Patient preference with respect to QoL and reduction in opioid-induced constipation (OIC) after treatment with prolonged-release (PR) oxycodone/naloxone compared with previous analgesic therapy [PREFER study].

OBJECTIVE: The aim of this study was to assess patient preference in terms of quality of life (QoL), analgesia and bowel function for patients with moderate to severe chronic non-malignant pain, when treated with oxycodone PR/naloxone PR compared with the previous WHO-step I and/or WHO-step II analgesic treatment . STUDY DESIGN: This was a 3-week open-label phase 3b study conducted in Belgium and the Netherlands, after 3 weeks patients could enter an extension phase. Patient preference with respect to QoL for oxycodone PR/naloxone PR treatment compared with previous WHO-step I and/or WHO-step II analgesics was assessed. A patient was considered a responder with respect to QoL if this assessment was 'better' or 'much better' compared with previous WHO-step I or II analgesics at any time point. RESULTS: Response rate with respect to QoL was 59.2% (95% CI: 51.7-66.8%) for the Full Analysis (FA)-population, for the Per Protocol-population response rate was 71.7% (95% CI: 63.1-80.3%). Explorative analysis showed that response rate with respect to QoL was highest in constipated patients pretreated with WHO-step II analgesics (73.8%). Mean ± SD pain score in the FA-population at start was 74.7 ± 16.6 decreasing to 53.9 ± 24.3 after a median (range) treatment period of 173.5 (31-771) days. For constipated subjects the significant reduction in constipation [improvement of the Bowel Function Index (BFI)], was -24.8 points (95% CI: -17.1 to -32.5). BFI for non-constipated subjects remained well below 28.8. Adverse events with oxycodone PR/naloxone PR treatment were well-known opioid-related adverse events. CONCLUSION: This study shows that the studied patients previously treated with WHO-step I and/or WHO-step II analgesics prefer treatment with oxycodone PR/naloxone PR with respect to QoL. Moreover, the study shows that treatment with oxycodone PR/naloxone PR significantly reduces OIC in constipated patients and that non-constipated patients do not develop OIC during treatment with oxycodone PR/naloxone PR.

Percutaneous pulsed radiofrequency treatment of the cervical dorsal root ganglion in the treatment of chronic cervical pain syndromes: a clinical audit.

Cervicogenic headache and cervicobrachialgia are frequent diagnoses of chronic cervical pain. After failure of conservative treatment, an interventional approach may be indicated in the absence of any indication for causal surgical treatment. The pulsed radiofrequency (PRF) technique exposes the nerve to a high-frequency electric field while the temperature of the electrode tip does not exceed 42°C. This method is thought to be nondestructive and almost free of neurologic side effects and complications. Our extended pilot study was performed to confirm the perceived efficacy of PRF for short- and long-term relief of chronic cervical pain. We carried out a clinical audit of the first 18 patients treated with PRF at the cervical dorsal root ganglion. An independent evaluator reviewed the medical records. Patients with good clinical results at 8 weeks were evaluated for long-term effect (> 6 months), based on a 7-point Likert scale. Thirteen patients (72%) showed short-term clinical success (≥ 50% pain relief). Mean follow-up was 19.4 months (SD 8.9 months), maximum 2.5 years. The duration of satisfactory pain relief (6 or 7 on the Likert scale) varied between 2 and over 30 months, with a mean duration of 9.2 months (SD 11.2 months). Kaplan-Meier analysis illustrated that 50% of patients experienced success 3 months after treatment. We could not identify predictive variables for clinical outcome. None of the patients reported post-treatment neuritis or other adverse events. To our knowledge, this is the first documented series of chronic cervical pain syndromes treated with PRF. Satisfactory pain relief of at least 50% was achieved in 13 of 18 (72%) patients at 8 weeks. More than one year after treatment, six patients (33%) continue to rate treatment outcome as good or very good. No side effects were reported. j.

Application of radiofrequency treatment in practical pain management: state of the art.

Many therapeutic interventions for chronic pain are available, and decisions about optimal management are not easy to make. Radiofrequency (RF) treatment is classified as a percutaneous minimal invasive procedure for patients who do not respond to appropriate medical and physical therapy. Although RF treatment is widely used differences in current practice exist due to ongoing controversies.

Efficacy of spinal cord stimulation: 10 years of experience in a pain centre in Belgium.

Spinal cord stimulation is a minimally invasive mode of treatment in the management of certain forms of chronic pain that do not respond to conventional pain therapy. Several authors have reported encouraging findings with this technique. Over a 10-year period in a single centre, 254 patients were subjected to a trial period of spinal cord stimulation with an externalized pulse generator. Two hundred and seventeen of the patients showed satisfactory results justifying permanent implantation of a spinal cord stimulation system. In 1998, an independent physician invited 153 patients (155 pain cases), who still had the system in place and who could be contacted, for an interview. The aim of this study was to evaluate the efficacy of an implanted spinal cord stimulation system in terms of pain relief and quality of life and to assess the accuracy of the patient selection criteria. The results of this study demonstrate a high success rate as evaluated by the patients' own assessments--68% of the patients rated the result of the treatment as excellent to good after an average follow-up of almost 4 years. The resumption of work by 31% of patients who had been working before the onset of pain supports these positive findings.

Treatment of failed back surgery syndrome patients with low back and leg pain: a pilot study of a new dual lead spinal cord stimulation system.

Objective. Treatment of pain associated with failed back surgery syndrome was evaluated in a pilot clinical study of a new dual lead spinal cord stimulation (SCS) system. Methods. The following data was retrospectively sought from 20 non-randomized patients at 2 centers treated by the new SCS system, instead of an implantable drug pump: 1) prior back surgeries, 2) pain and paresthesia mapping, 3) VAS ratings, 4) medication use, 5) sleep patterns, 6) physical abilities, 7) hardware problems, and 8) willingness to repeat the procedure. Two-year follow-up was sought from all patients. Results. The new dual lead SCS system provided good low back and leg paresthesia coverage. Patients reported having less pain and using fewer analgesics and narcotics during follow-up, compared to their preimplant experience. These improvements were statistically significant. Patients also improved their sleep and physical abilities during follow-up. While external hardware problems occurred, 65% of dual lead SCS patients were willing to repeat the SCS implant procedure. Conclusions. Dual lead stimulation proved beneficial for patients with low back and leg pain associated with failed back surgery syndrome.

Intrathecal labor analgesia: can we use the same mixture as is used epidurally?

In a randomized double-blind study, three groups of 25 term parturients received one of the following intrathecal drugs or combinations for relief of labor pain: sufentanil 7.5 microg (1.5 ml), sufentanil 5 microg + bupivacaine 1 mg (1.5 ml) or the combination bupivacaine 1.75 mg, sufentanil 1.05 microg and epinephrine 1.75 microg, that is 1.5 ml of our standard epidural mixture. After the intrathecal injection, patients received a peridural catheter for supplementation of analgesia. Onset and duration of the three regimens were similar. Analgesia lasted for approximately 95-115 minutes which was similar to durations obtained with the subsequent epidural top-ups. Pruritus was observed significantly less frequently in the group treated intrathecally with the epidural mixture. The incidence of other maternal side-effects was extremely low and not different among the groups. Instrumental delivery, Apgar scores and umbilical blood gases were identical. More cardiotocographic changes were observed in the plain sufentanil group but this was not related to neonatal outcome. It was concluded that intrathecal injection of the standard epidural mixture offers effective and long-lasting analgesia. This may avoid side-effects and complications, manipulations of drugs with the risk for contamination, spilling of drugs and loss of time.