RecruitingACTRN12614001274662

An investigation of the therapeutic effect of electrical impulses with short pulse width on pain relief and quality of the spinal cord stimulation in patients with intractable back and/or leg pain.


Sponsor

Dr. Paul Verrills

Enrollment

110 participants

Start Date

Jul 15, 2013

Study Type

Observational

Conditions

Summary

Prospective, observational study. Subjects who have inadequate pain relief from their currently implanted conventional spinal cord stimulator (Boston Scientific Corp.) will be evaluated for eligibility in this study. The study aims at investigating alternative programming combinations for these spinal cord devices. The programming algorithms are within the currently approved limits for the device. We hope to reduce the stimulation (paraesthesia) to a level in which it is no longer felt by the patient (subthreshold stimulation) but still provides improved pain relief and prolonged optimal therapy for patients with chronic back and leg pain. The potential outcomes of this project have vast applications in chronic pain patients, where patients will often tolerate side effects such as uncomfortable stimulation sensations, so that their pain may be controlled.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

  • 18 years old or over
  • Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
  • Have current SCS implant (Boston Scientific)
  • Willing and able to complete protocol requirements including:
  • a. Willing and able to complete health questionnaires and pain scales as specified in the protocol
  • b. Willing and able to sign the study-specific Informed Consent form
  • c. Willing and able to operate SCS implant remote control

Exclusion Criteria1

  • Have plans to enrol in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study

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Interventions

This is an observational study of the effects of alternative programming options/combinations, as part of routine standard of care, on chronic intractable back and/or leg pain in patients currently i

This is an observational study of the effects of alternative programming options/combinations, as part of routine standard of care, on chronic intractable back and/or leg pain in patients currently implanted with the Boston Scientific Corporation spinal cord stimulator (BSC SCS). Patients will be followed up 7-10 days following re-programming, and then periodically, as per standard of care, throughout the entire study period (until the study is closed - approximately 24 months). No outcome assessments are conducted post 7-10 days.


Locations(1)

NSW,VIC, Australia

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ACTRN12614001274662