Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome

NCT ID: NCT06321276

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-08-01

Brief Summary

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Different parameters have been used in studies investigating the efficacy of extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome. Although extracorporeal shock wave therapy has been shown to have a positive effect on carpal tunnel syndrome, there is no consensus on which pulse rate is more effective. Therefore, in this study, the efficacy of extracorporeal shock wave therapy applied at different pulse rates in the treatment of carpal tunnel syndrome will be examined.

Detailed Description

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The study included 72 patients with CTS aged 18-65 years who applied to Kırşehir Ahi Evran University Training and Research Hospital Physical Therapy and Rehabilitation Center.

Carpal tunnel syndrome (CTS) is the most common compressive neuropathy. In CTS, the median nerve is compressed within the carpal canal, about 1 to 2 cm beyond the distal wrist crease. It is more common in women and is typically more severe in the dominant hand but is often bilateral. Repetitive hand and wrist movements, such as using a keyboard or vibrating tools, have been associated with CTS. Medical conditions associated with CTS include diabetes, hypothyroidism and RA, as well as obesity and pregnancy. Rarely, CTS may be caused by a mass lesion in the wrist, such as a ganglion cyst or neurofibroma, or may be associated with acute trauma to the wrist. The vast majority of CTS cases are idiopathic.

CTS treatment is divided into conservative and surgical treatment. Conservative treatment methods are recommended in mild and moderate CTS patients, while surgical treatment is recommended in severe cases.

Extracorporeal Shock Wave Therapy is one of the physical therapy applications used in the treatment of Carpal Tunnel. The effectiveness of ESWT in the treatment of CTS will be examined

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

three groups with a conventional therapy control group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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two thousand pulse ESWT Group

ESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 2000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy)

Group Type ACTIVE_COMPARATOR

extracorporeal shockwave therapy

Intervention Type DEVICE

Extracorporeal shock wave therapy (ESWT) is a non-invasive procedure that uses single-pulse acoustic waves generated outside the body and focused on a specific area of the body. Shock waves promote axonal regeneration of peripheral nerves through various molecular reactions. Although the anti-nociceptive mechanisms of ESWT have not yet been elucidated, ESWT may produce analgesia through biochemical changes in the nerve fiber itself and reduce inflammation of soft tissues.

one thousand pulse ESWT Group

ESWT will be applied to the patient's wrist and conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises will be applied. The point of the ESWT site was located by ultrasonography interfaced with a 5-12 MHz linear array transducer, and the median nerve was visualized at the line of the proximal carpal tunnel (scaphoid pisiform level). (0,06 mj/mm2, 1000 impulses, 4 bar) (Modus ESWT Radial Shockwave Therapy)

Group Type ACTIVE_COMPARATOR

extracorporeal shockwave therapy

Intervention Type DEVICE

Extracorporeal shock wave therapy (ESWT) is a non-invasive procedure that uses single-pulse acoustic waves generated outside the body and focused on a specific area of the body. Shock waves promote axonal regeneration of peripheral nerves through various molecular reactions. Although the anti-nociceptive mechanisms of ESWT have not yet been elucidated, ESWT may produce analgesia through biochemical changes in the nerve fiber itself and reduce inflammation of soft tissues.

Conventional Control Group

The patient will receive conventional treatment consisting of hand-wrist rest splint and nerve gliding exercises as directed by the physiotherapist

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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extracorporeal shockwave therapy

Extracorporeal shock wave therapy (ESWT) is a non-invasive procedure that uses single-pulse acoustic waves generated outside the body and focused on a specific area of the body. Shock waves promote axonal regeneration of peripheral nerves through various molecular reactions. Although the anti-nociceptive mechanisms of ESWT have not yet been elucidated, ESWT may produce analgesia through biochemical changes in the nerve fiber itself and reduce inflammation of soft tissues.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged 18-65 years with carpal tunnel syndrome diagnosed clinically and by EMG
* Patients who can correctly understand what is stated in the patient information form and who can cooperate
* Patients who consent to participate in the study according to the informed consent form will be included in the study.

Exclusion Criteria

* Cervical radiculopathy
* Polyneuropathy
* Brachial plexopathy
* Use of systemic corticosteroids or local corticosteroid injections
* History of fracture and trauma in the forearm and wrist on the treated side
* Inflammatory rheumatic disease
* Pregnant and lactating patients
* Systemic diseases such as renal failure, peptic ulcer, DM, hypothyroidism, coagulation disorder
* Patients undergoing carpal tunnel syndrome surgery
* People with pacemakers
* Thoracic outlet syndrome
* Tenar atrophy, severe carpal tunnel syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Dogru

Physical medicine and rehabilitation MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ibrahim Doğru, MD

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran University Physical medicine & rehabilitation

Locations

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Kirsehir Ahi Evran University

Kırşehir, Kırşehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Huisstede BM, Hoogvliet P, Franke TP, Randsdorp MS, Koes BW. Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Aug;99(8):1623-1634.e23. doi: 10.1016/j.apmr.2017.08.482. Epub 2017 Sep 20.

Reference Type BACKGROUND
PMID: 28942118 (View on PubMed)

Kim JC, Jung SH, Lee SU, Lee SY. Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Aug;98(33):e16870. doi: 10.1097/MD.0000000000016870.

Reference Type BACKGROUND
PMID: 31415424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35706121 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/28942118/

Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials

https://pubmed.ncbi.nlm.nih.gov/31415424/

Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trials

https://pubmed.ncbi.nlm.nih.gov/35706121/

Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study

Other Identifiers

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AEU-FTR-ID-01

Identifier Type: -

Identifier Source: org_study_id

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