Observational Post Market Study in Treating Chronic Upper Extremity Limb Pain

  • STATUS
    Recruiting
  • participants needed
    70
  • sponsor
    SGX Procura LLC
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Updated on 5 August 2020
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pain relief
analgesics
intractable pain

Summary

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Description

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM SCS programming approach.

Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

The expected total duration of this study is approximately 12 months. Enrollment of participants is expected to last 6 months. Participants that have received the permanent implant will be followed up for 3 months after their device has been activated. A participant will likely be committed to the study for about 5 months. This consists of Baseline assessments, up to 10 days of trial stimulation, and 3 months of treatment following implantation and activation of the device.

Details
Condition Pain, Pain, Upper Extremity, Acute Pain Service
Age 18years - 100years
Treatment Intellis neurostimulator system
Clinical Study IdentifierNCT04466111
SponsorSGX Procura LLC
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

A subject must MEET ALL of the following inclusion criteria
Be diagnosed with chronic, intractable pain of the upper limb related to the cervical spine and/or neuropathic arm pain
Be a candidate for SCS system (trial and implant) per labeled indication (upper limb pain due to one of the conditions listed in indications statement)
Considering daily activity and rest, has average upper limb pain intensity of 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
Be willing and capable of giving written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the subject's participation has been provided
Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
Be 18 years of age or older at the time of enrollment
Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
Be willing and able to comply with study -related requirements, procedures, and visits, including not increasing pain meds through the three month visit
Has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator

Exclusion Criteria

A subject must NOT MEET ANY of the following exclusion criteria
Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available IntellisTM SCS systems as determined by the Investigator
Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
Be concurrently participating in another clinical study
Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump
Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
Has significant cervical stenosis, as determined by the Investigator
Has facet spondylosis, as determined by the Investigator
Has mechanical spine instability, as determined by the Investigator
Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat upper limb pain, which is providing significant pain relief
Has unresolved major issues of secondary gain (e.g., social, financial, legal, such as worker compensation matters)
Be pregnant as determined by urine testing unless female subject is surgically sterile or post-menopausal. If female, sexually active, and childbearing age, subject must be willing to use a reliable form of birth control
Have evidence of an active disruptive psychological or psychiatric disorder as determined by a psychologist
Have a current diagnosis of a progressive neurological disease as determined by the Investigator
Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
Have a condition that the Investigator determines would significantly increase perioperative risk
Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
Have metastatic malignant disease or active local malignant disease
Have a life expectancy of less than 1 year
Have an active systemic or local infection
Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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