HealthyNCT03952715
Can Training Increase Reporting Accuracy and Study Power in Human Pain Trials
A study testing Ibuprofen 400 mg in people with Healthy and Placebo Response, run by University of Haifa at 1 site in Israel.
Trial summary
In previous studies, results of both the Focused Analgesia Selection Test (FAST) procedure, a method to assess pain-reporting accuracy, and the Evoked Pain Training (EPT) procedure, aimed to improve pain-reporting accuracy, correlated with the placebo response. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Placebo Response
- What is being tested?
- Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 17 Apr 2018to Jul 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of neurological, psychiatric, or chronic pain disorders.
- Have used at list once Ibuprofen, and not sensitive to NSAIDs.
- Ability to give informed consent, communicate, and understand the purpose and instructions of this study.
Who cannot join
- Presence of diagnosed psychiatric disorders, cognitive and /or neurological deficits.
- Use of analgesic, anti-depressant or anti-enxiayoltic medications on a regular basis (except for oral contraceptives).
- Pregnancy.
- Never used NSAIDs.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
University of Haifa, The Clinical Pain Innovation Lab
Haifa, 3498838
Roi Treister, PhD, 972-(0)4-6146214, treister.roi@gmail.com
About this study
In previous studies, results of both the Focused Analgesia Selection Test (FAST) procedure, a method to assess pain-reporting accuracy, and the Evoked Pain Training (EPT) procedure, aimed to improve pain-reporting accuracy, correlated with the placebo response. The objectives of the current project were to determine if EPT (1) increases pain reporting accuracy and (2) affect the placebo response in experimental pain study.
Read the detailed description
Analgesic trials suffer from low assay-sensitivity, and experts in the field are concerned that many previous negative analgesic trails might be regarded as failed trails. Major contributor to this concern is the large placebo response observed in analgesic clinical trials. Recent findings from the investigators group suggest that improving pain reporting accuracy could increase analgesic trials assay sensitivity by reducing the placebo response. In previous studies, the investigators developed the Focused Analgesia Selection Test (FAST), a method to assess pain reporting accuracy. Later on, the investigators developed the Evoked Pain Training (EPT), aimed to improve pain reporting accuracy. Both these methods constitute the core of this project. The objectives of the current project are to determine if subject training increases (1) pain reporting accuracy and (2) the power of an analgesic trial.
Summary of main methods This project objectives will be achieved by preforming a two-stage study. First, all subjects undergo baseline assessments, including assessment of pain reporting accuracy (the FAST procedure) (visit #1). Then, subjects enter the first study stage (training stage), in which half of study subjects (n=50) undergo training to improve pain reporting accuracy. The training comprise of three in-clinic visits (visits #2, 3, 4) in which subjects receive feedback on accuracy of pain reports in response to noxious stimuli of various intensities (the EPT procedure). The EPT is based on repeated application of the FAST procedure, while providing feedback to subjects in between applications. The other half of subjects (n=50) undergo a "shame-training". After completion of the training phase, all subjects enter an experimental cross-over study design (second study phase) comprised of two in-clinic visits (visits 5 and 6). In each of these two visits, subjects undergo a battery of experimental pain tests (pre-treatment assessment), take one of two pills (either Ibuprofen 400 mg or identical sugar pill) in a random order, wait approximately 1 hour, and then undergo the same pain tests again (post-treatment assessment).
- Conditions
- Healthy, Placebo Response
- Being tested
- Ibuprofen 400 mg, Placebo oral tablet
- Keywords
- Focus analgesia selection test (FAST), Experimental pain variability, Placebo effect, Evoked pain training (EPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mgDrug
Each subject will receive Ibuprofen once, in between two psycho-physical assessments. Between the drug intake and the second assessment the subject will have to wait for 40 minutes.
Placebo oral tabletDrug
Each subject will receive Placebo (sugar pill) once, in between two psycho-physical assessments. Between the placebo pill intake and the second assessment the subject will have to wait for 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Evoked pain training | Experimental | Not described Receives: Drug: Ibuprofen 400 mg; Drug: Placebo oral tablet |
| Control | Experimental | Not described Receives: Drug: Ibuprofen 400 mg; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reporting accuracy
Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable".
Measured: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes.
Change in experimental pain perception due to drug/placebo pill intake
Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable". The placebo effect (Δ) will be calculated as the difference between the mean NPS.
Measured: Mechanical and thermal stimuli before the drug/placebo (Pre-drug/placebo) until receiving the same stimuli 40 minutes after taking the drug/placebo pill (Post-drug/placebo).
Secondary outcomes (1)
Evoked pain training
Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable".
