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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614001274662

Enrollment

110

Registered

2014-12-05

Start date

2013-07-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 18 years old or over 2. Diagnosed with low back pain or low back pain plus leg pain for at least 6 months 3. Have current SCS implant (Boston Scientific) 4. 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 criteria

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

Outcome results