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Completed

NCT Number: NCT05115396

Effectiveness of Mirror Therapy in Patients With Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most prevalent entrapment neuropathy. CTS presents with motor and sensory disturbances, including pain, paraesthesia, and numbness in the fingers and hand. Therefore, CTS has a great impact on the activities of daily living.

There are non-surgical treatments that can be effective in people who experience mild or moderate symptoms derived from CTS. Among them, flexor tendon and median nerve sliding exercises may offer an improvement in pain severity and symptoms, strength, wrist joint range, functionality, and quality of life for people with CTS. However, there are few studies on the effectiveness of treatments focused on the mechanisms of neuroplasticity through techniques aimed at rehabilitating different deficits.

Mirror therapy (MT) may be beneficial in musculoskeletal injuries that occur with pain and reduced functionality of a body segment. For example, in people with acute stroke, orthopaedic hand injuries or complex regional pain syndrome type 1. However, its effect has not been studied in patients with CTS in mild or moderate stages.

Thus, the objective of this study is to analyze the effectiveness of MT with conventional CTS exercises in symptoms of median nerve compression, pain, mobility, strength and motor functionality in patients with CTS.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy, Valencia, Valencia / València, Spain

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About this study

Carpal tunnel syndrome (CTS) is the most prevalent entrapment neuropathy. CTS presents with motor and sensory disturbances, including pain, paresthesia, and numbness in the fingers and hand. In addition, since complex movements and tactile sensation of the hand are essential to perform everyday tasks, STC has a great impact on the activities of daily living.

Previuos studies have shown that CTS is not merely a local compression of the median nerve, since associated peripheral and central sensitization phenomena have been verified. In this sense, the decrease in the use of a body segment as a form of protective response to pain, favors the reduction of cortical thickness, affecting the primary motor and somatosensory area. In this way, in patients with CTS it has been described that the modification of the sensory input ends up having an impact on the level of the central nervous system producing different brain plastic changes.

There are non-surgical treatments that can be effective in people who experience mild or moderate symptoms derived from CTS. Among them, flexor tendon and median nerve sliding exercises may offer an improvement in pain severity and symptoms, strength, wrist joint range, functionality, and quality of life for people with CTS. However, there are few studies on the effectiveness of treatments focused on the mechanisms of neuroplasticity through techniques aimed at rehabilitating different deficits.

Mirror therapy (MT), which involves the activation of mirror neurons and contributes to the cortical representation of movement, has been shown to be beneficial in musculoskeletal injuries that occur with pain and reduced functionality of a body segment. Furthermore, it has been shown to be effective in motor recovery of the upper limb in patients with acute stroke, the restoration of joint range and hand function in patients with orthopedic hand injuries, and in the improvement of pain in patients with complex regional pain syndrome type 1.

Similarly, in CTS, the application of MT decreases pain at rest during the night, and improves sensitivity and function in patients undergoing CTS hand surgery. However, its effect has not been studied in patients with CTS in mild or moderate stages where surgical treatment is not urgent or indicated.

Thus, the objective of this study will analyze the effectiveness of MT in combination with conventional exercises compared to conventional exercises on aspects related to symptoms of median nerve compression, pain, joint range, tension strength and motor functionality of the hand in patients with CTS.

Therefore, this study is a randomized clinical trial in which two groups of twenty people in each group will participate, with different interventions:

  • Mirror therapy group.
  • Cross-education group (without mirror). Participants will receive six-week intervention, 2 supervised sessions per week and 3 unsupervised sessions per week.

Participants will be evaluated in three moments, at baseline, postintervention and one-month-follow-up.

Data analysis will be performed with SPSS statistic program (v26). Normality and homoscedasticity will be analyzed by Shapiro-Wilk t-test and Levene test, respectively. For comparation between groups Bonferroni will be used. If any confusion factor that not meet requirements to be analysed like a covariable exist, ANCOVA will be used. When p<0.0.5 statistical significant differences will be assumed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being over 18 years of age.
  • Being diagnosed with CTS
  • Unilateral CTS

Exclusion criteria

  • trauma or surgery on the upper limb within the last two years.
  • diagnosis of severe CTS.
  • pregnancy.
  • atrophy of the tenar muscles.
  • local corticosteroid injection or physiotherapy for CTS within the last 3 months.
  • peripheral nerve damage.
  • entrapment neuropathy at the most proximal levels of the upper limb.

Treatment and study plan

Mirror Therapy

Other

The patient shall be seated in a chair with a table in front of him/her. On the table there is a mirror in the sagittal plane between the two upper extremities. The affected hand will be behind the mirror, without visibility, while the hand without symptoms will be reflected laterally in the mirror. Thus, the mirror will reflect the movements of the unaffected side as if these movements were executed with the affected side. During the procedure, patients will be instructed to concentrate on the hand reflected in the mirror.

Cross-education treatment

Other

Participants will perform the same exercise protocol with the unaffected hand and without the use of a mirror.

Primary outcomes

  1. Pain intensity

    Time frame: 2 minutes

    Visual Analog Scale: 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  2. Symptom severity and functional status

    Time frame: 5 minutes

    Boston Carpal Tunnel Syndrome Questionnaire

Secondary outcomes

  1. Upper limb disability

    Time frame: 5 minutes

    Shortened version of the Disabilities of the Arm, Shoulder, and Hand

  2. Grip and Gripper Strength

    Time frame: 10 minutes

    Dynamometer

  3. Sensitivity

    Time frame: 10 minutes

    Two-point discrimination, and The Semmes-Weinstein monofilament test

  4. Muscle activation

    Time frame: 10 minutes

    BTS FreeEMG electromyograph (wrist flexors, wrist extensors, thumb abductor).

  5. Perception of change after treatment

    Time frame: 2 minutes

    Patient Global Impression of Change Scale: 7-point verbal scale, with the options "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", "very much worse". Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2021
Registry last updated
May 15, 2023

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

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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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