Pain, ChronicNCT03437460
The Economic and Cognitive Effects of Pain Reduction
A study testing Ibuprofen 600 mg and Prenatal vitamins in people with Pain, Chronic, run by University of Pennsylvania at 1 site in India.
Trial summary
Physical pain is a common but largely overlooked aspect of the lives of the poor. Not only does pain directly reduce life quality and happiness, it may also hamper cognitive function and, consequently, decision-making, productivity, and earnings. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Ibuprofen 600 mg and Prenatal vitamins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteIndia
- Study dates
- 10 May 2017to 12 Aug 2017
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be between the ages of 25 and 65
- Must speak Tamil as their primary language
- Must report that they have suffered from chronic physical pain in the last week.
Who cannot join
- An adverse relation related to pain medication in the past
- Kidney disease (ongoing or kidney stone within the past 3 years)
- Gastrointestinal (GI) discomfort
- History of complicated peptic ulcer disease
- Currently using NSAIDs, aspirin, corticosteroids or anticoagulants
- Allergies to any of the medicines use in the study
Show all 18Show fewer
- History of gastric bleeding
- History or existing liver disease
- Surgery within 1 to 2 weeks after the study
- Hypertension
- Heart disease or failure
- Diabetes
- Lupus
- Blood clotting
- Actual or potential pregnancy
- Use of contraindicated medications (including anticoagulants)
- Suicidal thoughts
- Consumption of more than 14 alcoholic beverages a week.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute for Financial Management and Research
Chennai, Tamil Nadu, 600034
About this study
Physical pain is a common but largely overlooked aspect of the lives of the poor. Not only does pain directly reduce life quality and happiness, it may also hamper cognitive function and, consequently, decision-making, productivity, and earnings. Workers with chronic pain may work fewer days, take longer breaks, and make less-considered choices regarding inputs; all outcomes that would reduce output and lead to greater impoverishment or impede the productivity and profitability of microenterprises and firms. The investigators will take the first steps in understanding the broader causal impact of physical pain on the cognitive and economic lives of the poor via a randomized controlled trial (RCT). 450 low-income women in Chennai, India, will be assigned to one of three treatment arms: 600 mg of over-the-counter pain medication, a placebo pill, or no medication. The research will quantify the causal impact of reduced pain on previously unstudied outcomes essential to escaping poverty including cognitive function, productivity, and earnings.
Read the detailed description
The investigators propose to evaluate the effect of reductions in chronic physical pain on cognitive function and productivity among poor individuals via a simple intervention using over-the-counter (OTC) pain medication. To do this, the investigators will enroll 450 low-wage female workers in Chennai, India into a two-day randomized controlled trial in which 150 randomly selected participants will receive OTC Non-steroidal Anti-inflammatory Drugs (NSAIDs; namely, Ibuprofen) at FDA-approved levels of one dose of 600 mg each on a single day, 150 participants will receive a placebo pill, and 150 participants will serve as a no-treatment control group.
Participants will complete a detailed survey, a battery of cognitive tests, pain measurements, a task to objectively scale each participant's pain assessments, and a task designed to measure economic productivity as detailed below.
Study location:
The study will be based at the Behavioral and Development Economics Lab in Chennai, India, founded by PIs Schofield and Schilbach in conjunction with a local institution, the Institute for Financial Management and Research (IFMR).
Sample:
Participants will consist of female flower stringers in Chennai, India. Flower stringers are self-employed individuals typically working on the streets. These women purchase flowers in the morning, string them together, and sell the strands to customers passing by. Their average daily income is Rs. 250-500 (approximately $4-9). Preliminary survey evidence suggests a higher prevalence of physical pain among older individuals; hence, this study will limit enrollment to individuals aged 25 to 65 years. The investigators focus on this population for several additional reasons. First, the nature of their work (stringing flowers while sitting on the floor for most of the day) causes high levels of pain. Second, due to the societal norms in the area, women do not regularly consume significant amounts of alcohol, substantially lowering the risks associated with taking pain medication. Third, the nature of their work makes flower stringers' productivity easily measurable (length and weight of flowers strung). Finally, although this population is specific, participants are similar in many ways (e.g. age, education, labor habits) to many workers in the informal sector, improving the study's external validity.
Recruitment and screening:
Surveyors approach potential participants at their place of work (typically a stand on the side of the street). The surveyor shares information about the study, while also conducting a broad first screen for eligibility. If participants are interested in participating and pass the initial screening, they schedule a time to come in to the lab for Day 1 (see below for further detail on the timing of the study). On Day 1, all potential participants are further screened to ensure: 1) their primary profession is flower-stringing, 2) they do not have any health conditions which are contraindicated for taking ibuprofen, 3) they regularly experience pain from their work, and 4) they are between the ages of 25 and 65.
