GeriatricLARKSPURNCT04869345
Positive Affect as a Source of Resilience for Adults in Chronic Pain
A study testing LARKSPUR in people with Geriatric and Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatric, Chronic Pain
- What is being tested?
- LARKSPUR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2021to 9 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Access to daily internet
- ≥ 50 years of age
- Able to read and understand English
- Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool
- Report having pain for at least the last three months
Who cannot join
- Cognitive impairment
- Current behavioral treatment for pain
- Enrolled in another pain study
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian - Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.
The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).
Read the detailed description
Specific Aims:
Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.
Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.
For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.
- Conditions
- Geriatric, Chronic Pain
- Being tested
- LARKSPUR
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARKSPURBehavioural
This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention.
| Study group | Role | What they receive |
|---|---|---|
| LARKSPUR intervention | Experimental | Lessons in Affect Regulation to Keep Stress and Pain UndeR control Receives: Behavioral: LARKSPUR |
| Attention Control Condition | No intervention | Daily emotion reporting/no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment as Measured by Rates of Enrollment (Aim 1)
Percent enrolled of total eligible participants.
Measured: At baseline
Retention as Measured by Change in Enrollment
Percentage enrolled at baseline that completed the post-intervention assessment.
Measured: At baseline; at week 11 (post-intervention)
Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1)
The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) "Would you recommend LARKSPUR to a friend?" and (2) "Would you recommend LARKSPUR to someone else with chronic pain?". Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined.
Measured: At week 11 (post-intervention)
Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)
Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.
Measured: At week 11 (post-intervention)
Secondary outcomes (8)
Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)
Pain intensity T-scores measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity over a 7-day recall period; the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 36.3 to 81.8. Lower T-scores represent better outcomes.
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)
Pain interference T-scores measured by PROMIS Pain Interference - Short Form 6b. This 6-item instrument measures self-reported impact of pain on a person's life and extent that pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Respondents report pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 41.0 to 78.3. Lower T-scores represent better outcomes.
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)
Physical function T-scores measured by PROMIS Physical Function Short Form 10a. This 10-item instrument assesses a patient's abilities and limitations with respect to everyday physical activities. Respondents report limitations on a 5-point scale: 5=Not at all, ..., 3=Somewhat, ..., 1=Cannot do, and abilities to perform activities on a 5-point scale: 5=Without any difficulty, ..., 3=With some difficulty, ..., 1=Unable to do. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 13.5 to 61.9. Higher T-scores represent better outcomes.
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)
Fatigue T-scores measured by PROMIS Fatigue Short Form 6a. This 6-item instrument assesses a patient's a patient's level of fatigue over a 7-day recall period. Respondents report fatigue on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. In the general population, T-scores have a mean of 50, standard deviation of 10, and range from 33.4 to 76.8. Lower T-scores represent better outcomes.
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)
The 10-item version of the Center for Epidemiological Studies Depression Scale (CES-D) asks for participants to rate how often over the past week they experienced symptoms associated with depression on a 4-point scale: 0=Rarely or None of the time, 1=Some or Little of the time, 2=Moderately or Much of the time, 3=Most or Almost all the time. CESD-R-10 mean scores range from 0 (rare depressive symptoms) to 4 (depressive symptoms most or almost all the time).
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2)
The modified Differential Emotions Scale (mDES) is a 20-item instrument that measures the extent to which a patient has experienced positive and negative emotions over a chosen time frame; in the version used in this study, we ask for emotions over the past 7 days. Respondents are asked to report the greatest amount of a given emotion on a five-point scale: 0=Not at all, 1=A little bit, 2=Moderately, 3=Quite a bit, 4=Extremely. mDES mean scores range from 0 (not at all experienced positive emotion) to 4 (extremely positive emotion).
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2)
The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 0=Very slightly or not at all, 1=A little, 2=Moderately, 3=Quite a bit, 4=Extremely. PANAS-GEN mean scores range from 0 (very slightly or not at all positive affect) to 4 (extremely positive affect).
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2)
The 10-item version of the Perceived Stress Scale (PSS) assesses the perception of stress over the previous month. Respondents report how often they have experienced perceived stress on a five-point scale: 0=Never, 1=Almost never, 2=Sometimes, 3=Fairly often, 4=Very often. PSS mean scores range from 0 (experienced no or minimal stress) to 4 (experienced very frequent stress).
