PURPOSE: The objective was to assess the effects of therapeutic nuclear magnetic resonance (tNMR) as a conservative treatment for lumbar radicular syndrome (LRS) in patients with lumbar disc herniation. METHODS: The prospective, randomised, double-blind, placebo-controlled trial included 94 patients, aged 20-60 years (44.79 ± 8.83), with LRS caused by lumbar disc herniation confirmed by MRI scans and with clinical signs of a radicular lesion without indication for surgical intervention. Treatment group (TG) and control group (CG) received standard non-surgical therapy. Additionally, the TG had seven sessions with the tNMR device with a magnetic flux density of 2.3 mT and a frequency of 85 kHz; the CG received 7 sham treatments. Outcome parameters were the treatment effect on pain intensity (Visual Analogue Scale-VAS), health-related quality of life (36-item Short Form Health Survey-SF-36), disease-related disability (Roland Morris Disability Questionnaire-RMDQ), pain medication intake, duration of sick leave and morphological changes assessed by MRI scan analysis. RESULTS:VAS scores improved significantly in both groups (p < 0.000). Only in week 4, improvement in the TG significantly surpassed that of the CG (morning pain p = 0.011, evening pain = 0.001). In both groups, SF-36 scores reflected a significant amendment in the physical component score (p < 0.000) and a significant deterioration in the mental component score (p < 0.000). SF-36 scores did not differ significantly between groups. RMDQ showed a significant amelioration in both groups (TG and CG p < 0.000), with a tendency to a superior benefit in the TG (p = 0.083). Patients in the TG recorded significantly fewer days of sick leave in month 3 after treatment (p = 0.026). MRI scan summary scores improved significantly in both groups (L4/5 p < 0.000, L5/S1 p < 0.001) and did not differ significantly between the groups. CONCLUSIONS: This trial was the first to investigate the effects of tNMR as an additional treatment of lumbar disc herniation with LRS. The application of tNMR did not meet MCID criteria. It rendered few statistically significant differences between patient groups. The overall results of this trial make a clinical implementation of tNMR in the treatment of lumbar disc herniation with LRS appear premature. Further research is needed to better understand the mode of action of tNMR on compressed neural tissue and to elucidate the issue of the cost/benefit ratio.
RCT Entities:
PURPOSE: The objective was to assess the effects of therapeutic nuclear magnetic resonance (tNMR) as a conservative treatment for lumbar radicular syndrome (LRS) in patients with lumbar disc herniation. METHODS: The prospective, randomised, double-blind, placebo-controlled trial included 94 patients, aged 20-60 years (44.79 ± 8.83), with LRS caused by lumbar disc herniation confirmed by MRI scans and with clinical signs of a radicular lesion without indication for surgical intervention. Treatment group (TG) and control group (CG) received standard non-surgical therapy. Additionally, the TG had seven sessions with the tNMR device with a magnetic flux density of 2.3 mT and a frequency of 85 kHz; the CG received 7 sham treatments. Outcome parameters were the treatment effect on pain intensity (Visual Analogue Scale-VAS), health-related quality of life (36-item Short Form Health Survey-SF-36), disease-related disability (Roland Morris Disability Questionnaire-RMDQ), pain medication intake, duration of sick leave and morphological changes assessed by MRI scan analysis. RESULTS: VAS scores improved significantly in both groups (p < 0.000). Only in week 4, improvement in the TG significantly surpassed that of the CG (morning pain p = 0.011, evening pain = 0.001). In both groups, SF-36 scores reflected a significant amendment in the physical component score (p < 0.000) and a significant deterioration in the mental component score (p < 0.000). SF-36 scores did not differ significantly between groups. RMDQ showed a significant amelioration in both groups (TG and CG p < 0.000), with a tendency to a superior benefit in the TG (p = 0.083). Patients in the TG recorded significantly fewer days of sick leave in month 3 after treatment (p = 0.026). MRI scan summary scores improved significantly in both groups (L4/5 p < 0.000, L5/S1 p < 0.001) and did not differ significantly between the groups. CONCLUSIONS: This trial was the first to investigate the effects of tNMR as an additional treatment of lumbar disc herniation with LRS. The application of tNMR did not meet MCID criteria. It rendered few statistically significant differences between patient groups. The overall results of this trial make a clinical implementation of tNMR in the treatment of lumbar disc herniation with LRS appear premature. Further research is needed to better understand the mode of action of tNMR on compressed neural tissue and to elucidate the issue of the cost/benefit ratio.
Authors: T Bodamyali; B Bhatt; F J Hughes; V R Winrow; J M Kanczler; B Simon; J Abbott; D R Blake; C R Stevens Journal: Biochem Biophys Res Commun Date: 1998-09-18 Impact factor: 3.575
Authors: D G Borenstein; J W O'Mara; S D Boden; W C Lauerman; A Jacobson; C Platenberg; D Schellinger; S W Wiesel Journal: J Bone Joint Surg Am Date: 2001-09 Impact factor: 5.284