NCT05475197

Brief Summary

The design of our study is a randomized, controlled, double-blind study. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the acute effects of two different kinesio tape applications on the carpal tunnel in patients with carpal tunnel syndrome by ultrasonographic method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

June 2, 2023

Status Verified

June 1, 2023

Enrollment Period

2 months

First QC Date

July 22, 2022

Last Update Submit

June 1, 2023

Conditions

Keywords

Carpal Tunnel Syndrome,UltrasoundKinesio taping

Outcome Measures

Primary Outcomes (4)

  • Baseline ultrasonographic measurements

    Ultrasonographic measurements will be made using linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel assessments will be performed while the patients are sitting with their hands in a neutral position. By avoiding compression of the probe on the tissue by using plenty of gel, skin-subcutaneous tissue thickness, vertical and horizontal axis length and diameter of the median nerve, carpal ligament thickness, carpal ligament and median nerve distances to the skin will have measured. It will have measured in proximal and distal carpal tunnel levels.

    Just before Kinesio Taping application

  • After the application of ultrasonographic measurements

    Ultrasonographic measurements will be made using linear probes (5-13 MHz Logiq P5; GE Medical Systems). Carpal tunnel assessments will be performed while the patients are sitting with their hands in a neutral position. By avoiding compression of the probe on the tissue by using plenty of gel, skin-subcutaneous tissue thickness, vertical and horizontal axis length and diameter of the median nerve, carpal ligament thickness, carpal ligament and median nerve distances to the skin will be measured from the proximal and distal carpal tunnel levels.

    Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)

  • Baseline pain pressure threshold

    Pain pressure threshold will be assessed through the carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).Assessments will be performed while the patients are sitting with their hands in a neutral position.

    Just before Kinesio Taping application

  • After the application of pain pressure threshold

    Pain pressure threshold will be assessed through the carpal tunnel with a mechanical algometer (J Tech Medical, Salt Lake City, UT, USA).Assessments will be performed while the patients are sitting with their hands in a neutral position.

    Immediately after the tapes are removed after the Kinesio Taping application (48 hours later)

Study Arms (2)

Kinesio taping Type 1

EXPERIMENTAL

For the first group; While the wrist is 30° extension, the forearm is supinated and the elbow is extended, the distance between the 1st metacarpal joint and the medial epicondyles of the patient up to 5 cm below the median epicondyle will be measured. Two strips with width of 2.5 cm will be prepared. For the median nerve, the first band will be adhered along the nerve trachea by stretching of moderate intensity (50%) from the 2nd and 3rd metacarpophalangeal joint to 5 cm below the medial epicondyle. The second strip will be applied without stretching to a distance of 5 cm under the medial epicondyle from the 4th and 5th metacarpophalangeal joint. In addition, a strip half the length of the wrist circumference will be adhered to the volar face of the wrist by applying tension to the middle 1/3 of it, without applying tension to both ends.

Device: Kinesio taping

Kinesio taping Type 2

EXPERIMENTAL

For the second group; While the elbow is in full extension and the wrist in the extension and supination position, the distal two free ends of the tape will be adhered to the thenar and hypothenar regions without stretching. The middle 1/3 of the X-shaped tape will be adhered to the forearm volar face by applying moderate stretching.The first half of the two proximal free ends will have adhered to the medial and lateral epicondyle with little or no stretching, and the last half without any stretching. The I-shaped tape will be adhered to the radial region of the wrist with the elbow in full extension, the wrist in a neutral position, and the palm closed. The middle of the tape will be stretched lightly and moderately, and the last 1/3 of it will be adhered to the ulnar part of the wrist without stretching. Kinesio taping will be applied to both groups once.

Device: Kinesio taping

Interventions

We planned to perform two different taping applications to evaluate the acute effect of kinesio taping application on the carpal tunnels of individuals with carpal tunnel syndrome.

Kinesio taping Type 1Kinesio taping Type 2

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of moderate-mild carpal tunnel syndrome according to EMG findings
  • Patients who read the informed consent form and volunteered to participate in the study

You may not qualify if:

  • Patients with predisposing etiological factors (diabetes mellitus, acute trauma, rheumatological diseases, chronic kidney failure, pregnancy, hypothyroidism, hyperthyroidism, etc.) for carpal tunnel syndrome that may cause polyneuropathy.
  • Patients receiving regular medical treatment such as continuous NSAIDs
  • Patients who have received physical therapy or local steroid injection to the carpal tunnel region in the last 3 months
  • Patients undergoing carpal tunnel surgery
  • Patients with severe carpal tunnel syndrome
  • Patients with a history of malignancy
  • Patients with a history of cervical radiculopathy and ulnar neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Department of Physical Medicine and Rehabilitation

Mersin, 33110, Turkey (Türkiye)

Location

Related Publications (1)

  • Guvener O, Dag F, Sahin G, Ozcakar L. Immediate effects of Kinesio taping in carpal tunnel syndrome: A randomized controlled double-blind ultrasonographic study. J Hand Ther. 2024 Oct-Dec;37(4):520-528. doi: 10.1016/j.jht.2023.12.017. Epub 2024 Feb 15.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Orhan Güvener, MD

    Mersin University Medical School

    PRINCIPAL INVESTIGATOR
  • Figen Dağ, PhD

    Mersin University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 26, 2022

Study Start

November 15, 2022

Primary Completion

January 15, 2023

Study Completion

February 15, 2023

Last Updated

June 2, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations