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Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS

NCT03792945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-04-28

No results posted yet for this study

Summary

In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded.The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once.

And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer.

Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.

Conditions

  • Carpal Tunnel Syndrome
  • Tenosynovitis

Interventions

DRUG

local injection

In addition to the local injection, carpal tunnel brace will be given.

DEVICE

extracorporeal shock wave therapy

In addition to all ESWT participants, carpal tunnel brace will be given.

Sponsors & Collaborators

  • Ahi Evran University Education and Research Hospital

    lead OTHER

Principal Investigators

  • Havva ÖZTÜRK DURMAZ · Ahi Evran University Education and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2019-04-29
Completion
2019-05-29
FDA Drug
Yes
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03792945 on ClinicalTrials.gov