Timing:
Day 1: Following field recruitment, potential participants are screened for eligibility and complete an informed consent process. If eligible, participants complete the survey measuring demographics, work habits, and data on the type and amount of pain typically experienced. Participants also complete the battery of cognitive assessments.
The investigators will randomize using Stata and then reveal the experimental condition assignment to individuals privately. Any non-compliance will be carefully tracked.
Day 2: Participants complete the battery of cognitive tasks and 30 minutes of flower stringing in the morning (pre-treatment). Participants report their pain levels periodically and complete a "pain calibration" by reporting their pain levels while holding their hand in cold water. They are then randomly assigned to one of the three experimental arms at lunch. After lunch, all participants complete another 3 hours of flower-stringing and repeat the battery of cognitive tasks. Participants also complete a "pain tolerance test" after lunch. In this task, participants are paid for the time they leave their hand in cold water.
- Conditions
- Pain, Chronic
- Being tested
- Ibuprofen 600 mg, Prenatal vitamins
- Keywords
- Productivity, Cognitive Function, Decision Making, Well-Being, Health, Labor
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
Also called Brufen
The investigators administer one single 600 mg dose of ibuprofen immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks.
Prenatal vitaminsDietary supplement
The investigators administer one single prenatal multivitamin immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 600mg | Active comparator | Treatment group participants receive a single 600 mg of over-the-counter ibuprofen. Receives: Drug: Ibuprofen 600 mg |
| Prenatal vitamins | Placebo comparator | The placebo group participants receive a single dose of a pre-natal multivitamin. Receives: Dietary Supplement: Prenatal vitamins |
| Control group | No intervention | Control-group participants are not provided with any treatment and they are fully informed regarding their treatment status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain levels - visual analog scale
Visual analog scale pain levels will measure the participant's self-assessed pain levels throughout the day. On the morning of Day 2 of the study, visual analog scale pain levels are recorded after each of the 4 cognitive tasks and after 30 minutes of flower stringing. Visual analog scale pain levels are reported throughout the afternoon of study Day 2 after each cognitive task and after every 30 minutes of flower stringing, and then compared to the baseline measures.
Measured: Change from baseline to end of Day 2
Change in pain levels - cold pressor task
Cold pressor task will measure the participant's pain tolerance. To assess a baseline tolerance, participants are asked to place their hand in cold water for 5 seconds to become accustomed to the task, and then for 20 seconds, after which they report their pain level. After lunch, participants complete the cold pressor duration, during which they hold their hand in cold water for as long as they want, up to 2 minutes. This measure is compared to the baseline measure from the morning.
Measured: Change from baseline to end of Day 2
Change in cognitive function: impulse control
The Hearts and Flowers task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Measured: Change from baseline to end of Day 2
Change in cognitive function: simple memory
The Corsi block-span task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Measured: Change from baseline to end of Day 2
Change in cognitive function: working memory
The N-back task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Measured: Change from baseline to end of Day 2
Change in cognitive function: simple attention
The Psychomotor Vigilance is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Measured: Change from baseline to end of Day 2
Change in flower-stringing productivity: weight of flower buds used
Flower stringing productivity (weight of buds used) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the weight of flower buds used in the afternoon flower stringing sessions, which span 150 minutes and 30 minutes.
Measured: Change from baseline to end of Day 2
Change in flower-stringing productivity: length of garland
Flower stringing productivity (length of garland) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the length of garland in the afternoon flower stringing sessions, which span 150 minutes and 30 minutes.
Measured: Change from baseline to end of Day 2
Change in flower-stringing productivity: density of garland
Flower stringing productivity (density of garland) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the density of garland in the afternoon flower stringing sessions, which span for 150 minutes and then for 30 minutes.