Measured: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes. There are 3 training visits, each training consists of 2 FAST procedure and last approximately 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start17 Apr 2018
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952715
- Sponsor's protocol ID
- 016/18
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Training Increase Reporting Accuracy and Study Power in Human Pain Trials
- ClinicalTrials.gov ID
- NCT03952715
- Acronym / sponsor ID
- 016/18
- Conditions
- Healthy, Placebo Response
- Keywords
- Focus analgesia selection test (FAST), Experimental pain variability, Placebo effect, Evoked pain training (EPT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 16 May 2019 (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.
In previous studies, results of both the Focused Analgesia Selection Test (FAST) procedure, a method to assess pain-reporting accuracy, and the Evoked Pain Training (EPT) procedure, aimed to improve pain-reporting accuracy, correlated with the placebo response. The objectives of the current project were to determine if EPT (1) increases pain reporting accuracy and (2) affect the placebo response in experimental pain study.
Detailed description
Analgesic trials suffer from low assay-sensitivity, and experts in the field are concerned that many previous negative analgesic trails might be regarded as failed trails. Major contributor to this concern is the large placebo response observed in analgesic clinical trials. Recent findings from the investigators group suggest that improving pain reporting accuracy could increase analgesic trials assay sensitivity by reducing the placebo response. In previous studies, the investigators developed the Focused Analgesia Selection Test (FAST), a method to assess pain reporting accuracy. Later on, the investigators developed the Evoked Pain Training (EPT), aimed to improve pain reporting accuracy. Both these methods constitute the core of this project. The objectives of the current project are to determine if subject training increases (1) pain reporting accuracy and (2) the power of an analgesic trial.
Summary of main methods This project objectives will be achieved by preforming a two-stage study. First, all subjects undergo baseline assessments, including assessment of pain reporting accuracy (the FAST procedure) (visit #1). Then, subjects enter the first study stage (training stage), in which half of study subjects (n=50) undergo training to improve pain reporting accuracy. The training comprise of three in-clinic visits (visits #2, 3, 4) in which subjects receive feedback on accuracy of pain reports in response to noxious stimuli of various intensities (the EPT procedure). The EPT is based on repeated application of the FAST procedure, while providing feedback to subjects in between applications. The other half of subjects (n=50) undergo a "shame-training". After completion of the training phase, all subjects enter an experimental cross-over study design (second study phase) comprised of two in-clinic visits (visits 5 and 6). In each of these two visits, subjects undergo a battery of experimental pain tests (pre-treatment assessment), take one of two pills (either Ibuprofen 400 mg or identical sugar pill) in a random order, wait approximately 1 hour, and then undergo the same pain tests again (post-treatment assessment).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evoked pain training | Experimental | Drug: Ibuprofen 400 mg, Drug: Placebo oral tablet |
| Control | Experimental | Drug: Ibuprofen 400 mg, Drug: Placebo oral tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Absence of neurological, psychiatric, or chronic pain disorders.
- Have used at list once Ibuprofen, and not sensitive to NSAIDs.
- Ability to give informed consent, communicate, and understand the purpose and instructions of this study.
Key exclusion criteria (4 listed)
- Presence of diagnosed psychiatric disorders, cognitive and /or neurological deficits.
- Use of analgesic, anti-depressant or anti-enxiayoltic medications on a regular basis (except for oral contraceptives).
- Pregnancy.
- Never used NSAIDs.
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 |
|---|---|---|
| Ibuprofen 400 mgEach subject will receive Ibuprofen once, in between two psycho-physical assessments. Between the drug intake and the second assessment the subject will have to wait for 40 minutes. | Drug | Control, Evoked pain training |
| Placebo oral tabletEach subject will receive Placebo (sugar pill) once, in between two psycho-physical assessments. Between the placebo pill intake and the second assessment the subject will have to wait for 40 minutes. | Drug | Control, Evoked pain training |
Primary outcome
Pain reporting accuracy
Time frame: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes.
Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable".
Change in experimental pain perception due to drug/placebo pill intake
Time frame: Mechanical and thermal stimuli before the drug/placebo (Pre-drug/placebo) until receiving the same stimuli 40 minutes after taking the drug/placebo pill (Post-drug/placebo).
Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable". The placebo effect (Δ) will be calculated as the difference between the mean NPS.
1 secondary outcome
Evoked pain training
Time frame: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes. There are 3 training visits, each training consists of 2 FAST procedure and last approximately 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen 400 mg in people with Healthy and Placebo Response, run by University of Haifa at 1 site in Israel.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 May 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roi Treister, PhD (972-(0)4-6146214, treister.roi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reporting accuracy (time frame: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes.). 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 16 May 2019.