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

Carpal Tunnel Syndrome Clinical Trial

— MTSTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169218
• Other study ID #: HManises
• Secondary ID: 2015/0277
• Status: Completed
• Phase: N/A
• First received: May 22, 2017
• Last updated: May 26, 2017
• Start date: October 2015
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Hospital de Manises
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital de Manises	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Olga Del Pozo Blanco	Hospital Universitario La Fe, University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (3)

García 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. Spanish. — View Citation

Hervás MT, Navarro Collado MJ, Peiró S, Rodrigo Pérez JL, López Matéu P, Martínez 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. Spanish. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate catastrophism associated with pain.	Evaluation through Pain Catastrophizing Scale This questionnaire is self-administered	Day 0 of the study
Primary	To evaluate changes on pain	Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.	Changes in 8 weeks
Secondary	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