Measured: Change from baseline to end of Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start10 May 2017
- Primary completion12 Aug 2017
- Study completion12 Aug 2017
Why it stopped: Implementation issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Financial Management and Research
- Responsible party
- Principal investigator, Heather Schofield, University of Pennsylvania
- Investigators
- Frank Schilbach, Ph.D., Principal investigator, MIT Department of EconomicsHeather Schofield, Ph.D., Principal investigator, University of Pennsylvania, Perelman School of Medicine and Wharton Business SchoolAnuj Shah, Ph.D., Principal investigator, University of Chicago, Booth School of BusinessSendhil Mullainathan, Ph.D., Principal investigator, Harvard UniversityEmma Dean, M.S., Principal investigator, University of Pennsylvania, Wharton School of Business
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437460
- Sponsor's protocol ID
- 825454
- Status last verified
- Aug 2018
- First submitted
- 12 Jul 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Economic and Cognitive Effects of Pain Reduction
- ClinicalTrials.gov ID
- NCT03437460
- Acronym / sponsor ID
- 825454
- Conditions
- Pain, Chronic
- Keywords
- Productivity, Cognitive Function, Decision Making, Well-Being, Health, Labor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Implementation issues
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Institute for Financial Management and Research
- Study start
- 10 May 2017 (actual)
- Primary completion
- 12 Aug 2017 (actual)
- Study completion
- 12 Aug 2017 (actual)
- First posted
- 19 Feb 2018 (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.
Physical pain is a common but largely overlooked aspect of the lives of the poor. Not only does pain directly reduce life quality and happiness, it may also hamper cognitive function and, consequently, decision-making, productivity, and earnings. Workers with chronic pain may work fewer days, take longer breaks, and make less-considered choices regarding inputs; all outcomes that would reduce output and lead to greater impoverishment or impede the productivity and profitability of microenterprises and firms. The investigators will take the first steps in understanding the broader causal impact of physical pain on the cognitive and economic lives of the poor via a randomized controlled trial (RCT). 450 low-income women in Chennai, India, will be assigned to one of three treatment arms: 600 mg of over-the-counter pain medication, a placebo pill, or no medication. The research will quantify the causal impact of reduced pain on previously unstudied outcomes essential to escaping poverty including cognitive function, productivity, and earnings.
Detailed description
The investigators propose to evaluate the effect of reductions in chronic physical pain on cognitive function and productivity among poor individuals via a simple intervention using over-the-counter (OTC) pain medication. To do this, the investigators will enroll 450 low-wage female workers in Chennai, India into a two-day randomized controlled trial in which 150 randomly selected participants will receive OTC Non-steroidal Anti-inflammatory Drugs (NSAIDs; namely, Ibuprofen) at FDA-approved levels of one dose of 600 mg each on a single day, 150 participants will receive a placebo pill, and 150 participants will serve as a no-treatment control group.
Participants will complete a detailed survey, a battery of cognitive tests, pain measurements, a task to objectively scale each participant's pain assessments, and a task designed to measure economic productivity as detailed below.
Study location:
The study will be based at the Behavioral and Development Economics Lab in Chennai, India, founded by PIs Schofield and Schilbach in conjunction with a local institution, the Institute for Financial Management and Research (IFMR).
Sample:
Participants will consist of female flower stringers in Chennai, India. Flower stringers are self-employed individuals typically working on the streets. These women purchase flowers in the morning, string them together, and sell the strands to customers passing by. Their average daily income is Rs. 250-500 (approximately $4-9). Preliminary survey evidence suggests a higher prevalence of physical pain among older individuals; hence, this study will limit enrollment to individuals aged 25 to 65 years. The investigators focus on this population for several additional reasons. First, the nature of their work (stringing flowers while sitting on the floor for most of the day) causes high levels of pain. Second, due to the societal norms in the area, women do not regularly consume significant amounts of alcohol, substantially lowering the risks associated with taking pain medication. Third, the nature of their work makes flower stringers' productivity easily measurable (length and weight of flowers strung). Finally, although this population is specific, participants are similar in many ways (e.g. age, education, labor habits) to many workers in the informal sector, improving the study's external validity.
Recruitment and screening:
Surveyors approach potential participants at their place of work (typically a stand on the side of the street). The surveyor shares information about the study, while also conducting a broad first screen for eligibility. If participants are interested in participating and pass the initial screening, they schedule a time to come in to the lab for Day 1 (see below for further detail on the timing of the study). On Day 1, all potential participants are further screened to ensure: 1) their primary profession is flower-stringing, 2) they do not have any health conditions which are contraindicated for taking ibuprofen, 3) they regularly experience pain from their work, and 4) they are between the ages of 25 and 65.
Timing:
Day 1: Following field recruitment, potential participants are screened for eligibility and complete an informed consent process. If eligible, participants complete the survey measuring demographics, work habits, and data on the type and amount of pain typically experienced. Participants also complete the battery of cognitive assessments.
The investigators will randomize using Stata and then reveal the experimental condition assignment to individuals privately. Any non-compliance will be carefully tracked.
