CLINICAL TRIAL

ElderTree on smart system (ET- SS) for Chronic Pain

Recruiting · 18+ · All Sexes · Madison, WI

ElderTree Smart System for Older Adults

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About the trial for Chronic Pain

Treatment Groups

This trial involves 3 different treatments. ElderTree On Smart System (ET- SS) is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
ElderTree on laptop (ET- LT)
BEHAVIORAL
Experimental Group 2
ElderTree on smart system (ET- SS)
BEHAVIORAL
Control Group 3
Treatment as usual (TAU)
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Have a chronic pain diagnosis AND a medical diagnoses of three or more of the following common chronic conditions: Chronic obstructive pulmonary disease (COPD), asthma, diabetes, hyperlipidemia, hypertension, ischemic heart disease, atrial fibrillation, heart failure, stroke, BMI 30+, cancer, chronic kidney disease, depression, osteoporosis, arthritis, or dizziness/falls/loss of vestibular function;
Be ≥60 years old;
Have been treated in University of Wisconsin (UW) Health clinics, with no plans to leave during the study period (only relevant for UW Health patients, not patients recruited from the community);
Be willing to share healthcare use (e.g. 30-day readmissions) in EHRs (only relevant for UW Health patients, not patients recruited from the community);
Allow researchers to share information about a patient's health status with their primary care physician (PCP).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 4 months, 8 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 4 months, 8 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 4 months, 8 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ElderTree on smart system (ET- SS) will improve 4 primary outcomes and 12 secondary outcomes in patients with Chronic Pain. Measurement will happen over the course of up to 8 months.

Number of participants with 30-day readmits
UP TO 8 MONTHS
Data will be collected from electronic health record
UP TO 8 MONTHS
Number of logons in ET per week
UP TO 8 MONTHS
Amount of ET use will be calculated by number of logons in the ET portal.
UP TO 8 MONTHS
Change in Lorig Health Distress Scale
BASELINE, 4 MONTHS, 8 MONTHS
Lorig Health Distress Scale is a self-reported measure. It has questions about how participant feel and how things have been during the past month. It is a 4 item scale. Each item can be score from 0-none of the time to 5- all the time. Higher scores corresponds to more amount of time the participant has been distressed about health (e.g., discouraged, worried, fearful, frustrated by health problems).
BASELINE, 4 MONTHS, 8 MONTHS
Change in PROMIS Short Form v1.0 - Depression 4a score
BASELINE, 4 MONTHS, 8 MONTHS
Participant reported measure of depression collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
BASELINE, 4 MONTHS, 8 MONTHS
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a score
BASELINE, 4 MONTHS, 8 MONTHS
Participant reported measure of anxiety, collected as a part of the PROMIS-29 v2.1 profile. There are four questions, with a possible score of four to 20. Higher scores indicate worse outcomes.
BASELINE, 4 MONTHS, 8 MONTHS
Change in PROMIS Pain Intensity Item
BASELINE, 4 MONTHS, 8 MONTHS
Participant reported measure of pain intensity, collected as a part of the PROMIS-29 v2.1 profile. This is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.
BASELINE, 4 MONTHS, 8 MONTHS
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes chronic pain?

Chronic pain syndromes have multiple possible causes which are often complex and difficult to identify. However, pain is caused by the perception of pain, which is processed in the sensory cortices. Pain processing can be affected by various factors such as genetics, physical health, or psychological health. The process of pain perception, however, is not dependent on these factors. The brain's pain pathways are relatively simple. Pain perception can be affected by diseases, such as cancer. There is no proof that a disease causes chronic pain but chronic pain is an important sign of illness. Chronic pain affects individuals in all ages. It is the most common symptom for a range of medical conditions.

Anonymous Patient Answer

How many people get chronic pain a year in the United States?

Almost two million people in the United States are affected by [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) at any given time, and there appear to be no differences in the prevalence of chronic pain by gender. The impact of chronic pain may be of great societal importance, as measured by the level of work disruption, pain-related disability, pain-related health care utilization, and overall disability.

Anonymous Patient Answer

Can chronic pain be cured?

