CLINICAL TRIAL

Treatment for Chronic Pain

Refractory
Waitlist Available · 18+ · All Sexes · San Francisco, CA

This study is evaluating whether a brain stimulation device can be used to treat chronic pain.

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About the trial for Chronic Pain

Eligible Conditions
Phantom Limb Pain (PLP) · Phantom Limb · Chronic Pain · Neuralgia · Post Stroke Pain · Spinal Cord Injuries

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Medtronic Activa PC+S
DEVICE
Control Group 2
Medtronic Activa PC+S
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
site The text is about MRI scans for people with spinal cord injuries show original
not required This notice is to inform the public that the ability to speak or read English is not required for the position show original
This means that the person understands what they are consenting to, and also has all the information they need in order to make an informed decision. show original
The text discusses different types of pain that can be experienced after a stroke or spinal cord injury show original
nerves, is an appropriate preoperative workup A preoperative MRI done within one year that doesn't show any abnormalities near the target nerves is appropriate for someone who is experiencing Phantom limb pain. show original
Age ≥ 21 years
For patients with post-stroke pain who have an ischemic stroke, the MRI must show a lesion in the contralateral brainstem, thalamus, or cortex show original
One year or more of medically refractory severe pain (see below)
The average pain reported over the past thirty days is greater than five on a 0-10 numeric rating scale. show original
The patient has not responded adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic, with current stable doses of medications. show original
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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: 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years.
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 Treatment will improve 1 primary outcome, 3 secondary outcomes, and 7 other outcomes in patients with Chronic Pain. Measurement will happen over the course of 2 years.

Neuropathic Pain Questionnaire
2 YEARS
The Neuropathic pain Questionnaire (NPQ) is an assessment instrument for neuropathic pain intensity and quality. It contains 12 items: 10 related to sensations or sensory responses and two related to affect. The items are totaled and rated out of 12, with 12 being in the most neuropathic pain.
2 YEARS
Becks Depression Inventory
2 YEARS
The Becks Depression Inventory is commonly used assessment tools to quantify and track depression mood state over time. Its a single value outcome measurement ranging from 0 to 63, with 63 being the most depressed.
2 YEARS
NIH PROMIS toolbox (Patient Impression)
2 YEARS
The NIH PROMIS toolbox contains a host of survey questions tailored to measurement of specific disease states such as pain, global health and function. The patient impression evaluates patient self-evaluation and physician evaluation of the patient's general health ranging form 0 to 7 with 7 being the worst general health.
2 YEARS
Activity Tracker (Fitbit) - Activity (Steps)
2 YEARS
Each patient will be given a fitbit activity monitor which can record steps taken, flights of stairs climbed, heart rate and sleep quality. These measures will be used to infer functional improvement over time. Steps will be recorded as steps per hour or day and evaluated against changes in pain level reported in the VAS or NRS.
2 YEARS
Activity Tracker (Fitbit) - Activity (Sleep)
2 YEARS
Each patient will be given a fitbit activity monitor which can record steps taken, flights of stairs climbed, heart rate and sleep quality. These measures will be used to infer functional improvement over time. Sleep quality will be evaluated using the parameters (time in bed, time asleep, time in REM sleep, time in non-REM sleep, time awake).
2 YEARS
Quantitative Sensory Testing Pain Threshold
2 YEARS
The Quantative Sensory Testing machine is described in the research protocol, and uses thermal stimuli to measure pain sensitivity and thresholds which may change with time or therapy. Thermal stimuli down to 0 degrees F. and up to 55 degrees F are given and patients are asked to report their pain either qualitatively or quantitatively using numerical rating scale from 0 to 10, with 0 being the lowest/no pain, and 10 being the worst.
2 YEARS
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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.

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

around 15.7% of American adults have [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain), and this can be reduced by targeting interventions at individuals with chronic pain, addressing their pain, and/or reducing the consequences of chronic pain in society in general.

Anonymous Patient Answer

What are the signs of chronic pain?

