CLINICAL TRIAL

PICO G2 4k for Back Pain

Recruiting · Any Age · All Sexes · Los Angeles, CA

This study is evaluating whether a virtual reality program can help manage chronic lower back pain.

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About the trial for Back Pain

Eligible Conditions
Low Back Pain · Back Pain · Chronic Lower Back Pain (CLBP)

Treatment Groups

This trial involves 3 different treatments. PICO G2 4k 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.

Experimental Group 1
PICO G2 4k
DEVICE
Control Group 2
PICO G2 4k
DEVICE
Control Group 3
PICO G2 4k
DEVICE

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who are male or female and are above the age of 13. show original
The participant can use a personal computer or a smartphone to complete surveys that are web-based. show original
The study participants must provide a signed and dated informed consent form. show original
I am willing to comply with all the study procedures and I will be available for the entire study. show original
A back pain problem that has been persisting for at least 3 months and has resulted in pain on at least half the days in the past 6 months. show original
People who speak English. 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: The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.
Screening: ~3 weeks
Treatment: Varies
Reporting: The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study..
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 PICO G2 4k will improve 1 primary outcome, 5 secondary outcomes, and 4 other outcomes in patients with Back Pain. Measurement will happen over the course of biweekly basis until week 12.

Patient-Reported Outcomes Measurement Information System Physical Function 6b
BIWEEKLY BASIS UNTIL WEEK 12
For patients with chronic pain, physical function is often diminished and patients seek return to normal function. The Patient-Reported Outcomes Measurement Information System Physical Function short-form 6b scale is a widely- validated instrument with excellent content validity, construct validity, and reliability in patients with spinal disorders and other conditions marked by diminished mobility. The instrument places patients on a continuum of function from extremely low to very high across activities that require physical actions, ranging from self-care to more complex activities that require a combination of skills. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
BIWEEKLY BASIS UNTIL WEEK 12
Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a
BIWEEKLY UNTIL WEEK 12
Given the impact of chronic pain on mental health there is also an impact on sleep. PROMIS Sleep Disturbance is a well-validated survey to assess sleep quality. This is version A of the 6 item scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome.
BIWEEKLY UNTIL WEEK 12
Pain Catastrophizing Survey Short Form 6
BIWEEKLY UNTIL WEEK 12
Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. It will be measured using the Pain Catastrophizing scale (PCS) short form, which a 6-item questionnaire. The max score is 24 and the minimum is 0. The higher the score the worse the outcome.
BIWEEKLY UNTIL WEEK 12
Patient-Reported Outcomes Measurement Information System Anxiety 4
BIWEEKLY UNTIL WEEK 12
Anxiety is a commonly comorbid disease with chronic lower back pain. The PROMIS Anxiety scale will be used to assess it. This is the 4 question version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
BIWEEKLY UNTIL WEEK 12
Patient-Reported Outcomes Measurement Information System Depression 4
BIWEEKLY UNTIL WEEK 12
Depression is a commonly comorbid disease with chronic lower back pain. The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale will be used to assess it. This is the 4 item version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
BIWEEKLY UNTIL WEEK 12
Biometric data from Fitbit Charge 4 - Sleep Quantity
CONTINUOUSLY FROM WEEK 1 TO WEEK 12
The total hours of sleep per night as well as sleep efficiency will be assessed for the quantity of sleep using the Fitbit charge 4. Data will be analyzed using the Fitabase system.
CONTINUOUSLY FROM WEEK 1 TO WEEK 12
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Who is running the study

Principal Investigator
B. S.
Brennan Spiegel, Staff Physician III
Cedars-Sinai Medical Center

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 back pain a year in the United States?

Each year, around 12.8 million US adults are diagnosed with back pain. Back pain represents 27.9% of all visits to physicians and is the second most frequent reason for visiting a physician and is a cause of significant work missed by U.S. workers.

Anonymous Patient Answer

What are common treatments for back pain?

The majority of participants with back pain received conservative treatment of first resort, which included advice and education with a variety of nonpharmacological therapy with or without physical therapy and/or chiropractic care. Most common types of back pain treatment included analgesics, splints, and/or muscle care. There was little difference in the proportion of participants who received all the treatments for back pain, based on their indication.

Anonymous Patient Answer

Can back pain be cured?

