Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain.
This is a feasibility study to identify the optimal frequency for stimulation of the spinal cord to achieve maximum reduction in neuropathic back pain as measured by average Numerical rating Scale. Twenty patients who suffer from back more than leg pain will be recruited into the study once they have satisfactory pain relief from both low and high frequency stimulations. Each patient will then receive stimulation at four different frequencies for 2-3 weeks in a random and blinded order. Their pain scores and function will be assessed using a variety of different tools. The data will then be used to estimate the optimal frequency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
22
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
North Bristol NHS Trust
Bristol, Avon, United Kingdom
Orsett Hospital
Orsett, Essex, United Kingdom
South Tees NHS Foundation Trust
Middlesbrough, United Kingdom
Back pain relief
Mean reported pain on Numerical Rating Scale (NRS)
Time frame: Three months
Leg pain relief
Mean reported pain on Numerical Rating Scale (NRS)
Time frame: 3-6 months
Patient global impression of change at end of Long-Term Follow-up
Questionnaire
Time frame: 6-9 months
Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up
Questionnaire
Time frame: 6-9 months
Change in activities of Daily Living related to back pain disability from Baseline visit to end of Long-Term Follow-up
Questionnaire
Time frame: 6-9 months
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