A study investigating movement, pain and activity in failed back surgery patients undergoing spinal cord stimulation.
An Investigator initiated prospective partially blinded study assessing movement, pain and activity in participants undergoing neuro-modulation trials and implantation for failed back surgery syndrome.
Dr Richard Sullivan
25 participants
Aug 6, 2015
Interventional
Conditions
Summary
Spinal cord stimulation (SCS) is a treatment option for cases of persistent pain, refractory to other forms of treatment. The first wave of studies produced generally favourable results, with reductions in pain ranging from 49% (Alo, Redko & Charnov, 2002), 55% (Villavicencio et al., 2000) to 74% (Dario et al., 2001). Since this time, a systematic review of 63 publications, predominantly comprised of case series, found that 58% of patients achieved clinically meaningful pain relief at two year follow up (Taylor et al., 2014). Taking this finding at face-value, it appears approximately 42% of chronic pain patients under-going SCS do not achieve significant pain relief. However, among this population, there is presently a scarcity of research to examine change to mobility and function. This is important, as it is plausible that the analgesic effects of SCS could be mitigated by patients increasing their mobility; a clinically important outcome in and of itself. To the author’s knowledge, objective measures of movement pre and post SCS have not been reported in the literature. Thus, the key aim of the present clinical trial is to objectively assess change to motion and mobility in patients with persistent pain following SCS, and its relationship to change in pain levels. On this basis, the following hypotheses were generated: 1. Movement and pain will correlate in participants with FBSS undergoing SCS trial and implantation 2. Activity and the ODI index will correlate in participants with FBSS undergoing SCS trial and implantation.
Eligibility
Inclusion Criteria7
- Males and Females aged over 18
- FBSS, defined as persistent or re-current low back and leg pain of at least 6 months duration, following at least one decompression and/or fusion procedure
- Deemed as clinically appropriate for a trial of spinal cord stimulation for the treatment of FBSS
- Minimum average pain level measured on a numerical rating scale of at least 3
- Activity limitation as recorded by the Oswestry disability index of > 20%
- Pain that changes with position or movement
- Ability to understand and willingness to sign an informed consent statement in English
Exclusion Criteria10
- Lower back surgery within previous six months.
- The subject is being currently treated or has been treated with SCS, subcutaneous or peripheral nerve stimulation, intrathecal drug delivery system, or is awaiting further lumbar surgery.
- Is pregnant or planning to become pregnant during the course of the study;
- Subjects with a severe hearing impairment or inability to follow verbal instructions.
- Evidence of non-mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder or persistent non-fluctuating pain.
- Implanted electrical medical device that would conflict with either the spinal cord stimulator implant or the measurement technology
- Significant medical or psychological abnormalities/conditions, a history of substance abuse or recent history of a medical-surgical intervention that in the opinion of the investigator would interfere either with the ability to complete the study or the assessments.
- Known allergy skin reaction to tapes and plasters.
- Subject who is currently enrolled in an investigational drug or device study
- Inability to operate the SCS equipment, comply with study requirements or complete questionnaires in English independently.
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Interventions
Undertake a preliminary investigation of pain, movement and activity in subjects undergoing SCS trial and implantation that will provide useful insights for the development of a larger randomised controlled study. ViMove wearable sensors will be worn by all subjects on their lower back. Spinal cord stimulation delivers mild electrical impulses to the spinal cord that interrupt pain signals to the brain, replacing them with a tingling sensation. The stimulation to the spinal cord is delivered from the device through insulated wires called leads, which are placed adjacent to the spinal cord. Using a handheld device that works like a remote control, the stimulator can be adjusted to specific areas and levels of pain, depending on activities and pain levels during the day. SCS trial is when the leads are temporarily placed via needles to test the effectiveness of the device. This is an outpatient procedure, where the implant is tested for approximately one week at home in normal surroundings. SCS implantation involves surgery where a small incision in the back is needed to allow the leads to be placed underneath the skin, and another small incision is needed for the stimulator to be implanted permanently under the skin, usually in the buttocks or abdominal area. ViMove are wearable sensors that measure movement and muscle activity. It is easily worn on the lower back through attaching with adhesives and can be worn throughout the day to objectively record and report to the clinician on a patient's movement and function. It will be worn in clinic for a short assessment and then for the rest of the day before SCS trial, during SCS trial and for those that go onto implantation will again be measured at 3 specific time points (4, 12 & 26 weeks) post the implantation to clearly track how SCS impacts on movement and function.
Locations(1)
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ACTRN12615001038583