Clinical trial NCT05115396: Effectiveness of Mirror Therapy in Patients With Carpal Tunnel Syndrome
Official title: Effectiveness of Mirror Therapy in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: 2 minutes
measure: Symptom severity and functional status
timeFrame: 5 minutes
Secondary outcomes:
measure: Upper limb disability
timeFrame: 5 minutes
measure: Grip and Gripper Strength
timeFrame: 10 minutes
measure: Sensitivity
timeFrame: 10 minutes
measure: Muscle activation
timeFrame: 10 minutes
measure: Perception of change after treatment
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
state: Valencia / València
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
Study officials:
affiliation: Univeristy of Valencia
name: Pilar Serra-Añó, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thieme H, Morkisch N, Mehrholz J, Pohl M, Behrens J, Borgetto B, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2018 Jul 11;7(7):CD008449. doi: 10.1002/14651858.CD008449.pub3.