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

NCT ID: NCT03169218

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double Blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mirror therapy group

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

Group Type EXPERIMENTAL

Mirror therapy

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mirror visual feedback Mirror box therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario La Fe

OTHER

Sponsor Role collaborator

University Rovira i Virgili

OTHER

Sponsor Role collaborator

Olga Del Pozo Blanco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olga Del Pozo Blanco

Physiotherapist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sonia Monterde, PT, Phd

Role: STUDY_DIRECTOR

Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Manises

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19007576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17040628 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015/0277

Identifier Type: OTHER

Identifier Source: secondary_id

HManises

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bilateral vs Unilateral CTR
NCT01961011 UNKNOWN
Carpal Tunnel Release Efficacy Trial
NCT06934187 NOT_YET_RECRUITING NA