Signs of [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) can be grouped as sensory, somatic, autonomic, psychological, or emotional. The pain may also be radicular. This is more important in the case of disabling pain. Disabling chronic pain can be treated with medication, physical therapy, counselling and exercise. In the majority of the cases (n=18) patients with chronic pain were satisfied with their decision to go on pain medicine treatment and experienced the treatment as effective.\n\nFor all sorts of disorders, not only are signs, but the signs also are of the most important part of the assessment by means of which the patient-centerly can be assessed and treated optimally.

Anonymous Patient Answer

Can chronic pain be cured?

The best results in [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) can be achieved with multimodal treatment including pain medication, physiotherapy, psychological therapy, and multidisciplinary approaches. More research is needed to understand the specific treatments most effective in reversing chronic pain.

Anonymous Patient Answer

What causes chronic pain?

It is generally accepted that [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) is related to both biological and psychological factors. Pain may be an indicator of a biological condition of the host, an indicator of a psychological condition of the patient, or both - but its occurrence, nature, and extent, vary greatly.

Anonymous Patient Answer

What are common treatments for chronic pain?

Nearly a quarter of chronic pain patients used medical professionals as the primary source of treatment for chronic pain. Medical professionals prescribe physical therapy, physiotherapy, and surgical procedures to address chronic pain.

Anonymous Patient Answer

What is chronic pain?

The definition of chronic pain has never been resolved in any of the scientific publications cited in this paper. It is often assumed that chronic pain in the absence of other associated symptoms is a normal one; a condition in some individuals that resolves on its own. However, there are more than 25 known reasons for chronic pain, that include neurological processes, emotional trauma and genetic factors. More than one definition of chronic pain is emerging. It comes to mind as a “disabling chronic pain syndrome” of unknown causation and pathophysiology that can and often does last an entire life...

Anonymous Patient Answer

What is the average age someone gets chronic pain?

A new age of onset for [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) seems to have moved back to the mid-1960's. The majority had their initial symptoms prior to adulthood. No particular risk factors were identified for age of onset of chronic pain. It is a matter of speculation that early-onset chronic pain might be linked to increased vulnerability to pain syndromes, psychiatric disease, or multiple pain treatments.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

A systematic review of studies with pain treatment as active comparator found no convincing evidence to support the idea that treatment is more effective than a placebo\no matter whether the treatments involved treatment or control, irrespective of whether or not the patients were informed that the treatment involved a placebo.

Anonymous Patient Answer

What does treatment usually treat?

In patients treated with regular medications, functional improvement was rarely observed. The most likely explanation for the discrepancy lies in the high rate of side effects in this patient population.

Anonymous Patient Answer

What is the latest research for chronic pain?

The information presented herein is a valuable tool for practitioners to consult. The authors and readers of this paper have tried to give as wide of a range of evidence as they could for each topic under investigation to allow the reader to make up their own mind. While this information and that presented will provide the general audience with an overview of what is being investigated, the real experts will have already seen more of this information in their daily practice with patients who have chronic pain and who are candidates for further research. The authors would thank those members of The Cochrane Group, The IADP Research Group, The CNCP Trial Group, and the PROFILES trial group for this supplementary information.

Anonymous Patient Answer

What is treatment?

“There is no answer that can bring one peace or comfort, but there are two important things we should focus on to find comfort,” according to a woman suffering from Fibromyalgia. She explained that “everything” that we need for treatment…even an understanding and an open mind…come from loving each other. “If we don’t understand each other, we don’t understand ourselves, and don’t understand our pain, it’s impossible to find comfort….

Anonymous Patient Answer

Who should consider clinical trials for chronic pain?

In a recent study, findings show that [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) patients want clinical trials in order to help understand how we can better treat them. However, they want to have an open discussion with investigators, discuss all risks and benefits, and understand the steps/processes involved before participation in clinical trials. They also want a better message about enrollment in clinical trials. They also want treatment from surgeons and other providers rather than clinical trials. They also want to be able to decide if treatment is a good idea for them. Most of the patients want clinical trials for treatment options that include acupuncture and chiropractic. Most of the patients want clinical trials that measure outcomes that include mood or quality of life rather than just pain.

Anonymous Patient Answer
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