Measured: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start27 Jul 2021
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GeriatricStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Cornell University, Wake Forest University
- Responsible party
- Sponsor
- Investigators
- Anthony Ong, PhD, Principal investigator, Cornell UniversityCary Reid, MD PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869345
- Sponsor's protocol ID
- 20-06022291
- Other IDs
- 5P30AG022845, 5U24AG058556
- Acronym
- LARKSPUR
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2021
- Last updated
- 1 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reduced, de-identified data sets containing data collected from patients, will be made available for secondary use at the National Archive of Computerized Data on Aging (NACDA), a division of ICPSR at the University of Michigan. NACDA is a repository of survey data on aging that has hundreds of social science research data sets available that are drawn from NIA-funded surveys and data collection efforts. NACDA has established protocols for contributors to reliably de-identify survey participants, regardless of whether they have been assembled as part of national random sample surveys or specialized registry data collection efforts. External users may be asked to provide study aims, variables requested, analytic plans, and targeted journals in their data use requests. They will also be asked to not attempt to re-identify participants, either by merging in administrative, census, medical, or other data, or by using a software program that might re-identify participants.
Publications
Ong AD, Moskowitz JT, Wethington E, Addington EL, Sanni M, Goktas S, Sluys E, Swong S, Kim P, Reid MC. Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia. Contemp Clin Trials. 2022 Sep;120:106880. doi: 10.1016/j.cct.2022.106880. Epub 2022 Aug 11.
PubMed 35964867Ong A, Wilcox K, Reid MC, Wethington E, Cintron D, Addington E, Goktas S, Moskowitz J. Targeting Daily Positive Events to Improve Emotional and Functional Well-Being in Adults With Fibromyalgia: Insights From the LARKSPUR Randomized Controlled Trial. J Med Internet Res. 2024 Dec 10;26:e54678. doi: 10.2196/54678.
PubMed 39657168Ong AD, Wilcox KT, Moskowitz JT, Wethington E, Addington EL, Sanni MO, Kim P, Reid MC. Feasibility, Acceptability, and Preliminary Efficacy of a Positive Affect Skills Intervention for Adults With Fibromyalgia. Innov Aging. 2023 Jul 13;7(10):igad070. doi: 10.1093/geroni/igad070. eCollection 2023.
PubMed 38094931
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Positive Affect Skills Intervention for Reducing Racial Disparities in Pain Management
- ClinicalTrials.gov ID
- NCT04869345
- Acronym / sponsor ID
- LARKSPUR / 20-06022291
- Conditions
- Geriatric, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Cornell University, Wake Forest University
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromyalgia syndrome (FMS) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (PA).Standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. Efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention.
The objectives of this Stage I randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (PA) skills intervention -LARKSPUR (Lessons in Affect Regulation to Keep Stress and Pain UndeR control)-in a sample of Hispanic, non-Hispanic other, and non-Hispanic African American patients with fibromyalgia syndrome (FMS).
Detailed description
Specific Aims:
Aim 1: To maximize relevance and acceptability of content and delivery of LARKSPUR intervention among patients with FMS, a chronic pain population with known deficits in PA. This aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent LARKSPUR intervention in Hispanic, non-Hispanic African American and non-Hispanic other patients with FMS.
Aim 2: To conduct a randomized pilot trial to evaluate the impact of the LARKSPUR intervention in FMS pain (primary outcome), as well PA, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and Aim 2a: explore racial/ethnic disparities.
For Aim 1, the study team will pilot LARKSPUR to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and Likert-scale items assessing satisfaction with the intervention and perceived helpfulness. For Aims 2, FMS patients (target N=90) will be randomized to receive the LARKSPUR content online or to complete daily emotion reports online (control). The researchers hypothesize that intervention participants will report more frequent PA, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced FMS pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LARKSPUR intervention | Experimental | Behavioral: LARKSPURLessons in Affect Regulation to Keep Stress and Pain UndeR control |
| Attention Control Condition | No intervention | –Daily emotion reporting/no intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Access to daily internet
- ≥ 50 years of age
- Able to read and understand English
- Physician diagnosis confirmation of FMS AND/OR Score ≥ 13 on the 6-item, self-report fibromyalgia screening tool
- Report having pain for at least the last three months
Key exclusion criteria (3 listed)
- Cognitive impairment
- Current behavioral treatment for pain
- Enrolled in another pain study
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 |
|---|---|---|
| LARKSPURThis intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention. | Behavioural | LARKSPUR intervention |
Primary outcome
Recruitment as Measured by Rates of Enrollment (Aim 1)
Time frame: At baseline
Percent enrolled of total eligible participants.
