Clinical trial NCT03169218: Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom
Official title: Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Adult
Chronic pain
Entrapment neuropathy. Carpal tunnel
Exercise therapy
Humans
Neuronal plasticity
Mirror neurons
Pain/cognitive aspects
Physiotherapy
Somatosensory cortex
Lead sponsor: Hospital de Manises
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
name: University Rovira i Virgili
First posted: 2017-05-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate pain and function after mirror therapy as well as level of catastrophism in bilateral carpal tunnel syndrome patients

Detailed description: The sample calculation was performed based on the previous pilot study, in which 10 subjects were included. Through this study, a statistically significant effect on the variables analyzed was demonstrated. Therefore, it was determined to duplicate the initial sample to confirm the effect previously studied, assuming losses of 20%. Thus, the value of n for the clinical trial is 20 subjects.

Eligibility criteria: Inclusion Criteria:

* Must be signed the informed consent.
* Bilateral carpal tunnel syndrome: clinic and electromiography positive.
* Aged between 18 and 65 years

Exclusion Criteria:

* Patients undergoing surgical intervention of carpal tunnel syndrome in one of two hands
* Unilateral carpal tunnel syndrome
* Patients with chronic pain and / or previous injury (wrist tumor, lymphedema ...) in either hand
* Patients with systemic diseases (diabetes, thyroid ...)
* Patients with pharmacological treatment to take analgesia for any other chronic pathologies
* Subjects who have suffered from a neurological disease that affects the musculoskeletal system
* Mental illness that prevents the compression and / or realization of the study
* Patients with tattoos, scars and / or marks on any of the hands or distal forearm area
* Pregnant women and minors

Primary outcomes:
measure: To evaluate changes on pain
timeFrame: Changes in 8 weeks
Secondary outcomes:
measure: To evaluate changes on the function of the upper limb.
timeFrame: Changes in 8 weeks
Other outcomes:
measure: To evaluate catastrophism associated with pain.
timeFrame: Day 0 of the study
Locations:
city: Valencia
country: Spain
facility: Hospital de Manises
Study officials:
affiliation: Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili
name: Sonia Monterde, PT, Phd
role: STUDY_DIRECTOR
References:
citation: Lázaro C, Fèlix B, Torrubia R, Baños JE. The development of a Spanish questionnaire for assessing pain: preliminary data concerning reliability and validity. Eur J Psychol assesment. 1994;10(2):145-51.
citation: Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
citation: Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.