Recent findings demonstrates that [back pain](https://www.withpower.com/clinical-trials/back-pain) can be managed effectively in a short time. This includes a significant decrease of the pain and fatigue intensity.

Anonymous Patient Answer

What causes back pain?

Though the cause of back pain is not entirely clear, various factors can contribute to it, including the mechanical stress associated with normal activities required of the body's muscles and nervous system, and internal or external body positions or postures, such as standing, bending over, or sitting. Though it often seems irrational or self-defeating to be excessively cautious when performing daily activities, people who have back pain should be cautious of their physical activities and body positions, as well as other contributing causes. These include exercise, prolonged or repetitive strain on the muscles or nerves of the back, smoking, physical trauma, poor posture, diet, lack of rest, and other underlying health problems. As people ages, the back becomes stiffer and less flexible.

Anonymous Patient Answer

What is back pain?

Back pain is the most common musculoskeletal complaint in the USA. The American Academy of Orthopaedic Surgeons (AAOS) and the American Spine Society (ASS) have published guidelines for treatment of back pain.

Anonymous Patient Answer

What are the signs of back pain?

The [back pain](https://www.withpower.com/clinical-trials/back-pain) of chronic or acute onset was common amongst the study population and this affected daily living for the majority of individuals. More than one-half of the individuals with chronic back pain or acute back pain complained of more specific pain in the lower back. The majority of the individuals with back pain were not able to achieve work that they needed but those who were able also stated other health problems.\nThe authors conclude that the back pain of this population may represent back pain with low or moderate disease severity with pain of moderate intensity and a duration of 6 months or more. The work-related, occupational and general health issues observed in this population can be explained by the presence of chronic back pain and the pain in other body areas.

Anonymous Patient Answer

What does pico g2 4k usually treat?

Achieving the best outcome following pico g2 4k treatment is challenging. Although there are a number of possible causes of [back pain](https://www.withpower.com/clinical-trials/back-pain), the vast majority of back pain patients respond well to pico g2 4k. By the 3-month evaluation more than 88% of patients who received pico g2 4k showed no signs of pain, only mild tenderness at the injection site. This level of success is an achievement of pico g2 4k treatment and is a reflection of its high effectiveness. Although these results can be improved by careful patient selection and close monitoring by the practitioner, pico g2 4k is a safe and effective treatment for chronic back pain.

Anonymous Patient Answer

Is pico g2 4k safe for people?

The Pico g2 4k is feasible with a low rate of complications for spinal surgery. More and longer studies are needed to further evaluate Pico g2 4K impact on a wider cohort of patients including those at high-risk.

Anonymous Patient Answer

Have there been any new discoveries for treating back pain?

In recent years, many research findings and articles have been published to help treat back pain. The two groups of drugs for the treatment of chronic low back pain (CLBP) that have been described are the selective serotonin reuptake inhibitors (SSRIs) and gabapentinoids, and the combination of gabapentinoid and a SSRI; gabapentin is also administered together with SSRIs in a different combination called triple therapy. These two medications are administered as prescribed by a provider; however, they can also be self-administered, which is done under the direction of a doctor. For those patients with ongoing back pain, self-administration is the recommended method of treatment.

Anonymous Patient Answer

Has pico g2 4k proven to be more effective than a placebo?

There was no difference in the improvement of self-reported back and neck pain between the Pico g2 4k and a placebo. Pico g2 4k is not an effective treatment for acute back pain. Pico g2 4k does not appear to offer an advantage over a placebo treatment. The study was registered on ClinicalTrials.gov. Identifier NCT00019901.

Anonymous Patient Answer

Have there been other clinical trials involving pico g2 4k?

The trial results indicate that there are no significant improvements to the use of PG4k over PG4 and that there are similar rates of patients with moderate or severe pain in all groups. The only difference that did occur was that there is a trend to show the patients in the PG4k group (3.0 to 2.6 cm) were more likely to report that they had decreased their pain in response to PG4k than PG4 (2.1 to 2.0 cm). It is important to observe carefully how the pain scale data is presented. In other words, there was an increase in the pain rating (pain) for subjects who took PG 4k as opposed to those taking PG4.

Anonymous Patient Answer

Who should consider clinical trials for back pain?

The general public seems to express a preference for high quality trials, that include rigorous and well-designed methods, such as randomized controlled trials to assess the true effect of clinical interventions on outcome.

Anonymous Patient Answer
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