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Completed

NCT Number: NCT03169218

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

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

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Key information

Conditions

Carpal Tunnel Syndrome Chronic Pain Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Manises

Valencia, 46940, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirror Therapy

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.

Other names: Mirror visual feedback, Mirror box therapy

Placebo Group

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.

Primary outcomes

  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 outcomes

  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 outcomes

  1. To evaluate catastrophism associated with pain.

    Time frame: Day 0 of the study

    Evaluation through Pain Catastrophizing Scale This questionnaire is self-administered

Sponsors and collaborators

Lead sponsor

Olga Del Pozo Blanco

Other

Collaborators

  • Hospital Universitario La Fe
  • University Rovira i Virgili

Registry information

Official study title

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

Acronym: MTSTC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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