Clinical trial NCT06321276: Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Carpal Tunnel Syndrome
Official title: Investigation of the Efficiency of Radial Extracorporeal Shock Wave Therapy at Different Pulses in Patients With Carpal Tunnel Syndrom a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: rehabilitation
extracorporeal shock wave therapy
physical therapy
Lead sponsor: Ahi Evran University Education and Research Hospital
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three groups with a conventional therapy control group
Primary purpose: TREATMENT

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 0. week , 4. week , 12. week
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 0. week, 4. week , 12. week
Secondary outcomes:
measure: Hand grip strength measurement
timeFrame: 0. week, 4. week, 12. week
measure: Electromyoneurography (EMNG)
timeFrame: 0. week, 12. week
measure: Ultrasonography
timeFrame: 0. week, 12. week
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
affiliation: Kirsehir Ahi Evran University Physical medicine & rehabilitation
name: ibrahim Doğru, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.