Patients suffering from chronic non-cancerous pain have higher levels and more severe pain than patients free from pain. The levels and severity of pain decrease significantly during active treatment, most likely because of the reduction of pain sensitivity. This reduction is not explained by the opioid administration. In the light of recent research findings, the issue of the possible existence of persistent pain that will persist during remission needs to be settled.

Anonymous Patient Answer

What is chronic pain?

The common perception is that [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) is pain that cannot be controlled. Although pain may be difficult to control, our findings demonstrate that there is not always pain out of control. Understanding the cause of this and other pain may broaden treatment options.

Anonymous Patient Answer

What are common treatments for chronic pain?

Results from a recent paper reveals numerous potentially useful treatments for [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain), but the lack of high quality controlled research restricts assessment as a treatment option for chronic pain. The treatments listed in this review may be of benefit for individual patients by alleviating the experience of pain or distress. They may, however, not be suitable for some people.

Anonymous Patient Answer

What are the signs of chronic pain?

The symptoms of [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) are the same as those of other chronic non-cancer diseases with little or no cure options. To manage chronic pain, it is very important to get the patient to know the pain pattern so that they can start modifying their lifestyle, eating and alcohol habits from eating to alcohol to medication.

Anonymous Patient Answer

Is eldertree on smart system (et- ss) safe for people?

e-ss is a safe and feasible device for people when provided in a designated setting, as an alternative to traditional ambulatory care options such as conventional outpatient orthopaedics clinics. Its safety is enhanced by a multispecialty-based integrated team approach, patient coaching and follow-up care post-operatively. The effectiveness and safety of e-ss can improve patient outcomes and encourage access to other health care services. Clinicaltrials.gov N: NCT02238169.

Anonymous Patient Answer

How serious can chronic pain be?

As such, [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) poses a serious threat to the physical and psychological well being of a person. It is an indicator of much more serious, possibly life threatening, disease such as AIDS and cancer. Chronic pain is not simply a nuisance. It is not easily treatable and is an obstacle to social integration and fulfilling employment. Sufferers often feel they have no real choice but to seek medical and surgical intervention, to which the medical profession should refuse to administer opioids, and refuse to consider the possibility of alternative treatment which may be easier, less painful, and ultimately maybe safer.

Anonymous Patient Answer

What are the common side effects of eldertree on smart system (et- ss)?

There are a small number of common side effects in the smart system (et- ss) group: fatigue, decreased appetite, and insomnia. On the other hand, because we found there is no significant difference between the two treatment arms (et- ss and et-ss) after adjusting for baseline baseline symptoms and the presence or absence of common common side effect in the two treatment groups (et- ss versus et-ss), we found no sign that the presence of the et- ss treatment adds anything useful to the treatment of [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) and chronic fatigue. Therefore, we would say that et- ss is equally as safe as et- ss and we suggest its use for anyone with chronic fatigue or pain in which mental wellbeing is important.

Anonymous Patient Answer

Have there been any new discoveries for treating chronic pain?

No new discoveries for treating chronic pain have been made. The lack of evidence supports the hypothesis that chronic pain is caused by a dysfunctional opioid system and that the chronic pain itself is a secondary phenomenon resulting as a side effect of the dysfunction. It is our belief that most chronic pain treatments are overuse and ineffective.

Anonymous Patient Answer

Have there been other clinical trials involving eldertree on smart system (et- ss)?

There have been no clinical trials comparing the short term effects of et- ss to placebo. However, the et- ss trial has shown significant prolongation of pain relief compared to placebo, which is very encouraging. The clinical trial is still underway and it is expected to take another 3 years, therefore this treatment cannot be considered as a treatment that will provide quick relief for pain. Long term effects of et- ss are not known. The et- ss study has shown significant prolongation in average of pain from baseline to 12 months compared to placebo. It is expected that et- ss will not provide a long term solution to the pain that is experienced by many patients suffering from chronic pains.

Anonymous Patient Answer

What is the latest research for chronic pain?

The answer is NOT “NO evidence” and “very limited evidence” but “data”. In my opinion the term “data” is the best explanation for the “NO evidence” of what could be the new craze for “Chronic pain.” However, since there are more cures in the pipeline I feel that the new craze will be short lived. \n

Anonymous Patient Answer
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