Osteoarthritis (OA)NCT07562750
Empowered Relief Study
A study testing Empowered Relief and "Self Management Strategies" handout in people with Osteoarthritis (OA), run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
"Empowered Relief" (ER) Intervention was developed by Beth Darnall, PhD at what is now the Stanford Pain Relief Innovations Lab. Our design is a randomized 3-arm study with test treatment, active control, and placebo arms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis (OA)
- What is being tested?
- Empowered Relief and "Self Management Strategies" handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 16 Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 or older who are eligible and interested in enrolling
Who cannot join
- Any records flagged "break the glass" or "research opt out"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cedars Sinai
Los Angeles, California, 90048
Jordan Bernstein, 551-497-3176, jordan.bernstein@cshs.org
About this study
Official title: Empowered Relief for Osteoarthritis (OA)
"Empowered Relief" (ER) Intervention was developed by Beth Darnall, PhD at what is now the Stanford Pain Relief Innovations Lab. Our design is a randomized 3-arm study with test treatment, active control, and placebo arms. Our goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the standard of care - group pain-CBT. Treatment allocation is randomized to minimize confounder effects. Statisticians performing analyses will be blinded.
The primary objective of this study is to evaluate the efficacy of Empowered Relief (a novel, single-session (2-hour), evidence-based online pain management class) on reducing pain burden and improving quality of life in patients with advanced osteoarthritis. Empowered Relief is designed to compress key cognitive behavioral therapy (CBT) skills, mindfulness principles, and pain neuroscience education into a brief, scalable format.
Read more
Specifically, the study aims to: Evaluate Clinical Outcomes: Determine whether the intervention reduces pain burden and enhances mobility.
Assess Psychological \& Behavioral Impact: Examine whether the intervention improves patient-reported understanding of pain, fosters self-efficacy, and increases perceived control, thereby promoting active engagement in their own pain management.
Subject Population: The subject population consists of adult patients diagnosed with advanced osteoarthritis (KL Grade 3-4) who have been deferred from total hip or total knee arthroplasty (THA/TKA). Deferment criteria for this population include existing medical, surgical, behavioral, or personal barriers that currently preclude them from undergoing joint replacement surgery. This population is particularly vulnerable to prolonged suffering, decreased mobility, and compounding psychosocial distress while managing severe somatic pain without immediate surgical options.
Main Research Procedures: The study will utilize a prospective, longitudinal design to measure the impact of the Empowered Relief intervention on the target population.
The main procedures include: Intervention Delivery: Eligible participants will complete the live Empowered Relief online class (via Zoom) with a certified instructor (Dr. Caryn Lindsey), a 2-hour intervention equipping them with accessible, evidence-based behavioral pain management skills.
Data Collection Schedule: Participants will be assessed at three distinct time points: Baseline (pre-intervention), 4-weeks post-treatment, and 8-weeks post-treatment.
- Conditions
- Osteoarthritis (OA)
- Being tested
- Empowered Relief, "Self Management Strategies" handout
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
2-hour pain management course
"Self Management Strategies" handoutBehavioural
"Self Management Strategies" is an educational handout from the US Pain Foundation
| Study group | Role | What they receive |
|---|---|---|
| Test Treatment | Experimental | Not described Receives: Behavioral: Empowered Relief |
| Educational Materials | Active comparator | Patients will be provided with a handout from the U.S. Pain Foundation titled "Self Management Strategies" Receives: Behavioral: "Self Management Strategies" handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Catastrophizing Scale (PCS)
Measured: Once at baseline, then at weeks 2, 4, 8, and 12.
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Questions related to pain, physical function, and depression.
Measured: Once at baseline, then at weeks 2, 4, 8, and 12
Pain Self-Efficacy Questionnaire
Measured: Once at baseline, then at weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start14 Apr 2026 (estimated)
- Primary completion14 Apr 2028 (estimated)
- Study completion16 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA)Studies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caryn Lindsey, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562750
- Sponsor's protocol ID
- STUDY00004779
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wertli MM, Burgstaller JM, Weiser S, Steurer J, Kofmehl R, Held U. Influence of catastrophizing on treatment outcome in patients with nonspecific low back pain: a systematic review. Spine (Phila Pa 1976). 2014 Feb 1;39(3):263-73. doi: 10.1097/BRS.0000000000000110.
