NCT05592067

Brief Summary

The aim of this study is to compare the effectiveness of different kinesio taping techniques applied in carpal tunnel syndrome on pain, mobility, functional status and electrophysiological results and to investigate whether they are superior to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

October 14, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

October 14, 2022

Last Update Submit

December 22, 2023

Conditions

Keywords

kinesiotapingelectrophysiological findingscarpal tunel syndrome

Outcome Measures

Primary Outcomes (9)

  • Visual Analog Scale

    The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

    0 (baseline)

  • Visual Analog Scale

    The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

    3 th week

  • Visual Analog Scale

    The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

    12 th week

  • Hand grip strength

    Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms

    0 (baseline)

  • hand grip strength

    Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms

    3 th week

  • hand grip strength

    Jamar dynamometer will be used to measure hand grip strength. Jamar dynamometer measures static grip strength in pounds and kilograms. Measurements will be made with the patient in a sitting position, arm adducted, elbow flexed to 90 degrees, forearm in neutral position, as recommended by the American Association of Hand Therapists. Patients are asked to squeeze the dynamometer for at least 3 seconds with maximum contraction. 3 measurements are made with a 1 minute break between measurements. The average of 3 measurements is recorded in kilograms

    12 th week

  • electrophysiologıcal Findings

    Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.

    0 (baseline)

  • electrophysiologıcal Findings

    Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.

    3 th week

  • electrophysiologıcal Findings

    Median sensory nerve action potential amplitude, Compound muscle action potential amplitude, Median sensory distal latency, Median motor distal latency, Median sensory nerve conduction velocity, was evaluated by EMG.

    12 th week

Secondary Outcomes (3)

  • function

    0 (baseline)

  • function

    3 th week

  • function

    12 th week

Study Arms (3)

I tape technique

ACTIVE COMPARATOR

I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

Other: I tape techniqueOther: exercises

Button hole technique

ACTIVE COMPARATOR

Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

Other: Button hole techniqueOther: exercises

exercises

OTHER

exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

Other: exercises

Interventions

I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

I tape technique

Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day.

Button hole technique

exercises will be taught to the patient and a total of 21 sessions will be applied once a day

Button hole techniqueI tape techniqueexercises

Eligibility Criteria

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

You may qualify if:

  • Female and male patients aged 18-65 years who applied to Ahi Evran University Physical Medicine and Rehabilitation Outpatient Clinic and diagnosed with mild to moderate carpal tunnel syndrome by clinical and EMG
  • Patients who can correctly understand what is stated in the patient information form and have cooperation
  • Patients who consented to participate in the study according to the informed consent form

You may not qualify if:

  • Cervical radiculopathy
  • Polyneuropathy
  • Brachial plexopathy
  • Systemic corticosteroid use
  • History of fracture and trauma in the treated side forearm and wrist
  • Inflammatory rheumatic disease
  • Pregnant and lactating patients
  • Systemic diseases such as renal insufficiency, peptic ulcer, DM, hypothyroidism, coagulation disorder
  • Patients undergoing carpal tunnel syndrome surgery
  • Thoracic outlet syndrome
  • Thenar atrophy, severe carpal tunnel syndrome
  • The patient is reluctant or states that he cannot participate for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kirşehir, City Centre, 40100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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
  • Yildirim P, Dilek B, Sahin E, Gulbahar S, Kizil R. Ultrasonographic and clinical evaluation of additional contribution of kinesiotaping to tendon and nerve gliding exercises in the treatment of carpal tunnel syndrome. Turk J Med Sci. 2018 Oct 31;48(5):925-932. doi: 10.3906/sag-1709-72.

    PMID: 30384555BACKGROUND
  • Krause D, Roll SC, Javaherian-Dysinger H, Daher N. Comparative efficacy of the dorsal application of Kinesio tape and splinting for carpal tunnel syndrome: A randomized controlled trial. J Hand Ther. 2021 Jul-Sep;34(3):351-361. doi: 10.1016/j.jht.2020.03.010. Epub 2020 Sep 4.

  • Sahin MA, Cigdem-Karacay B, Konar NM, Tuncay F. Comparison of the Effectiveness of 2 Different Kinesio Taping Techniques Added to Exercises in the Treatment of Carpal Tunnel Syndrome: Randomized Controlled Trial, Double-Blind, Parallel Groups. Arch Phys Med Rehabil. 2024 Sep;105(9):1657-1665. doi: 10.1016/j.apmr.2024.05.023. Epub 2024 Jun 6.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Basak Cigdem Karacay, Asisst Prof

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and Outcomes Assessor are blind.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomly divided into 3 groups.Group A (kinesio taping with I tape technique + exercise to tendon and median nerve slipping), Group B (kinesio taping with button hole technique + exercise to tendon and median nerve slipping) and They will be divided into Group C (tendon and median nerve gliding exercise). In the first group, kinesio taping with the I tape technique described by Dr Kenzo Kase will be applied once a week, a total of 3 times, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day. In the second group, kinesio taping with the Button hole technique defined by Dr Kenzo Kase will be applied once a week, 3 times in total, and the exercises will be taught to the patient and a total of 21 sessions will be applied once a day. In the third group, exercises will be taught to the patient and a total of 21 sessions will be applied once a day.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor, asisst prof

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 24, 2022

Study Start

October 15, 2022

Primary Completion

January 1, 2023

Study Completion

August 1, 2023

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations