RecruitingACTRN12615000254594

The effect of spinal cord stimulation on weekly step count of patients with back and leg pain

Sponsor

Dr Murray Taverner

Enrollment

40 participants

Start Date

May 29, 2015

Study Type

Observational

Conditions

Back and leg pain

Summary

General activity level in patients being considered for spinal stimulation and the improvement in activity levels after stimulator insertion have not been documented and both are unknown. In this study physical activity measurements, as measured by the Garmin Vivofit device, will be compared to usual questionnaires that you complete for assessment of pain, pain relief and functional improvement before and after the insertion of spinal cord stimulator leads. This study involves wearing a wrist band (Vivofit, Garmin Ltd) for 2 weeks before and 1-2 weeks after the insertion of the spinal cord stimulator lead. The primary endpoint will be comparing Vivofit baseline (pre institution of neurostimulation therapy) total step count for 1 week prior to lead insertion to weekly total step count in the last week of the trial of stimulation. Secondary endpoints will compare Vivofit baseline step counts to self-report questionnaires (BPI, Dass21, ESS, PCS, PSEQ, SF36, OSW), TUG, 6MWT, in addition to medication usage at the same time points.

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is looking at how much a spinal cord stimulator — a device implanted to manage chronic back and leg pain — improves a patient's ability to move around and be physically active. Researchers will measure daily step count using a wrist activity tracker (the Garmin Vivofit) both before and after the stimulator is trialled, and compare this to standard pain and quality-of-life questionnaires. You may be eligible if: - You have chronic, difficult-to-treat back pain, with or without leg pain, and have been recommended for a spinal cord stimulation trial - You are a patient of a participating pain clinic (Frankston Pain Management, Frankston Hospital pain medicine, or PainCare) - You have had an appropriate clinical assessment and psychological evaluation - You have no ongoing lawsuit or financial compensation claim related to your pain You may NOT be eligible if: - You are being considered for dorsal root ganglion stimulation specifically - You are having the full system implanted without a trial period - You are unable to give informed consent - You cannot understand English (the pain assessment tools require English) - You are pregnant - You are unable to operate the stimulator system - You are unable to wear an activity monitor on your wrist Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Spinal cord stimulation (SCS) is used to treat patients with long term nerve pain by applying an electrical current to the spinal cord or peripheral nerves. This is done via small metal contacts called electrodes which are fixed to a cable called a lead. When a pain specialist wants to use a spinal cord stimulator in a patient, the patient has a surgical operation to put one or more leads into the body. These leads are then connected to an external battery which is worn by a patient using a belt. After a “trial” period lasting 1-2 weeks, the effectiveness of the stimulation is assessed and if the ‘trial’ deemed successful a permanent system is implanted. The stimulators will be programmed by company technicians as per manufacturer guidelines. Participants will wear a Vivofit (Garmin Ltd) fitness band for 2 weeks before and 1-2 weeks after insertion of the spinal cord stimulator leads. Patient data from the Vivofit monitor, walking tests and questionnaire responses will be collected during the routine twice weekly outpatient clinic visits used to monitor the clinical progress of the ‘trial’ of stimulation.

Locations(3)

Frankston Hospital - Frankston

WA,VIC, Australia

Beleura Private Hospital - Mornington

WA,VIC, Australia

Bethesda Hospital - Claremont

WA,VIC, Australia

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ACTRN12615000254594