NCT05997823

Brief Summary

This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip strength, and electrophysiological parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

August 11, 2023

Last Update Submit

January 26, 2024

Conditions

Keywords

carpal tunnel syndromeskinesiotapeelectromyographymedian neuropathymuscle strengthpain

Outcome Measures

Primary Outcomes (4)

  • Electrodiagnostic Evaluation

    Superficial recording electrodes were placed in the abductor pollicis brevis (APB) muscles (recording stimulus distance 5 cm) for median nerve motor conduction and in the abductor digiti minimi (ADM) muscles (recording stimulus distance 5 cm) for ulnar nerve motor conduction.Superficial recording electrodes were placed on the 3rd finger for median nerve sensory conduction (recording stimulus distance 13 cm) and on the 5th finger for ulnar nerve sensory conduction (recording stimulus distance 11 cm).The ground electrode was placed between the recording and stimulus electrodes for all electrophysiological tests.Sensory latency, amplitude, and conduction velocity of the median nerve and motor latency, amplitude, and conduction velocity were recorded

    30 minutes

  • Hand Strength

    A Jamar hand dynamometer (Baseline ® hydraulic hand dynamometer, Irvington, NY, USA) was used to measure handgrip strength.

    10 minutes

  • Pain Evaluation

    A 10-point visual analog scale (VAS) was used to rate pain. Patients were asked to rate the pain they felt at rest, at night, and with movement with a number ranging from 0 (no pain) to 10 (very severe), VAS movement, VAS night, and VAS rest

    5 minutes

  • Finger Strength

    A pinch meter (Baseline ® hydraulic pinch gauge, Irvington, NY, USA) was used to evaluate lateral grip strength (LGS) and pinch grip strength

    10 minutes

Study Arms (3)

home exercises

ACTIVE COMPARATOR
Other: home exercises

sham-KT and home exercises

EXPERIMENTAL
Other: kinesiotapeOther: home exercises

dorso-volar KT and home exercises

EXPERIMENTAL
Other: kinesiotapeOther: home exercises

Interventions

The button hole technique was used for area correction during the KT application (Figure 1). Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side. The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension

dorso-volar KT and home exercisessham-KT and home exercises

home exercises

dorso-volar KT and home exerciseshome exercisessham-KT and home exercises

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pain or numbness radiating to the palm for at least 6 weeks,
  • at least one positive Tinel's, Phalen's, or carpal compression test on physical examination, and
  • mild/moderate CTS on EMG examination.

You may not qualify if:

  • Metabolic disease (diabetes, rheumatoid arthritis, thyroid disease),
  • systemic or malignant disease, history of trauma, fracture or surgery to the wrist,
  • physical therapy programs, surgical procedures, injections or KT applications to the wrist for CTS treatment in the past year,
  • severe thenar atrophy,
  • C6-C7 radiculopathy among CTS differential diagnoses,
  • cervical spondylosis, thoracic outlet syndrome, entrapment of the median nerve above the wrist,
  • polyneuropathy or traumatic injury to the median nerve,
  • rashes or open wounds on the skin of the wrist and forearm that could prevent treatment with kinesiology taping

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University, Kocaeli Derince Training and Research Hospital

Kocaeli, Deince, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian NeuropathyPain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

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
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 18, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 29, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations