NCT03792945

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

Comparison of the Efficacy of Corticosteroid Injection and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Carpal Tunnel Syndrome; A Prospective Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Ahi Evran University Education and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection 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. Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid treatment, fracture and trauma history of the treated side anterior arm and wrist, inflammatory rheumatic disease, pregnant and lactating participants, participants with cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the participants is not in favor of the participants, systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90 idiopathic moderate and mild CTS participants 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

Type	Name	Description
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.

Timeline

• Start date: 2019-01-20
• Primary completion: 2019-04-29
• Completion: 2019-05-29
• First posted: 2019-01-04
• Last updated: 2020-04-28

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study
• FDA-regulated device study