PubMed 24253796Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
PubMed 19407734Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
PubMed 19204216
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowered Relief for Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT07562750
- Acronym / sponsor ID
- STUDY00004779
- Conditions
- Osteoarthritis (OA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 14 Apr 2026 (estimated)
- Primary completion
- 14 Apr 2028 (estimated)
- Study completion
- 16 Apr 2028 (estimated)
- First posted
- 1 May 2026 (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.
"Empowered Relief" (ER) Intervention was developed by Beth Darnall, PhD at what is now the Stanford Pain Relief Innovations Lab. Our design is a randomized 3-arm study with test treatment, active control, and placebo arms. Our goals are to provide scientific evidence to demonstrate the efficacy of ER, and also provide a comparison of said efficacy against the standard of care - group pain-CBT. Treatment allocation is randomized to minimize confounder effects. Statisticians performing analyses will be blinded.
The primary objective of this study is to evaluate the efficacy of Empowered Relief (a novel, single-session (2-hour), evidence-based online pain management class) on reducing pain burden and improving quality of life in patients with advanced osteoarthritis. Empowered Relief is designed to compress key cognitive behavioral therapy (CBT) skills, mindfulness principles, and pain neuroscience education into a brief, scalable format.
Specifically, the study aims to: Evaluate Clinical Outcomes: Determine whether the intervention reduces pain burden and enhances mobility.
Assess Psychological \& Behavioral Impact: Examine whether the intervention improves patient-reported understanding of pain, fosters self-efficacy, and increases perceived control, thereby promoting active engagement in their own pain management.
Subject Population: The subject population consists of adult patients diagnosed with advanced osteoarthritis (KL Grade 3-4) who have been deferred from total hip or total knee arthroplasty (THA/TKA). Deferment criteria for this population include existing medical, surgical, behavioral, or personal barriers that currently preclude them from undergoing joint replacement surgery. This population is particularly vulnerable to prolonged suffering, decreased mobility, and compounding psychosocial distress while managing severe somatic pain without immediate surgical options.
Main Research Procedures: The study will utilize a prospective, longitudinal design to measure the impact of the Empowered Relief intervention on the target population.
The main procedures include: Intervention Delivery: Eligible participants will complete the live Empowered Relief online class (via Zoom) with a certified instructor (Dr. Caryn Lindsey), a 2-hour intervention equipping them with accessible, evidence-based behavioral pain management skills.
Data Collection Schedule: Participants will be assessed at three distinct time points: Baseline (pre-intervention), 4-weeks post-treatment, and 8-weeks post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Treatment | Experimental | Behavioral: Empowered Relief |
| Educational Materials | Active comparator | Behavioral: "Self Management Strategies" handoutPatients will be provided with a handout from the U.S. Pain Foundation titled "Self Management Strategies" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults age 18 or older who are eligible and interested in enrolling
Key exclusion criteria (1 listed)
- Any records flagged "break the glass" or "research opt out"
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 |
|---|---|---|
| Empowered Relief2-hour pain management course | Behavioural | Test Treatment |
| "Self Management Strategies" handout"Self Management Strategies" is an educational handout from the US Pain Foundation | Behavioural | Educational Materials |
Primary outcome
Pain Catastrophizing Scale (PCS)
Time frame: Once at baseline, then at weeks 2, 4, 8, and 12.
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: Once at baseline, then at weeks 2, 4, 8, and 12
Questions related to pain, physical function, and depression.
Pain Self-Efficacy Questionnaire
Time frame: Once at baseline, then at weeks 2, 4, 8, and 12
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 1 May 2026.
- Background: PubMed 24253796Wertli MM, Burgstaller JM, Weiser S, Steurer J, Kofmehl R, Held U. Influence of catastrophizing on treatment outcome in patients with nonspecific low back pain: a systematic review. Spine (Phila Pa 1976). 2014 Feb 1;39(3):263-73. doi: 10.1097/BRS.0000000000000110.
- Background: PubMed 19407734Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
- Background: PubMed 19204216Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief and "Self Management Strategies" handout in people with Osteoarthritis (OA), run by Cedars-Sinai Medical Center 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 May 2026. 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?
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 Jordan Bernstein (5514973176, jordan.bernstein@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Catastrophizing Scale (PCS) (time frame: Once at baseline, then at weeks 2, 4, 8, and 12.). The study lists 3 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 NCT07562750, 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 2026.