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Osteopathic manual treatment for amyotrophic lateral sclerosis: a feasibility pilot study
Maggiani A, Tremolizzo L, Valentina AD, Mapelli L, Sosio S, Milano V, Bianchi M, Badi F, Lavazza C, Grandini M, Corna G, Prometti P, Lunetta C, Riva N, Ferri A, Lanfranconi F, for the ME&SLA Study
The Open Neurology Journal 2016 Aug 26;10:59-66
clinical trial
3/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Current interventions in amyotrophic lateral sclerosis (ALS) are focused on supporting quality of life (QoL) and easing pain with a multidisciplinary approach. OBJECTIVE: Primary aim of this pilot work assessed feasibility, safety, tolerability and satisfaction of osteopathic manual treatment (OMT) in 14 ALS outpatients. METHODS: Patients were randomized according to an initial single-blind design (12 weeks, T0 to T1), in order to receive OMT (weekly for 4 weeks, and fortnightly for the following 8 weeks) versus usual-care (n = 7 each group), followed by an OMT open period (T1 to T2, once a week for 8 weeks, n = 10). Secondary aims included blind osteopathic assessment of somatic dysfunctions (SD) for goal attainment scale (GAS) calculation, Brief Pain Inventory-short form and McGill QoL-16 items. RESULTS: OMT was demonstrated feasible and safe and patients displayed high satisfaction (T1-VAS 8.34 +/- 0.46; T2-VAS 8.52 +/- 0.60). Considering secondary aims no significant differences emerged. Finally, at study entry (T0), a cervico-dorsal SD was found in 78% of ALS patients versus 28% of healthy matched controls (p < 0.01). CONCLUSION: OMT was found feasible, safe and satisfactory in ALS. The lack of secondary aim differences can be due to the limited sample size. OMT could be an interesting option to explore in ALS.

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