The effect of spinal cord stimulation on weekly step count of patients with back and leg pain
Dr Murray Taverner
40 participants
May 29, 2015
Observational
Conditions
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
Inclusion Criteria6
- Patients with chronic, intractable back pain, with or without radicular symptoms to one or both legs (with or without prior back surgery) indicated for spinal cord stimulation trial (post spine surgery, neuropathic pain)
- Is a new or existing patient of Frankston Pain Management, Frankston Hospital pain medicine or PainCare clinics
- Has chronic, intractable pain
- Appropriate clinical diagnosis
- Positive psychological evaluation
- No pending lawsuit or economic compensation related to the pain
Exclusion Criteria11
- patients who are contraindicated from receiving a spinal cord stimulator,
- are likely to be non-compliant or
- don’t want to participate.
- Specific criteria for exclusion include:
- Patients for dorsal root ganglion stimulation
- Patients having full system implanted without prior period of trial stimulation
- Inability to give informed consent,
- Inability to understand English (most pain assessment tools are validated for English language speakers only),
- Contraindicated for spinal cord stimulation; i.e.: are unable to operate the SCS system, are poor surgical risks, are pregnant
- Non-compliance with stimulator usage and/or stimulation parameter settings
- Unable to wear activity monitor on wrist
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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)
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ACTRN12615000254594