NCT03169218

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

May 22, 2017

Last Update Submit

May 26, 2017

Conditions

Keywords

AdultChronic painEntrapment neuropathy. Carpal tunnelExercise therapyHumansNeuronal plasticityMirror neuronsPain/cognitive aspectsPhysiotherapySomatosensory cortex

Outcome Measures

Primary Outcomes (1)

  • To evaluate changes on pain

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

    Changes in 8 weeks

Secondary Outcomes (1)

  • To evaluate changes on the function of the upper limb.

    Changes in 8 weeks

Other Outcomes (1)

  • To evaluate catastrophism associated with pain.

    Day 0 of the study

Study Arms (2)

Mirror therapy group

EXPERIMENTAL

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

Other: Mirror therapy

Placebo group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Mirror visual feedback, Mirror box therapy
Mirror therapy 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.

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Manises

Valencia, 46940, Spain

Location

Related Publications (3)

  • 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.

    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.

    PMID: 19007576BACKGROUND
  • 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.

    PMID: 17040628BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromeChronic PainMedian Neuropathy

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Sonia Monterde, PT, Phd

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 30, 2017

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations