[Mild whole body hyperthermia in combination with inpatient multimodal oriented pain therapy: evaluation in patients with chronic unspecific lumbar back pain].

PURPOSE: A randomized controlled clinical trial was implemented to evaluate the effectiveness of combined mild hyperthermia therapy (body core temperature 38.4 °C) and multimodal inpatient rehabilitation for patients suffering from chronic low back pain when compared to multimodal pain therapy alone. PATIENTS AND METHODS: A total of 88 patients were randomly assigned to the combined or single therapeutic schemes according to a block randomization scheme. According to the trial inclusion criteria all patients suffered from chronic low back pain and showed morphological degeneration. All patients underwent a 12-day inpatient multimodal pain therapy, which was complemented with a 6-session schedule of mild hyperthermia therapy for the intervention group (1 h at 38.6 °C). On admission and 3 months after treatment the study patients were asked to complete an interview assessment with the Oswestry low back pain disability questionnaire (Oswestry disability index). The change in the Oswestry disability index total score (%) 3 months after versus before therapy was defined as the primary clinical endpoint of the investigation. The patients in the control group and in the intervention group had a median age of 50 years. In the intervention group 70 % of the patients were female and 55 % reported having half to full time employment compared to 55 % and 43 % in the control group, respectively.
RESULTS: On admission the control patients reported a median Oswestry disability index of 64 % and on recall the same of 64 %. The intervention group showed median Oswestry disability index estimates of 60 % and 66 %, respectively. The changes in the overall Oswestry disability index after 3 months differed significantly with an estimated 6 % for the intervention group versus 0 % for the control group (Wilcoxon p = 0.050).
CONCLUSION: When combined with a multimodal inpatient lower back pain functional therapy in patients showing morphological degeneration, the mild hyperthermia therapy demonstrated statistically significant, although not clinically relevant benefits in comparison to the multimodal treatment alone. However, regarding the moderate overall patient-related benefits as measured in terms of the Oswestry disability index, the benefit of the underlying multimodal therapy concept implementation must be critically discussed irrespective of its combination with mild hyperthermia therapy.

RCT Entities:   Population Interventions Outcomes