Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05115396 |
| Other study ID # |
221021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
July 26, 2022 |
Study information
| Verified date |
October 2021 |
| Source |
University of Valencia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
