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A randomised controlled trial on the efficacy of hydroelectrophoresis in acute recurrences in chronic low back pain patients
Brizzi A, Giusti A, Giacchetti P, Stefanelli S, Provinciali L, Ceravolo MG
Europa Medicophysica [Mediterranean Journal of Physical and Rehabilitation Medicine] 2004 Dec;40(4):303-309
clinical trial
9/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: Yes; 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*

AIM: Physical therapy efficacy in the treatment of low back pain (LBP) has been widely debated and is far from achieving high levels of evidence. Hydroelectrophoresis (Hydrofor) is a novel method of driving drugs through the dermal tissue, which has been proposed for muscle pain treatment. Aim of this randomised placebo-controlled study was to ascertain the efficacy of Hydrofor treatment on acute relapsing episodes of pain in chronic LBP subjects. METHODS: Eighteen under-50 adults (M/F 7/11; age 35 +/- 8 years) suffering from chronic LBP were enrolled within 3 to 4 days of back pain relapse. After a complete clinical and functional assessment patients were randomly divided into 2 equal groups. Group A received 3 Hydrofor applications of a mixture containing both NSAIDs and muscle relaxants, whereas group B received 3 Hydrofor applications of a drug-free solution. Afterwards, both groups performed the same rehabilitation treatment consisting of 7 group sessions of standard physiotherapy, including stretching, range of motion and extension exercises. The Oswestry disability index (ODI), the Million instrument scale and a visual analogue scale (VAS) were chosen as outcome measures and applied at baseline, after Hydrofor/placebo applications, after completion of rehabilitation sessions and, at last, 2 months later. The two-way Friedman test was used to analyse within-group (time effect) and between-group (time x group effect) differences. RESULTS: All subjects declared a significant pain reduction since the first Hydrofor application. Pain evolution overlapped in the 2 groups until the 3rd session, after which group A significantly diverged from group B, as they affirmed a greater symptom reduction than controls (time x group effect: VAS: F = 7.4, p < 0.01). Such difference disappeared after the physiotherapy sessions as well as 2 months later (time x group effect: VAS: F = 2.1, p = 0.08). Pain-related disability showed a greater reduction in group A than B immediately after Hydrofor application (time x group effect: ODI: F = 3.9, p < 0.05; Million: F = 4.1, p < 0.05), but the mean scores almost overlapped at the 2 month follow-up (time x group effect: ODI: F = 2.3, p = 0.08; Million: F = 1.3, p = 0.26). CONCLUSIONS: Hydrofor treatment relieves relapsing LBP and could be recommended to active adults as a safe technique shortening the time needed to achieve functional restoration.

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