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

NCT06321276 | Completed

• 1 other identifier: AEU-FTR-ID-01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Keywords

rehabilitation; extracorporeal shock wave therapy; physical therapy

Outcome Measures

Primary Outcomes (2)

• Visual analogue scale (VAS)

  A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity

  0. week , 4. week , 12. week

• Boston Carpal Tunnel Syndrome Questionnaire

  It assesses the severity of symptoms and functional status. The symptom severity scale (SSS) assesses symptoms according to severity, frequency, time and type. The scale consists of 11 questions with multiple-choice answers scored from 1 point (mildest) to 5 points (most severe). The overall symptom severity score is calculated as the average of the scores for the 11 individual items. Functional status scale (FSS) assesses the impact of CTS on daily life. The scale consists of eight multiple-choice questions scored from 1 point (no difficulty in the activity) to 5 points (unable to do the activity at all). The total score for functional status was calculated as the average of all eight. Therefore, a higher symptom severity or functional status score indicates worse symptoms or impaired function.

  0. week, 4. week , 12. week

Secondary Outcomes (3)

• Hand grip strength measurement

  0. week, 4. week, 12. week

• Electromyoneurography (EMNG)

  0. week, 12. week

• Ultrasonography

  0. week, 12. week

Study Arms (3)

two thousand pulse ESWT Group

ACTIVE COMPARATOR

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)

Device: extracorporeal shockwave therapy

one thousand pulse ESWT Group

ACTIVE COMPARATOR

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)

Device: extracorporeal shockwave therapy

Conventional Control Group

NO INTERVENTION

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

Interventions

extracorporeal shockwave therapy 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; two thousand pulse ESWT Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28942118 BACKGROUND

• 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.

  PMID: 31415424 BACKGROUND

• 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 BACKGROUND

Related Links

• Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials
• Effect of extracorporeal shockwave therapy on carpal tunnel syndrome: A systematic review and meta-analysis of randomized controlled trials
• Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study

MeSH Terms

Conditions

Carpal Tunnel Syndrome

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• ibrahim Doğru, MD

  Kirsehir Ahi Evran University Physical medicine & rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical medicine and rehabilitation MD

Model Details: three groups with a conventional therapy control group

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: March 20, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)