ObjectivesThis study aimed to investigate the hypothalamic-pituitary-gonadal axis in a sample of male patients undertaking intrathecal opioid delivery for the management of chronic non-malignant pain and the presence of osteopaenia and/or osteoporosis in those diagnosed with hypogonadism.DesignObservational study using health data routinely collected for non-research purposes.SettingDepartment of Pain Management, Russells Hall Hospital, Dudley, UK.PatientsTwenty consecutive male patients attending follow-up clinics for intrathecal opioid therapy had the gonadal axis evaluated by measuring their serum luteinising hormone, follicle stimulating hormone, total testosterone, sex hormone binding globulin and calculating the free testosterone level. Bone mineral density was measured by DEXA scanning in those patients diagnosed with hypogonadism.ResultsBased on the calculated free testosterone concentrations, 17 (85%) patients had biochemical hypogonadism with 15 patients (75%) having free testosterone <180 pmol/L and 2 patients (10%) between 180 and 250 pmol/L. Bone mineral density was assessed in 14 of the 17 patients after the exclusion of 3 patients. Osteoporosis (defined as a T score ≤−2.5 SD) was detected in three patients (21.4%) and osteopaenia (defined as a T score between −1.0 and −2.5 SD) was observed in seven patients (50%). Five of the 14 patients (35.7%) were at or above the intervention threshold for hip fracture.ConclusionsThis study suggests an association between hypogonadism and low bone mass density in patients undertaking intrathecal opioid delivery for the management of chronic non-malignant pain. Surveillance of hypogonadism and the bone mineral density levels followed by appropriate treatment may be of paramount importance to reduce the risk of osteoporosis development and prevention of fractures in this group of patients.
PENS therapy appears to be effective in providing short-term pain relief in chronic pain conditions. Studies, involving larger sample sizes and longer follow-up are recommended.
This study, with one of the longest follow-up intervals reported in the IDDS literature, shows that IDDS has the potential to be a life-long pain management solution in appropriately selected patients with chronic nonmalignant pain.
ObjectiveThis study aimed to investigate the efficacy of intrathecal morphine in the long term by hypothesising that a reduction of the intrathecal opioid dose following long-term administration would increase the level of pain intensity.DesignRandomised, double-blind, controlled, parallel group trial.SettingDepartment of Pain Management, Russells Hall Hospital, Dudley, UK.Participants24 patients with non-cancer pain implanted with morphine reservoirs were assessed for eligibility.InterventionsParticipants were randomly allocated to one of two parallel groups in which one of the groups had no change in morphine dose and the other group had a small reduction (20%) in dosage every week during a 10-week follow-up.OutcomePrimary outcomes were visual analogue scale (VAS) pain score change and withdrawal from the study due to lack of efficacy.Results9 of the patients assessed for eligibility declined to participate in the study. 15 patients were randomised to control (n=5) or intervention (n=10) and included in an intention-to-treat analysis. Owing to worsening of pain, seven patients withdrew from the study prematurely. None knew prior to withdrawal which arm of the study they were in, but all turned out to be in the dose-reduction arm. The calculation of dropout rates between groups indicated a significant statistical difference (p=0.026) and recruitment was ceased. The VAS change between baseline and the last observation was smaller in the control group (median, Mdn=11) than in the intervention group (Mdn=30.5), although not statistically significant, Z=−1.839, p=0.070; r=−0.47. Within groups, VAS was significantly lower at baseline (Mdn=49.5) than at the last observation (Mdn=77.5) for the reduction group, Z=−2.805, p=0.002; r=−0.627 but not for the control group (p=0.188).ConclusionsThis double-blind randomised controlled trial of chronic intrathecal morphine administration suggests the effectiveness of this therapy for the management of chronic non-cancer pain. However, owing to the small number of patients completing the study (n=8), further studies are warranted.Trial registrationInternational Standard Randomised Controlled Trials Centre (ISRCTN 33733462).
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