Day 2: Participants complete the battery of cognitive tasks and 30 minutes of flower stringing in the morning (pre-treatment). Participants report their pain levels periodically and complete a "pain calibration" by reporting their pain levels while holding their hand in cold water. They are then randomly assigned to one of the three experimental arms at lunch. After lunch, all participants complete another 3 hours of flower-stringing and repeat the battery of cognitive tasks. Participants also complete a "pain tolerance test" after lunch. In this task, participants are paid for the time they leave their hand in cold water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 600mg | Active comparator | Drug: Ibuprofen 600 mgTreatment group participants receive a single 600 mg of over-the-counter ibuprofen. |
| Prenatal vitamins | Placebo comparator | Dietary Supplement: Prenatal vitaminsThe placebo group participants receive a single dose of a pre-natal multivitamin. |
| Control group | No intervention | –Control-group participants are not provided with any treatment and they are fully informed regarding their treatment status. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be between the ages of 25 and 65
- Must speak Tamil as their primary language
- Must report that they have suffered from chronic physical pain in the last week.
Key exclusion criteria (18 listed)
- An adverse relation related to pain medication in the past
- Kidney disease (ongoing or kidney stone within the past 3 years)
- Gastrointestinal (GI) discomfort
- History of complicated peptic ulcer disease
- Currently using NSAIDs, aspirin, corticosteroids or anticoagulants
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 600 mgAlso: BrufenThe investigators administer one single 600 mg dose of ibuprofen immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks. | Drug | Ibuprofen 600mg |
| Prenatal vitaminsThe investigators administer one single prenatal multivitamin immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks. | Dietary supplement | Prenatal vitamins |
Primary outcome
Change in pain levels - visual analog scale
Time frame: Change from baseline to end of Day 2
Visual analog scale pain levels will measure the participant's self-assessed pain levels throughout the day. On the morning of Day 2 of the study, visual analog scale pain levels are recorded after each of the 4 cognitive tasks and after 30 minutes of flower stringing. Visual analog scale pain levels are reported throughout the afternoon of study Day 2 after each cognitive task and after every 30 minutes of flower stringing, and then compared to the baseline measures.
Change in pain levels - cold pressor task
Time frame: Change from baseline to end of Day 2
Cold pressor task will measure the participant's pain tolerance. To assess a baseline tolerance, participants are asked to place their hand in cold water for 5 seconds to become accustomed to the task, and then for 20 seconds, after which they report their pain level. After lunch, participants complete the cold pressor duration, during which they hold their hand in cold water for as long as they want, up to 2 minutes. This measure is compared to the baseline measure from the morning.
Change in cognitive function: impulse control
Time frame: Change from baseline to end of Day 2
The Hearts and Flowers task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Change in cognitive function: simple memory
Time frame: Change from baseline to end of Day 2
The Corsi block-span task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Change in cognitive function: working memory
Time frame: Change from baseline to end of Day 2
The N-back task is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Change in cognitive function: simple attention
Time frame: Change from baseline to end of Day 2
The Psychomotor Vigilance is completed once in the morning as a baseline measure and twice in the afternoon, to compare to the baseline. The task is compensated according to performance.
Change in flower-stringing productivity: weight of flower buds used
Time frame: Change from baseline to end of Day 2
Flower stringing productivity (weight of buds used) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the weight of flower buds used in the afternoon flower stringing sessions, which span 150 minutes and 30 minutes.
Change in flower-stringing productivity: length of garland
Time frame: Change from baseline to end of Day 2
Flower stringing productivity (length of garland) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the length of garland in the afternoon flower stringing sessions, which span 150 minutes and 30 minutes.
Change in flower-stringing productivity: density of garland
Time frame: Change from baseline to end of Day 2
Flower stringing productivity (density of garland) baseline is measured in the morning after a 30 minute flower stringing session. This outcome is compared to the density of garland in the afternoon flower stringing sessions, which span for 150 minutes and then for 30 minutes.
Results and safety
The study was stopped early (reason given: Implementation issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to other researchers upon request.
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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.
Frank Schilbach, Ph.D. principal investigator
MIT Department of Economics
Heather Schofield, Ph.D. principal investigator
University of Pennsylvania, Perelman School of Medicine and Wharton Business School
Anuj Shah, Ph.D. principal investigator
University of Chicago, Booth School of Business
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 600 mg and Prenatal vitamins in people with Pain, Chronic, run by University of Pennsylvania at 1 site in India.
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 18 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: stopped early, as of the sponsor's last update on 3 Aug 2018. 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 India. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Implementation issues). Results are not available in the source record.
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?
Change in pain levels - visual analog scale (time frame: Change from baseline to end of Day 2). The study lists 9 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 3 Aug 2018.