Retention as Measured by Change in Enrollment
Time frame: At baseline; at week 11 (post-intervention)
Percentage enrolled at baseline that completed the post-intervention assessment.
Helpfulness, Satisfaction, and Impact as Assessed by Self-Report Participant Feedback Survey (Aim 1)
Time frame: At week 11 (post-intervention)
The feedback survey collected two Likert-scale questions asking whether the participant recommends the intervention: (1) "Would you recommend LARKSPUR to a friend?" and (2) "Would you recommend LARKSPUR to someone else with chronic pain?". Both questions were measured on an 11-point scale, with 0=Definitely Not to 10=Definitely Yes. Higher scores indicate better outcomes for both questions. The two items were analyzed separately, not combined.
Length of Intervention Time as Measured by Number of Weeks to Complete Intervention (Aim 1)
Time frame: At week 11 (post-intervention)
Length of Intervention time as measured by number of weeks the participant took to complete the LARKSPUR intervention program.
8 secondary outcomes
Change in FMS Pain as Measured by PROMIS Pain Intensity - Short Form 3a (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in FMS Pain as Measured by PROMIS Pain Interference - Short Form 6b (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Physical Functioning as Measured by PROMIS Physical Functioning Short Form 10a (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Physical Functioning as Measured by PROMIS Fatigue - Short Form 6a (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Depressive Symptoms as Measured by the Center for Epidemiologic Studies Depression Scale Revised (CESD-R-10) (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Positive Affect as Measured by the Modified Differential Emotions Scale (mDES) (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Positive Affect as Measured by the Positive and Negative Affect Scale (PANAS-GEN) (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Change in Stress Appraisal as Measured by the Perceived Stress Scale (Aim 2)
Time frame: At baseline; at week 11 (post-intervention); at week 16 (1 month post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35964867Ong AD, Moskowitz JT, Wethington E, Addington EL, Sanni M, Goktas S, Sluys E, Swong S, Kim P, Reid MC. Lessons in Affect Regulation to Keep Stress and Pain UndeR control (LARKSPUR): Design of a randomized controlled trial to increase positive affect in middle-aged and older adults with fibromyalgia. Contemp Clin Trials. 2022 Sep;120:106880. doi: 10.1016/j.cct.2022.106880. Epub 2022 Aug 11.
- Derived from this study: PubMed 39657168Ong A, Wilcox K, Reid MC, Wethington E, Cintron D, Addington E, Goktas S, Moskowitz J. Targeting Daily Positive Events to Improve Emotional and Functional Well-Being in Adults With Fibromyalgia: Insights From the LARKSPUR Randomized Controlled Trial. J Med Internet Res. 2024 Dec 10;26:e54678. doi: 10.2196/54678.
- Derived from this study: PubMed 38094931Ong AD, Wilcox KT, Moskowitz JT, Wethington E, Addington EL, Sanni MO, Kim P, Reid MC. Feasibility, Acceptability, and Preliminary Efficacy of a Positive Affect Skills Intervention for Adults With Fibromyalgia. Innov Aging. 2023 Jul 13;7(10):igad070. doi: 10.1093/geroni/igad070. eCollection 2023.
- This manuscript describes the study design and anticipated analyses for this trial.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Reduced, de-identified data sets containing data collected from patients, will be made available for secondary use at the National Archive of Computerized Data on Aging (NACDA), a division of ICPSR at the University of Michigan. NACDA is a repository of survey data on aging that has hundreds of social science research data sets available that are drawn from NIA-funded surveys and data collection efforts. NACDA has established protocols for contributors to reliably de-identify survey participants, regardless of whether they have been assembled as part of national random sample surveys or specialized registry data collection efforts. External users may be asked to provide study aims, variables requested, analytic plans, and targeted journals in their data use requests. They will also be asked to not attempt to re-identify participants, either by merging in administrative, census, medical, or other data, or by using a software program that might re-identify participants.
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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.
Anthony Ong, PhD principal investigator
Cornell University
Cary Reid, MD PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARKSPUR in people with Geriatric and Chronic Pain, run by Weill Medical College of Cornell University 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 3 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 1 May 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 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?
Yes. Results are posted in the registry (first posted 1 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment as Measured by Rates of Enrollment (Aim 1) (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869345, which also lists 3 linked publications.
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 1 May 2023.