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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mirror therapy
Placebo group
Sponsored by
Olga Del Pozo Blanco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Adult, Chronic pain, Entrapment neuropathy. Carpal tunnel, Exercise therapy, Humans, Neuronal plasticity, Mirror neurons, Pain/cognitive aspects, Physiotherapy, Somatosensory cortex

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Manises

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mirror therapy group

Placebo group

Arm Description

Mirror therapy group: exercises looking at the reflection in the mirror of the hand moving

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.

Outcomes

Primary Outcome Measures

To evaluate changes on pain
Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.

Secondary Outcome Measures

To evaluate changes on the function of the upper limb.
Evaluation on function through disabilities of the arm, shoulder and hand questionnaire (DASH)

Full Information

First Posted
May 22, 2017
Last Updated
May 26, 2017
Sponsor
Olga Del Pozo Blanco
Collaborators
Hospital Universitario La Fe, University Rovira i Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT03169218
Brief Title
Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom
Acronym
MTSTC
Official Title
Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olga Del Pozo Blanco
Collaborators
Hospital Universitario La Fe, University Rovira i Virgili

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Adult, Chronic pain, Entrapment neuropathy. Carpal tunnel, Exercise therapy, Humans, Neuronal plasticity, Mirror neurons, Pain/cognitive aspects, Physiotherapy, Somatosensory cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy group
Arm Type
Experimental
Arm Description
Mirror therapy group: exercises looking at the reflection in the mirror of the hand moving
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Other Intervention Name(s)
Mirror visual feedback, Mirror box therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate changes on pain
Description
Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.
Time Frame
Changes in 8 weeks
Secondary Outcome Measure Information:
Title
To evaluate changes on the function of the upper limb.
Description
Evaluation on function through disabilities of the arm, shoulder and hand questionnaire (DASH)
Time Frame
Changes in 8 weeks
Other Pre-specified Outcome Measures:
Title
To evaluate catastrophism associated with pain.
Description
Evaluation through Pain Catastrophizing Scale This questionnaire is self-administered
Time Frame
Day 0 of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Monterde, PT, Phd
Organizational Affiliation
Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Manises
City
Valencia
ZIP/Postal Code
46940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
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PubMed Identifier
19007576
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.
Results Reference
background
PubMed Identifier
17040628
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.
Results Reference
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Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom

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