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

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ClinicalTrials.gov Identifier: NCT03169218
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Hospital Universitario La Fe
University Rovira i Virgili
Information provided by (Responsible Party):
Olga Del Pozo Blanco, Hospital de Manises

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Mirror therapy Other: Placebo group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom (MTSTC)
Actual Study Start Date : October 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017


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.




Primary Outcome Measures :
  1. To evaluate changes on pain [ Time Frame: Changes in 8 weeks ]
    Evaluation on pain through McGill Pain Questionnaire This questionnaire is self-administered.


Secondary Outcome Measures :
  1. To evaluate changes on the function of the upper limb. [ Time Frame: Changes in 8 weeks ]
    Evaluation on function through disabilities of the arm, shoulder and hand questionnaire (DASH)


Other Outcome Measures:
  1. To evaluate catastrophism associated with pain. [ Time Frame: Day 0 of the study ]
    Evaluation through Pain Catastrophizing Scale This questionnaire is self-administered



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169218


Locations
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Spain
Hospital de Manises
Valencia, Spain, 46940
Sponsors and Collaborators
Olga Del Pozo Blanco
Hospital Universitario La Fe
University Rovira i Virgili
Investigators
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Study Director: Sonia Monterde, PT, Phd Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili

Publications:
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Responsible Party: Olga Del Pozo Blanco, Physiotherapist, Hospital de Manises
ClinicalTrials.gov Identifier: NCT03169218     History of Changes
Other Study ID Numbers: HManises
2015/0277 ( Other Identifier: CEIC )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Olga Del Pozo Blanco, Hospital de Manises:
Adult
Chronic pain
Entrapment neuropathy. Carpal tunnel
Exercise therapy
Humans
Neuronal plasticity
Mirror neurons
Pain/cognitive aspects
Physiotherapy
Somatosensory cortex

Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries