The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial

Abstract

Background

Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

Methods

Interventional study (not related to a health product), monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21. On D0 subjects will be randomized in 2 groups: experimental and placebo group. Both groups will be assessed on: Short Physical Performance Battery test score, walking speed, lower limb strength, balance, heart rate variability and cervical spine strength and mobility. Then the experimental group will receive a myofascial release protocol applied to the cervical spine and the placebo group will receive a placebo light touch protocol. The intervention will be followed by the same measurements as before. This schedule will be reproduced on D7. On D21, only one assessment will be done.

Discussion

This study started in 2020 but could not go beyond the inclusion phase due to the COVID pandemic. It is envisaged that recruitment could resume during 2022.

Trial registration: Registered by the Comité de Protection des Personnes—Sud Méditerranée; under the title “Prévention des troubles de l’équilibre chez le senior: influence de la thérapie manuelle appliquée au rachis sur les paramètres statiques et dynamiques», n° 19.12.27.47.259 in date of February 4, 2020.

Registered by ClinicalTrials.gov ID: NCT05475652; under the title « The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly (ManEq)”.