The international no-profit organization Cochrane, that takes care of critically evaluating and spreading information about the efficiency and safety of health interventions, has considered MANU®, the hand brace against carpal tunnel syndrome, a conservative treatment of proved efficiency and tolerability (O’Connor et al. – Cochrane Database System Rev. 2003).
MANU® has been reported as a conservative treatment for carpal tunnel syndrome on the guidelines of the AAFP (American Academy of Family Physician), and has also been approved by FDA (USA Food and Drug Administration) among the medical devices with proven safety and efficiency with registration number 3002654235.
The effectiveness and tolerability of MANU® has been scientifically proven on rigorous studies published on the international medical literature surveyed in the database of the international biomedical disciplines MEDLINE (Medical Literature Analysis and Retrieval System Online) of National Institute of Health (NIH), in which it refers to MANU® and there are some abstracts taken from the search engine for scientific literature PubMed.
Muscle Nerve. 1999 Nov;22(11):1587-9.
A relief maneuver in carpal tunnel syndrome.
Manente G, Torrieri F, Pineto F, Uncini A.
We describe a maneuver that eases or abolishes paresthesias in carpal tunnel syndrome. With the affected hand palm up, the distal metacarpal heads are gently squeezed together; in some instances stretch of digits III and IV is also required. This maneuver may help in the clinical diagnosis of carpal tunnel syndrome, can be useful as a means of relieving symptoms, and provides the basis for the design of an innovative splint.
Muscle Nerve. 2001 Aug;24(8):1020-5.
An innovative hand brace for carpal tunnel syndrome: a randomized controlled trial.
Manente G, Torrieri F, Di Blasio F, Staniscia T, Romano F, Uncini A.
We developed a hand brace and studied its efficacy and tolerability in patients with carpal tunnel syndrome (CTS). We randomized 83 subjects into a treated group, which wore the hand brace at night for 4 weeks, and a control group, which received no treatment. The primary efficacy measure was change in the Boston Carpal Tunnel Questionnaire (BCTQ) score. Secondary measures were Subjects’ Global Impression of Change Questionnaire (SGICQ), median distal motor latency, sensory conduction velocity and amplitude, and neurophysiological class of severity. The treated group showed a reduction in BCTQ symptomatic score (from 2.75 to 1.54 at 4 weeks; P < 0.001) and functional score (from 1.89 to 1.48; P < 0.001). There were no significant changes in the control subjects. SGICQ documented improvement in all treated subjects (P = 0.006). No significant difference was found in electrophysiological measurements, but overall neurophysiological classification shifted to less severe classes in the treated group (P < 0.05). Thus, the study demonstrates that this hand brace is highly efficient in relieving symptoms and functional loss in CTS.
Acta Neurol Scand. 2009 Jan;119(1):68-74. doi: 10.1111/j.1600-0404.2008.01072.x. Epub 2008 Jul 13.
Efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome: a randomized controlled study.
De Angelis MV, Pierfelice F, Di Giovanni P, Staniscia T, Uncini A.
OBJECTIVE: To examine, in a randomized, controlled, single blinded trial, the efficacy of a soft hand brace and a wrist splint for carpal tunnel syndrome (CTS).
METHODS: We randomized 120 patients with CTS into a group wearing the soft hand brace MANU and into another group wearing the wrist splint CAMP TIELLE at night for 3 months. We re-evaluated the patients after 3 (T1) and 9 months (T2). The primary efficacy measures were changes in scores of Boston Carpal Tunnel Questionnaire (BCTQ) and in Visual Analogical Scale (VAS) for pain and paresthesias.
RESULTS: At T1, both groups showed a significant reduction in symptomatic and functional BCTQ (T0-T1 differences: MANU BCTQ sympt: 0.88 (0.68-1.08), funct: 0.45 (0.19-0.72); TIELLE BCTQ sympt: 0.78 (0.55-1.01), funct: 0.41 (0.22-0.59). At T2, a less evident benefit on symptoms persisted in both groups, except for pain VAS score that was significantly reduced only in the CAMP TIELLE group. No significant functional benefits persisted in either group. There were no differences in BCTQ and VAS scores between the two groups at T1 and T2 compared with that at baseline.
CONCLUSIONS: A 3-month treatment with either the hand brace or the wrist splint induces a symptomatic and functional benefit in patients with CTS.
J Hand Surg Eur Vol. 2013 Jan;38(1):57-60. doi: 10.1177/1753193412446112. Epub 2012 May 28.
Changes in the carpal tunnel while wearing the Manu® soft hand brace: a sonographic study.
Manente G, Melchionda D, Staniscia T, D’Archivio C, Mazzone V, Macarini L.
We studied the effect of the MANU® soft hand brace, which has been designed to relieve median nerve entrapment in carpal tunnel syndrome. An observational, controlled study was conducted in 10 participants, five with bilateral carpal tunnel syndrome and five controls, using sonography to study changes in the dimensions of the carpal tunnel before and while wearing the brace. An increase in transverse diameter, thinning of the flexor retinaculum, and displacement of the proximal insertion of the lumbrical muscle to the middle finger from the edge of the carpal tunnel were observed in patients while wearing the brace. The changes in the morphology of the carpal tunnel while wearing the MANU® support its use as an alternative to a night wrist splint.