NCT06981715

Brief Summary

This study was conducted to compare the effectiveness of different treatment combinations in individuals with carpal tunnel syndrome (CTS). Participants were divided into three groups: The control group received only night splinting and exercise programme, while the second group received extracorporeal shock wave therapy (ESWT) in addition. The third group received kinesiobanding in addition to night splinting, exercise and ESWT. The study evaluates the effect of multimodal conservative treatment approaches on CTS symptoms and aims to demonstrate the additional benefits of ESWT and kinesiobanding in particular. The findings provide important clues for clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

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

May 12, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

May 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2025

Completed
Last Updated

July 1, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

May 12, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

carpal tunnel syndrometreatmentkinesiotaping

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Visual Analogue Scale (VAS) was used to determine the presence and severity of low back pain in the study participants. GAS is a practical test with high validity and reliability in pain assessment. GAS is an assessment method numbered from 0 to 10, where '0' indicates no pain and '10' indicates the presence of the most severe pain. Participants were asked to mark the degree of pain they had on this scale and recorded.

    5 week

Secondary Outcomes (3)

  • Symptom Severity and Functionality

    5 week

  • Hand Grip Strength

    5 week

  • Electrophysiological Assessments

    5 week

Study Arms (3)

Control Group

EXPERIMENTAL

Control Group: Resting splint fixing the ankle in neutral position Worn every night before going to bed, used for 6-8 hours Objective: To reduce the pressure on the median nerve Exercise Programme: Applied 1-2 times a day Each exercise 10 repetitions, 2 sets Content: Nerve mobilisation exercises (median nerve sliding and stretching) Wrist stretching and flexor-extensor tendon sliding exercises Finger opening-closing, fist making exercises

Other: Conservative treatment

ESWT group

EXPERIMENTAL

ESWT group: Resting splint fixing the ankle in neutral position Worn every night before going to bed, used for 6-8 hours Objective: To reduce the pressure on the median nerve Exercise Programme: Applied 1 time per day Each exercise 10 repetitions, 2 sets Content: Nerve mobilisation exercises (median nerve sliding and stretching) Wrist stretching and flexor-extensor tendon sliding exercises Finger opening-closing, fist making exercises ESWT Protocol: Device Radial ESWT device Area of application Wrist volar surface (carpal tunnel area) Parameters Frequency: 5 Hz 4 Bar Number of beats 2000 pulses/session Application time 5-10 minutes per session

Other: Conservative treatmentOther: ESWT

ESWT+Taping Group

EXPERIMENTAL

ESWT+Taping Group: Resting splint fixing the ankle in neutral position Worn every night before going to bed, used for 6-8 hours Objective: To reduce the pressure on the median nerve Exercise Programme: Applied 1 time per day Each exercise 10 repetitions, 2 sets Content: Nerve mobilisation exercises (median nerve sliding and stretching) Wrist stretching and flexor-extensor tendon sliding exercises Finger opening-closing, fist making exercises ESWT Protocol: Device Radial ESWT device Area of application Wrist volar surface (carpal tunnel area) Parameters Frequency: 5 Hz 4 Bar Number of beats 2000 pulses/session Kinesiobanding technique Kinesio taping was performed with the Button hole technique described by Dr Kenzo Kase. In this technique, a kinesio tape was measured and cut from the medial and lateral epicondyle level on the palmar side of the forearm, from the base of the proximal phalanges to the epicondyles of the humerus on the dorsal side of the forearm.

Other: Conservative treatmentOther: ESWTOther: Kinesiotaping

Interventions

Night Splint Resting splint fixing the ankle in neutral position Worn every night before going to bed, used for 6-8 hours Objective: To reduce the pressure on the median nerve Exercise Programme: Applied 1-2 times a day Each exercise 10 repetitions, 2 sets Content: Nerve mobilisation exercises (median nerve sliding and stretching) Wrist stretching and flexor-extensor tendon sliding exercises Finger opening-closing, fist making exercises

Control GroupESWT groupESWT+Taping Group
ESWTOTHER

ESWT Protocol: Device Radial ESWT device Area of application Wrist volar surface (carpal tunnel area) Parameters Frequency: 5 Hz 4 Bar Number of beats 2000 pulses/session Application time 5-10 minutes per session

ESWT groupESWT+Taping Group

Kinesio taping was performed with the Button hole technique described by Dr Kenzo Kase. In this technique, a kinesio tape was measured and cut from the medial and lateral epicondyle level on the palmar side of the forearm, from the base of the proximal phalanges to the epicondyles of the humerus on the dorsal side of the forearm. The tape was folded and the midpoint was found, 2 short incisions were made and 2 button holes were obtained through which the 3rd and 4th finger would pass. The paper behind the band was torn and the 3rd and 4th fingers were passed through the holes. The patient's wrist was brought to extension and radial deviation and the tape was glued with a slight (15-25%) tension towards the medial epicondyle on the palmar side of the forearm. Then the wrist was flexed and ulnar deviated and the tape was glued with a slight (15-25%) tension towards the lateral epicondyle.

ESWT+Taping Group

Eligibility Criteria

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

You may qualify if:

  • Male or female patients between the ages of 18 and 65 who applied to Ahi Evran University Physical Medicine and Rehabilitation Outpatient Clinic and were diagnosed with moderate or mild carpal tunnel syndrome by clinical, physical examination and EMG
  • Patients who understand and can apply the patient information form
  • Patients who gave consent and participated in the study according to the informed consent form

You may not qualify if:

  • Cervical radiculopathy
  • Polyneuropathy
  • Brachial plexopathy
  • History of trauma or fracture of the wrist and forearm
  • Systemic corticosteroid use, history of malignancy
  • History of carpal tunnel syndrome surgery
  • Pregnant and lactating women
  • Severe carpal tunnel syndrome, tenar atrophy on physical examination 9.
  • Patient reluctance to participate in treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mehmet CANLI, PhD.

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 21, 2025

Study Start

May 17, 2025

Primary Completion

June 26, 2025

Study Completion

June 26, 2025

Last Updated

July 1, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations