CLINICAL TRIAL

Spinal Cord Stimulation for Trunk Pain

Recruiting · 18+ · All Sexes · Cape Girardeau, MO

This study is evaluating whether a device which delivers electrical stimulation to the spinal cord may help reduce pain.

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About the trial for Trunk Pain

Eligible Conditions
Trunk Pain · Limb Pain

Treatment Groups

This trial involves 2 different treatments. Spinal Cord Stimulation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Spinal Cord Stimulation
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2014
Completed Phase 4
~70

Side Effect Profile for Spinal Cord Stimulation

Spinal Cord Stimulation
Show all side effects
10%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
Device stimulation issue
10%
Inadequate analgesia
3%
Back pain
3%
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT03284411) in the Spinal Cord Stimulation ARM group. Side effects include: Device stimulation issue with 10%, Inadequate analgesia with 3%, Back pain with 3%.

Eligibility

This trial is for patients born any sex aged 18 and older. 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:
Willing and able to comply with all study procedures, including diary completion, and visits
Able to differentiate between pain associated with the indication for SCS implant and other types of pain
22 years of age or older
Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months
Willing and able to provide signed and dated informed consent
Capable of comprehending and consenting in English
View All
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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 16 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 16 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 16 weeks.
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 Spinal Cord Stimulation will improve 1 primary outcome in patients with Trunk Pain. Measurement will happen over the course of 16 weeks.

Numeric pain rating scale
16 WEEKS
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once a day on a multi-day diary, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score from the last 7 days of the diary prior to the scheduled visit will be used for analysis.
16 WEEKS

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 is limb pain?

The pain usually has a psychological cause in most patients. The pain usually is worse on movement and in response to temperature. The diagnosis should be confirmed by laboratory tests.

Anonymous Patient Answer

Can limb pain be cured?

Most patients with limb pain and no alternative explanation have a diagnosis. These patients can often be treated with anti-inflammatory medications and/or physiotherapy, and the pain often disappears. While this intervention can produce relief for some people, the high success rate is the same without these interventions, supporting the view that limb pain is a common complaint, for which diagnosis and treatment is normal.

Anonymous Patient Answer

What are common treatments for limb pain?

A few treatments are commonly used to treat limb pain, and the treatments are usually effective. For example, some treatments, such as NSAIDs and muscle relaxants, can be used to assist with muscle soreness. Furthermore, some patients may benefit from surgery to help alleviate pain.\n\n- Sores\n- Fungus infection\n\n- Pregnant or lactating women should avoid salicylates. (Specifically, salicylic acid in any form.)\n\nA small amount of aspirin is often recommended by doctors for protection against heart attacks. However, over 40% of people taking aspirin for at least 21 days develop severe bleeding.

Anonymous Patient Answer

What causes limb pain?

Limb pain, particularly ipsilateral limb pain, is most often caused by inter-articular pathology. Chronic compartment syndrome may also cause chronic limb pain or may develop into such a condition. The mechanism of pain production in this group is unknown.

Anonymous Patient Answer

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

Limp pain and arthritis were classified by ICD-9, implying an overlap between diagnoses. These two entities represent a considerable burden to patients in the United States. The actual number of limb pain and arthritis cases is most likely to be at least double the number reported in this study.

Anonymous Patient Answer

What are the signs of limb pain?

Limb pain is frequently associated with other symptoms, and frequently associated with medical conditions other than cancer. Findings from a recent study suggests that limb pain may indicate pathology other than cancer.

Anonymous Patient Answer

What does spinal cord stimulation usually treat?

Patients with peripheral (as well as central) pain and functional limitation resulting from [spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) have variable neurologic recovery following stimulation of different nerves. There is scant evidence comparing what patients experience after treatment with spinal cord stimulation.

Anonymous Patient Answer

Have there been other clinical trials involving spinal cord stimulation?

This article presents the current data on the first clinical trial involving SCS conducted by the U.S. Veterans Health Administration. Although the trial was designed to confirm preliminary findings in previous studies and to compare current SCS devices to one another, a trend toward reduced pain scores was not observed. Further research in this area is warranted before SCS is recommended for widespread application.

Anonymous Patient Answer

Have there been any new discoveries for treating limb pain?

A large number of new drugs have been developed in recent years, and limb pain remains a challenge for pain relief. Recent studies of non-analgesic nonsteroidal anti-inflammatory drugs have found them to be ineffective in relieving the pain of limb pain.

Anonymous Patient Answer

What are the common side effects of spinal cord stimulation?

In this large cohort of patients, an array of both common and adverse effects is reported. As this study does not encompass the full range of this side effect spectrum, it is important that other centers performing SCS use patient-centered protocols and/or standardized rating systems to assure consistency of care, outcomes, and side effect reporting.

Anonymous Patient Answer

Is spinal cord stimulation safe for people?

SCS may be a viable treatment option for people with refractory chronic pain in a small number of patients. However, the safety of SCS remains unknown and awaits further large randomized controlled trials. SCS should not be considered a treatment option until the safety profile is clearly established.

Anonymous Patient Answer

How does spinal cord stimulation work?

Stimulating the S1 area with an implantable pulse generator may be effective in reducing axial pain in a majority of patients without obvious complications and has been well tolerated. Spinal cord stimulation may be an effective treatment for axial pain due to radicular pain resulting from an upper limb problem.

Anonymous Patient Answer
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