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Carpal Tunnel SyndromeNCT05115396

Effectiveness of Mirror Therapy in Patients With Carpal Tunnel Syndrome

A study testing Mirror therapy and Cross-education treatment in people with Carpal Tunnel Syndrome, run by University of Valencia at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Mirror therapy and Cross-education treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesSpain
Study dates
1 Dec 2021to 26 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites
  • Faculty of Physiotherapy

    Valencia, Valencia / València, 46010

  • Faculty of Physiotherapy

    Valencia, 46010

Other trials in Spain

About this study

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.

Read more

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.

Read the 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.

Being tested
Mirror therapy, Cross-education treatment
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirror therapyOther

    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 treatmentOther

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

Study groups in NCT05115396
Study groupRoleWhat they receive
Mirror therapyExperimentalTo perform mirror therapy, the participant shall be seated in a chair with a table in front of him/her. On the table there will be a mirror in the sagittal plane between the two upper limbs. 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 intervention, participants will be instructed to concentrate on the hand reflected in the mirror. During MT, they will perform an exercise protocol based on previous studies and the American College of Sports Medicine guidelines. The duration will be 30 minutes.
Receives: Other: Mirror therapy
Cross-education treatmentActive comparatorParticipants will perform the same exercise protocol with the unaffected hand and without the use of a mirror.
Receives: Other: Cross-education treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity

    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.

    Measured: 2 minutes

  2. Symptom severity and functional status

    Boston Carpal Tunnel Syndrome Questionnaire

    Measured: 5 minutes

Secondary outcomes (5)
  1. Upper limb disability

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

    Measured: 5 minutes

  2. Grip and Gripper Strength

    Dynamometer

    Measured: 10 minutes

  3. Sensitivity

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

    Measured: 10 minutes

  4. Muscle activation

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

    Measured: 10 minutes

  5. Perception of change after treatment

    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.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion26 Jul 2022
  4. Study completion26 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05115396
Sponsor's protocol ID
221021
Status last verified
Oct 2021
First submitted
29 Oct 2021
Last updated
15 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29993119
  • Jose Jerome JT, Surendran G, Thirumagal K. Upper Limb Reconstruction in Arthrogryposis Multiplex Congenita: A Systematic Review. J Hand Surg Am. 2026 Sep;51(9):984-998. doi: 10.1016/j.jhsa.2026.05.010. Epub 2026 Jun 18.

    PubMed 42313045
  • Munoz-Gomez E, Aguilar-Rodriguez M, Molla-Casanova S, Sempere-Rubio N, Ingles M, Serra-Ano P. A randomized controlled trial on the effectiveness of mirror therapy in improving strength, range of movement and muscle activity, in people with carpal tunnel syndrome. J Hand Ther. 2024 Oct-Dec;37(4):534-543. doi: 10.1016/j.jht.2024.02.007. Epub 2024 Mar 7.

    PubMed 38458950
  • Munoz-Gomez E, Aguilar-Rodriguez M, Ingles M, Molla-Casanova S, Sempere-Rubio N, Serra-Ano P. Effects of mirror therapy on pain, sensitivity and functionality in patients with unilateral carpal tunnel syndrome. Randomised control trial. Disabil Rehabil. 2024 Oct;46(20):4655-4663. doi: 10.1080/09638288.2023.2280705. Epub 2023 Nov 10.

    PubMed 37947269

Questions about this trial

What is this clinical trial studying?

A study testing Mirror therapy and Cross-education treatment in people with Carpal Tunnel Syndrome, run by University of Valencia at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: 2 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05115396, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.

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