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

NCT03792945 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: AhiEvranUERH
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

extracorporeal shock wave therapy; corticosteroid injection

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) - Pain

  VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.

  3. months after treatment

• Visual Analog Scale (VAS) - Numbness

  VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.

  3. months after treatment

Secondary Outcomes (8)

• hand clamping force

  3. months after treatment

• boston scale

  3. months after treatment

• Median nerve sensory distal latency(electrophysiological examination,physiological parameter)

  3. months after treatment

• Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)

  3. months after treatment

• Median nerve motor distal latency( electrophysiological examination, physiological parameter)

  3. months after treatment

Study Arms (3)

extracorporeal shock wave therapy

ACTIVE COMPARATOR

ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Device: extracorporeal shock wave therapy

local injection

ACTIVE COMPARATOR

40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Drug: local injection

carpal tunnel wrist brace

NO INTERVENTION

Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Interventions

local injection DRUG

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

Also known as: local corticosteroid injection

local injection

extracorporeal shock wave therapy DEVICE

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

Also known as: physiotheraphy

extracorporeal shock wave therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG.
• Patients who are able to understand and correctly understand the patient information form
• Patients consenting to participate in the study according to the informed consent form

You may not qualify if:

• 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 patients
• Patients with cardiac pacemakers
• Patients undergoing carpal tunnel syndrome surgery
• Thoracic outlet syndrome
• Severe atrophy
• Severe carpal tunnel syndrome
• Patients who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the patient is not in favor of the patient,
• Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Ahi Evran University Education and Research Hospital

Kırşehir, Turkey (Türkiye)

Location

Related Publications (1)

• Ozturk Durmaz H, Tuncay F, Durmaz H, Erdem HR. Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Jul 1;101(7):685-692. doi: 10.1097/PHM.0000000000001891. Epub 2021 Oct 4.

  PMID: 35706121 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Tenosynovitis

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Havva ÖZTÜRK DURMAZ

  Ahi Evran University Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor Havva ÖZTÜRK DURMAZ

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: January 4, 2019
• Study Start: January 20, 2019
• Primary Completion: April 29, 2019
• Study Completion: May 29, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)