NCT04993703

Brief Summary

Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the median nerve at the level of the wrist. Different types of splints are used for improving the function and decreasing the pain intensity and symptoms in the rehabilitation of patients with CTS. However effectiveness of treatment by taping has never been investigated in physiotherapy and rehabilitation. The aim of this study was to compare the short-term effect of conventional physiotherapy only, and also kinesio taping and night splinting in patients with CTS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

July 8, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

July 8, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

carpal tunnel syndromenight splintingkinesiotapingphysiotherapy and rehabilitation

Outcome Measures

Primary Outcomes (1)

  • functional impairment

    functional impairment will be assessed by using Boston Carpal Tunnel Questionnaire. The score consisted of two sub-scales; The Symptom Severity Scale including 11 questions and The Functional Capacity Scale including 8 questions. Each scale score is calculated by the average values of the questions. The scores vary between "1-point" to "5-point". High score indicates severe symptoms and impaired functional capacity.

    functional impairment will be recorded at baseline and 4-week follow-up

Secondary Outcomes (2)

  • pain intensity

    change from baseline to 4-week follow-up will be recorded

  • paresthesia

    change from baseline to 4-week follow-up will be recorded

Study Arms (3)

Kinesiotaping

EXPERIMENTAL

A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Additionally for this group, kinesiotaping will be applied by using carpal tunnel technique including button hole and I band technique of space correction; and with 25-50% tension in center of tape over dorsal carpal tunnel at the end of the each session. Patients will request to keep kinesiotaping at nights throughout the study.

Other: Kinesiotaping

Night splinting

EXPERIMENTAL

A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied. Additionally, night splinting will be advised. Patients will request to keep their splints at nights throughout the study.

Other: Night Splinting

Control group

EXPERIMENTAL

A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3sets of ten repetitions) will be applied.

Other: Control Group

Interventions

A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, kinesiotaping and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.times per day 3sets of ten repetitions) will be applied.

Kinesiotaping

A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, night splinting and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.

Night splinting

A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.

Control group

Eligibility Criteria

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

You may qualify if:

  • This study included patients with moderate CTS, confirmed by electroneurographic examination.
  • did not recruit any treatment (including physiotherapy or surgical release)

You may not qualify if:

  • Patients suffer from the thenar muscle atrophy.
  • Patients with mild CTS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Eraslan L, Baltaci G. Effectiveness of Kinesio Taping and Night Splinting Along With Physical Therapy Intervention on Symptoms and Functionality: A Double-Blind Randomized Controlled Trial for Moderate Carpal Tunnel Syndrome. Am J Phys Med Rehabil. 2023 Nov 1;102(11):975-983. doi: 10.1097/PHM.0000000000002252. Epub 2023 Mar 29.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
Principal Investigator

Study Record Dates

First Submitted

July 8, 2021

First Posted

August 6, 2021

Study Start

August 10, 2021

Primary Completion

November 10, 2021

Study Completion

February 20, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations