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Effect of pulsed magnetic field therapy on the level of fatigue in patients with multiple sclerosis -- a randomized controlled trial |
Mostert S, Kesselring J |
Multiple Sclerosis 2005 Jun;11(3):302-305 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: No; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
Twenty-five multiple sclerosis patients, taking part in a rehabilitation program, were randomly assigned to treatment with pulsed magnetic field therapy (PMFT) or to sham therapy in order to study the additional effect of PMFT as part of a multimodal neurological rehabilitation program on fatigue. Patients demographic and disease specific characteristics were recorded. Level of fatigue was measured by fatigue sverity scale (FSS) at entrance and discharge and with a visual analog scale (VAS) immediate before and after a single treatment session. The 'Magnetic Cell Regeneration' system by Santerra was used for PMFT. A single treatment lasted 16 minutes twice daily over 3 to 4 weeks and consisted of relaxed lying on a PMF mattress. Sham intervention was conducted in an identical manner with the PMF-device off. Patients and statistics were blinded. Level of fatigue measured by FSS was high at entrance in both treatment group (TG) and controlgroup (CG) (5.6 versus 5.5). Over time of rehabilitation fatigue was reduced by 18% in TG and 7% in CG which was statistically not significant. There was a statistically significant immediate effect of the single treatment session witch 18% reduction of fatigue measured by VAS in TG versus 11% in CG. Because of a high 'placebo effect' of simple bed rest, a only small and short lasting additional effect of PMFT and high costs of a PMF-device, we cannot recommend PMFT as an additional feature of a multimodal neurological rehabilitation program in order to reduce fatigue level of MS-patients.
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