NCT05115396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

May 15, 2023

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

October 29, 2021

Last Update Submit

May 12, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 minutes

  • Symptom severity and functional status

    Boston Carpal Tunnel Syndrome Questionnaire

    5 minutes

Secondary Outcomes (5)

  • Upper limb disability

    5 minutes

  • Grip and Gripper Strength

    10 minutes

  • Sensitivity

    10 minutes

  • Muscle activation

    10 minutes

  • Perception of change after treatment

    2 minutes

Study Arms (2)

Mirror therapy

EXPERIMENTAL

To 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.

Other: Mirror therapy

Cross-education treatment

ACTIVE COMPARATOR

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

Other: Cross-education treatment

Interventions

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.

Mirror therapy

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

Cross-education treatment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physiotherapy

Valencia, Valencia / València, 46010, Spain

Location

Faculty of Physiotherapy

Valencia, 46010, Spain

Location

Related Publications (2)

  • 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.

    PMID: 29993119BACKGROUND
  • 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.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Pilar Serra-Añó, Dr

    Univeristy of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2021

First Posted

November 10, 2021

Study Start

December 1, 2021

Primary Completion

July 26, 2022

Study Completion

July 26, 2022

Last Updated

May 15, 2023

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations