NCT06710041

Brief Summary

Objective: Kinesiotaping (KT) is a relatively new technique, which reduces the pressure on the median nerve by extending the transverse carpal ligament. The aim of this study was to evaluate the effectiveness of KT on Carpal tunnel syndrome (CTS) in a randomized, placebo-controlled manner. Methods: Patients were randomly divided into three groups: Group 1 (KT plus tendon and nerve gliding exercises), Group 2 (sham-taping plus exercises) and Group 3 (exercises alone, control group). KT was applied 3 times with 5-day intervals throughout the study, with "neural technique" for median and ulnar nerves and "area correction technique" for carpal tunnel releasing. In the placebo group kinesiotapes were applied without stretching and proper position. Hand grip strength, VAS, Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), and Short Form-12 (SF-12) were measured as outcome parameters at the first visit, 3rd and 6th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

November 21, 2024

Last Update Submit

November 25, 2024

Conditions

Keywords

carpal tunnel syndromeKinesiotapingSham taping

Outcome Measures

Primary Outcomes (1)

  • pain level

    pain level was assessed using visual analog scale.The minimum and maximum values were 0 and 10, and higher scores mean a better outcome.

    From enrollment to the end of treatment at 3 weeks

Secondary Outcomes (1)

  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

    From enrollment to the end of treatment at 6 weeks

Study Arms (3)

Kinesiotaping plus tendon and nerve gliding exercises

ACTIVE COMPARATOR

Kinesiotaping was applied 3 times with 5-day intervals

Device: KinesiotapeOther: Exercise

Sham taping plus tendon and nerve gliding exercises

SHAM COMPARATOR

Sham taping was applied 3 times with 5-day intervals without stretching and without having the proper position.

Other: ExerciseDevice: sham taping

tendon and nerve gliding exercises alone

OTHER

The control group received exercise therapy only

Other: Exercise

Interventions

Kinesiotape, when applied with a specific method and tension, significantly reduces the pressure on the median nerve by extending the transverse carpal ligament. It regulates edema under the skin and improves lymphatic and blood circulation. It reduces muscle spasms, eases the movement of tendons and fascia, and reduces pain through neurological suppression

Kinesiotaping plus tendon and nerve gliding exercises

Tendon and nerve gliding exercise

Kinesiotaping plus tendon and nerve gliding exercisesSham taping plus tendon and nerve gliding exercisestendon and nerve gliding exercises alone

In the sham taping group, kinesiotape was applied with two I bands without stretching and without having the proper position. This group was considered as the placebo group.

Sham taping plus tendon and nerve gliding exercises

Eligibility Criteria

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

You may qualify if:

  • clicical diagnosis of mild and moderate CTS
  • having the CTS symptoms for at least 6 weeks

You may not qualify if:

  • electrophysiological diagnosis of severe CTS,
  • thenar atrophy,
  • local corticosteroid injection or KT application or physical therapy treatment for CTS within the last 3 months,
  • patients with secondary metabolic causes for CTS (such as diabetes mellitus, pregnancy, rheumatoid arthritis, sarcoidosis, thyroid disease),
  • patients with other conditions that may cause neck and arm pain (cervical disc hernia, arthritis, epicondylitis, rotator cuff syndrome),
  • a history of fracture in the wrist,
  • previous CTS surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

Location

Related Publications (2)

  • Geler Kulcu D, Bursali C, Aktas I, Bozkurt Alp S, Unlu Ozkan F, Akpinar P. Kinesiotaping as an alternative treatment method for carpal tunnel syndrome. Turk J Med Sci. 2016 Jun 23;46(4):1042-9. doi: 10.3906/sag-1503-4.

    PMID: 27513402BACKGROUND
  • Giray E, Karali-Bingul D, Akyuz G. The Effectiveness of Kinesiotaping, Sham Taping or Exercises Only in Lateral Epicondylitis Treatment: A Randomized Controlled Study. PM R. 2019 Jul;11(7):681-693. doi: 10.1002/pmrj.12067. Epub 2019 Mar 28.

    PMID: 30609278BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Athletic TapeExercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 29, 2024

Study Start

July 1, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Locations