NCT06464809

Brief Summary

The purpose of this study was to investigate the effectiveness of KT versus TENS combining self-myofascial stretching in treatment of CTS through clinical, functional assessment and sensory measurements. Primary hypothesis The KT group has a more substantial improvement in hand grip, pain relief, enhancing proprioceptive sensitivity and dexterity compare to the TENS group. treatment program,

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

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

September 24, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 18, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

June 4, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

Carpal tunnel syndromehome-based treatment programkinesio tapingparesthesiathenar eminence

Outcome Measures

Primary Outcomes (5)

  • The SSS and FSS of the Boston Carpal Tunnel Questionnaire (BCTQ)

    Assess symptoms and functional status. The SSS subscale includes 11 items assessing pain, paresthesia, numbness, weakness, nocturnal symptoms and over-all functional status. The FSS subscale includes 8 items assessing the hand function during common daily activities. Each item is scored on a 5-point scale (1-5), from 1(no symptoms) to 5 (the worst symptoms) for SSS, and from 1 (no difficulty) to 5 (cannot perform the activity at all) for FSS. The overall SSS and FSS scores are calculated as the mean of the scores for 11 and 8 individual items respectively, such that the higher the score obtained, the worse the SSS or FSS.

    pre-intervention, 4-week intervention, and 4-week follow-up.

  • Hand grip and key pinch strengths

    pinch strength included palmar, three-jaw chuck, tip, and lateral pinches.

    pre-intervention, 4-week intervention, and 4-week follow-up.

  • Two-point discrimination (2PD)

    cutaneous sensory perception threshold. The larger the value of distance, the worse the sensory ability.

    pre-intervention, 4-week intervention, and 4-week follow-up.

  • Modified Moberg pick-up test (MMPUT)

    hand dexterity. The shorter the time, the more dexterity the hand.

    pre-intervention, 4-week intervention, and 4-week follow-up.

  • The visual analog scale (VAS)

    pain measurement. 100 mm straight line, with 0 mm on the far left and 100 mm on the far right, 0 mm positions It is not painful, and 100 mm is extremely painful.

    pre-intervention, 4-week intervention, and 4-week follow-up.

Study Arms (2)

kinesio taping (KT) group

EXPERIMENTAL

Three precut KT I strips with a width of 5 cm were used. The first strip is applied with the subject's wrist in fully extended hand position. Middle and ring fingers through the holes with the base of the tape as anchored to the knuckles, and then the tape was applied with 15%-25% tension covering the palm and the wrist, and the remainder of the tape without any tension from the wrist up to the forearm. The same process is repeated for the second I-strip, which was applied from the dorsum of the hand to wrist while the wrist in a downward flexed position. The final strip was applied to the carpal tunnel region with 25%-35% tension.

Other: kinesio taping (KT)

transcutaneous electrical nerve stimulation (TENS) group

ACTIVE COMPARATOR

A portable TENS unit (Gem-Stim, Gemore Technology Co., LTD. Taiwan) was used, and delivered a bi-phasic symmetric waveform at a continuous frequency of 100 Hz and phase duration of 200 µsec. The intensity was gradually adjusted up to a strong but comfortable l level, as reported by the subject. Two electrodes were placed 2 cm apart, respectively attached to the carpal ligament of the affected side and the proximal end along the direction of the median nerve.

Other: kinesio taping (KT)

Interventions

Also known as: transcutaneous electrical nerve stimulation (TENS)
kinesio taping (KT) grouptranscutaneous electrical nerve stimulation (TENS) group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • numbness and tingling in the median nerve territory of the hand.
  • nocturnal paresthesia.
  • induction test (Tinel's sign and Phalen's test) showing a positive finding.,
  • is defined as mild and moderate CTS according to nerve conduction studies (NCSs).

You may not qualify if:

  • is defined severe CTS symptoms.
  • are currently pregnant or have any secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism, previous wrist trauma).
  • cervical radiculopathy or polyneuropathy.
  • previous history of carpal tunnel decompression surgery.
  • corticosteroid injection into the carpal tunnel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeParesthesia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Wei-Hsien Hong, PhD

    China Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants who met the inclusion criteria were randomized into one of two treatment groups: KT group and TENS group. Participants were blinded to the treatments used in the other group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This was a prospective, randomized-controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 18, 2024

Study Start

September 24, 2014

Primary Completion

November 30, 2015

Study Completion

December 30, 2015

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations