Higher Pain Sensitivity Predicts Efficacy of a Wearable Transcutaneous Electrical Nerve Stimulation Device for Persons With Fibromyalgia: A Randomized Double-Blind Sham-Controlled Trial.

OBJECTIVES: This study investigated the efficacy of a transcutaneous electrical nerve stimulation (TENS) device (Quell®) for persons with symptoms due to fibromyalgia (FM). MATERIALS AND METHODS: One hundred nineteen (N = 119) subjects were randomly assigned to use an active (N = 62) or sham (N = 57) TENS for three months. All subjects completed baseline questionnaires and were administered quantitative sensory testing (QST). Subjects completed the Patients' Global Impression of Change (PGIC, primary outcome measure) and other mailed questionnaires (secondary outcome measures) at six weeks and three months. RESULTS: The subjects averaged 50.4 ± 13.5 years of age, 93.3% were female, and 79.8% were Caucasian. Most showed benefit from using the TENS, but no differences between groups were found on the primary outcome measure after three months (active 3.87 ± 1.85, sham 3.73 ± 1.80, 95% confidence interval [CI] [-0.60, 0.88], p = 0.707). Those with more hypersensitivity showed most improvement on the PGIC at six weeks (0.22, 95% CI [0.01, 0.43], p = 0.042) and three months (0.20, 95% CI [0.00, 0.41], p = 0.049) and among those with higher sensitivity based on QST, the active TENS group showed the most benefit with TENS compared with the sham treatment (1.20, 95% CI [0.22, 2.18], p = 0.017). No TENS-related serious adverse events were reported. Subjects in the sham group correctly identified their treatment 87.5% of the time, while, surprisingly, subjects in the active group correctly identified their treatment only 17.4% of the time. CONCLUSION: This study found no differences between those who were exposed to maximal-frequency active stimulation or minimal-frequency sham stimulation from a wearable TENS in reducing FM-related symptoms. However, those with greater hypersensitivity showed most benefit from TENS. Additional studies to help determine the role individual differences play in the use of TENS in managing FM-related symptoms are needed.

Spinal cord stimulation in a patient with spinal epidural lipomatosis.

BACKGROUND AND OBJECTIVE: Spinal cord stimulation is the most commonly used implantable neurostimulation modality for management of pain syndromes. For treatment of lower extremity pain, the spinal cord stimulator lead is typically placed in the thoracic epidural space, at the T10-T12 levels. Typically, satisfactory stimulation can be obtained relatively easily. Anatomical variability in the epidural space, such as epidural scarring, has been reported to prevent successful implantation of spinal cord stimulators. Spinal epidural lipomatosis describes an abnormal overgrowth of adipose tissue in the extradural space. Cases have documented spinal epidural lipomatosis complicating intrathecal baclofen pump implantation or causing repeated failure of epidural analgesia. However, so far, there is no published literature describing how spinal epidural lipomatosis affects spinal cord stimulation. CASE REPORT: We report a case of spinal cord stimulation in a patient with spinal epidural lipomatosis. Very high impedance was encountered during the trial spinal cord stimulator lead placement. Satisfactory stimulation was only obtained after repeated repositioning of the spinal cord stimulator trial lead. Post-procedure thoracic spine magnetic resonance imaging revealed marked thoracic epidural lipomatosis. At the level where satisfactory stimulation was obtained, the thickness of the epidural fat was within normal limits. The patient eventually underwent placement of a laminotomy lead with good coverage and pain relief. CONCLUSION: Spinal epidural lipomatosis significantly increases the impedance in the epidural space, making effective neurostimulation very difficult to obtain. Physicians should consider the possibility of spinal epidural lipomatosis when very high impedances are encountered during lead placement.