Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)

Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)

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

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Mirror therapy; Other: Placebo group

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46940
    • Hospital de Manises

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mirror therapy group; Mirror therapy group: exercises looking at the reflection in the mirror of the hand moving	Other: Mirror therapy; The treatment proposed for the mirror group consisted of 8 weeks of treatment, performing a series of exercises 2 times a day / 4 times a week. The first 4 weeks the treatment was done in the hospital next to the physiotherapist for 2-3 days a week, and the next 4 weeks the patient performed the exercises following the same guidelines at home.; Other Names: Mirror visual feedback; Mirror box therapy
PLACEBO_COMPARATOR: Placebo group; Placebo group: exercises performed with the mirror turned to avoid the reflection of the hand and looking at the hand that did not remain hidden.	Other: Placebo group; The treatment was the same than proposed in inference group but with a mirror covered to avoid the reflexion on the hand and looking at the hand that did not remain hidden.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate changes on pain	Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.	Changes in 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate changes on the function of the upper limb.	Evaluation on function through disabilities of the arm, shoulder and hand questionnaire (DASH)	Changes in 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate catastrophism associated with pain.	Evaluation through Pain Catastrophizing Scale This questionnaire is self-administered	Day 0 of the study

Collaborators and Investigators

• Sponsor: Olga Del Pozo Blanco
• Collaborators: Hospital Universitario La Fe; University Rovira i Virgili
• Investigators: Study Director: Sonia Monterde, PT, Phd, Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2015
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Humans; Chronic pain; Adult; Physiotherapy; Exercise therapy; Neuronal plasticity; Mirror neurons; Somatosensory cortex; Entrapment neuropathy. Carpal tunnel; Pain/cognitive aspects
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: HManises; 2015/0277 (OTHER: CEIC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No