Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study

Alberto Maggiani, Lucio Tremolizzo, Andrea Della Valentina, Laurent Mapelli, Silvia Sosio, Valeria Milano, Manuel Bianchi, Francesco Badi, Carolina Lavazza, Marco Grandini, Giovanni Corna, Paola Prometti, Christian Lunetta, Nilo Riva, Alessandra Ferri, Francesca Lanfranconi, ME&SLA Study #, Alberto Maggiani, Lucio Tremolizzo, Andrea Della Valentina, Laurent Mapelli, Silvia Sosio, Valeria Milano, Manuel Bianchi, Francesco Badi, Carolina Lavazza, Marco Grandini, Giovanni Corna, Paola Prometti, Christian Lunetta, Nilo Riva, Alessandra Ferri, Francesca Lanfranconi, ME&SLA Study #

Abstract

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-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-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.

Keywords: Amyotrophic lateral sclerosis; Feasibility; Osteopathic manual treatment; Pilot trial.

Figures

Fig. (1)
Fig. (1)
Gantt chart of the study. During the first study period (T0-T1), 7 ALS patients received OMT once a week (small white blocks) for the first month and fortnightly during the following 8 weeks (big white blocks); during this period, 7 ALS patients were followed according to usual care (FKT arm, black bar). During the second study period (T1-T2), 10 ALS patients received OMT on a weekly basis.
Fig. (2)
Fig. (2)
(A) Pain severity showed a tendency to decrease over time in ALS patients between T1 and T2 (PSI, pain severity index of the BPI, p=0.05), while (B) interference with daily life activities was unchanged (PII, p=0.13). Two-tailed paired Student’s t-test; mean ± SEM; n=10.
Fig. (3)
Fig. (3)
Goal attainment scale (GAS) in ALS patients undergoing to OMT or FKT during the first period (n=7 for each arm, T0-T1; χ2p=0.12) and for those 10 patients completing the following two months (T1-T2 period).

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Source: PubMed

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