05626582
Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults
A study testing pain delivery - learning only and pain delivery - learning and retention in people with Pain, Acute and Motor Activity, run by University of Delaware at 1 site in United States.
Trial summary
To date, the effects of pain on motor learning have not been thoroughly investigated. When examining potential effects on retention of motor learning, it is important to dissociate any effects of pain from effects of a context change. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Motor Activity
- What is being tested?
- pain delivery - learning only and pain delivery - learning and retention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- Self-identifying as generally medically healthy
- Able to read, write and speak English
- Able to provide informed consent
- Willing to undergo the experimental pain or non-painful electrical stimulation, if selected
Who cannot join
- Resting HR < 50 or > 100 bpm
- Resting BP < 90/60 or > 140/95 mmHg
- Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
- Score on the MoCA <23
- Score on the GAD-7 ≥ 10
- Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
Show all 19Show fewer
- Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis
- Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
- Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
- History of serious concussion or head injury, defined as a loss of consciousness for > 5 minutes and/or requiring medical treatment, or > 2 concussions over the lifespan
- Any history of acute or chronic problems with balance, any dizziness, or > 1 fall in the last 12 months
- Taking 4 or more medications
- Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.)
- Any current or chronic pain condition during the last year, located anywhere in the body
- Allergy to capsaicin or hot peppers
- Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
- Skin sensitivity to soaps/creams/perfumes or to heat
- Poor circulation in the area targeted for the painful stimulus
- Prior participation in a locomotor learning study in this lab within the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
To date, the effects of pain on motor learning have not been thoroughly investigated. When examining potential effects on retention of motor learning, it is important to dissociate any effects of pain from effects of a context change. The purpose of this research is to determine whether any altered retention of motor learning associated with acute pain is a true affect of pain or an affect of context (or both).
- Conditions
- Pain, Acute, Motor Activity
- Being tested
- pain delivery - learning only, pain delivery - learning and retention
- Keywords
- acute pain, young adults, pain, motor learning, motor consolidation, gait, locomotion, walking, generalization
- Medical subject headings
- Acute Pain, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain delivery - learning onlyProcedure or surgery
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin just during the Day 1 learning period.
pain delivery - learning and retentionProcedure or surgery
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin during the Day 1 learning period and again during the Day 2 retention period.
| Study group | Role | What they receive |
|---|---|---|
| Pain Stimulus - Learning Only | Experimental | Capsaicin combined with heat applied to intact skin Receives: Procedure: pain delivery - learning only |
| Pain Stimulus - Learning and Retention | Experimental | Capsaicin combined with heat applied to intact skin Receives: Procedure: pain delivery - learning and retention |
| No Stimulus | No intervention | Nothing applied to skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Retention Magnitude
degree to which the learned locomotor pattern has been remembered (in step length percent change, normalized to the amount learned from day 1)
Measured: 24 hours post learning (day 2)
Motor Learning Magnitude
degree to which the new locomotor pattern has been acquired (in step length percent change)
Measured: immediately after learning (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start11 Apr 2023
- Primary completion15 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Susanne M Morton, University of Delaware
- Investigators
- Susanne M Morton, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626582
- Sponsor's protocol ID
- 1786370-1.3
- Other IDs
- R01AG071585
- Status last verified
- Jul 2024
- First submitted
- 13 Nov 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults
- ClinicalTrials.gov ID
- NCT05626582
- Acronym / sponsor ID
- 1786370-1.3
- Conditions
- Pain, Acute, Motor Activity
- Keywords
- acute pain, young adults, pain, motor learning, motor consolidation, gait, locomotion, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 23 Nov 2022 (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.
To date, the effects of pain on motor learning have not been thoroughly investigated. When examining potential effects on retention of motor learning, it is important to dissociate any effects of pain from effects of a context change. The purpose of this research is to determine whether any altered retention of motor learning associated with acute pain is a true affect of pain or an affect of context (or both).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Stimulus - Learning Only | Experimental | Procedure: pain delivery - learning onlyCapsaicin combined with heat applied to intact skin |
| Pain Stimulus - Learning and Retention | Experimental | Procedure: pain delivery - learning and retentionCapsaicin combined with heat applied to intact skin |
| No Stimulus | No intervention | –Nothing applied to skin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-35 years old
- Self-identifying as generally medically healthy
- Able to read, write and speak English
- Able to provide informed consent
- Willing to undergo the experimental pain or non-painful electrical stimulation, if selected
Key exclusion criteria (19 listed)
- Resting HR < 50 or > 100 bpm
- Resting BP < 90/60 or > 140/95 mmHg
- Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
- Score on the MoCA <23
- Score on the GAD-7 ≥ 10
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 |
|---|---|---|
| pain delivery - learning onlyExperimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin just during the Day 1 learning period. | Procedure or surgery | Pain Stimulus - Learning Only |
| pain delivery - learning and retentionExperimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin during the Day 1 learning period and again during the Day 2 retention period. | Procedure or surgery | Pain Stimulus - Learning and Retention |
Primary outcome
Motor Retention Magnitude
Time frame: 24 hours post learning (day 2)
degree to which the learned locomotor pattern has been remembered (in step length percent change, normalized to the amount learned from day 1)
Motor Learning Magnitude
Time frame: immediately after learning (day 1)
degree to which the new locomotor pattern has been acquired (in step length percent change)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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. This study is not recruiting at the moment.
Susanne M Morton, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain delivery - learning only and pain delivery - learning and retention in people with Pain, Acute and Motor Activity, run by University of Delaware at 1 site in United States.
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 5 inclusion and 19 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: finished, as of the sponsor's last update on 12 Jul 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Retention Magnitude (time frame: 24 hours post learning (day 2)). The study lists 2 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 12 Jul 2024.