Clinical trial NCT05314777: Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome
Official title: Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) at Different Pulse Numbers in Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Extracorporeal Shockwave Therapy
Median Neuropathy
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks).

Detailed description: The aim of the study is to examine the effects of ESWT applications at different pulse rates on pain, function, grip strength and median nerve conduction velocity in patients with Carpal Tunnel Syndrome. The sample of the study will consist of patients with carpal tunnel syndrome who were diagnosed in Gaziosmapaşa Training and Research Hospital between April 2022 and December 2022 and whose symptoms have persisted for at least 3 months. The patients will be randomly divided into 3 groups: the low dose ESWT group (28), the high dose ESWT group (28), and the control group (28). The first two groups will receive ESWT treatment at different doses, while the control group will be treated with sound only (1 time/week-3 weeks). The evaluation of the patients participating in the study will be made by the physician who is not aware of the groups. Evaluations will be made 3 times before the treatment, at the 1st month and at the 3rd month. In the evaluation, Boston Carpal Tunnel Syndrome Questionnaire to evaluate symptoms and functionality, visual analog scale (VAS) to evaluate pain, SF-36 to evaluate quality of life, hand dynamometer to evaluate grip strength and electrodiagnostic examination to evaluate median nerve conduction velocity will be performed. After the initial evaluations, the patients participating in the study will be randomly divided into 3 groups. Tendon shifting and nerve shifting exercises will be performed in all groups. ESWT will be applied to 2 groups at different beat numbers. One session of ESWT will be applied to both groups each week for 3 consecutive weeks. In addition to the exercises in the low dose ESWT group, 1000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In addition to the exercises in the high-dose ESWT group, 2000 beats at a pressure of 4 bar and a frequency of 5 Hz will be applied on the ESWT carpal tunnel. In the control group, in addition to the exercises, sham ESWT will be applied. No energy will be used in Sham ESWT application, only sound will be given. Each group will be given a 15-minute cold-pack application after the ESWT application. The exercises will be taught to the patient before the first ESWT application and the exercises will be given to the patients in brochure form. These exercises will be given to the patient as home exercises. You will be asked to do these exercises at home in 2 sets of 5 repetitions 2 times a day. Tendon gliding exercises are performed with the fingers in 5 different positions as regular grip, hook grip, fist, desktop and normal fist. In the distal median nerve gliding exercise, firstly, in the neutral position of the wrist, the fingers and thumb are flexed, in the second position, all the fingers are in the neutral position, in the third position, when the thumb is in the neutral position, the wrist and other fingers are in extension, in the fourth position, the wrist, thumb and other fingers are in extension, In the fifth position, when the wrist and fingers are in the same position, the forearm is in supination, in the sixth position, in the fifth position, the thumb stretching is applied.

Eligibility criteria: Inclusion Criteria:

Being between the ages of 18-65,

* Clinical symptoms persisting for at least 3 months
* Pain, tingling and paresthesia in the first 3 fingers together with the Phalen and Tinel test makes the patient positive,
* Patients who are positive are evaluated by a specialist in electrodiagnostic testing and the clinical stage of CTS is determined.
* Mild to moderate CTS is diagnosed if the sensory nerve action potential (SNAP) is \>6 μV and the combined muscle action potential (CMAP) is \>2.1 mV.
* Being diagnosed with mild and moderate CTS

Exclusion Criteria:

* The patient who received CTS operation or corticosteroid treatment,
* Presence of systemic diseases that will affect our treatment such as diabetes, rheumatoid arthritis, gout,
* It has been determined as atrophy in the thenar region of the hand (Xu,2020).

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: First month- Third month
Secondary outcomes:
measure: Hand Grip Force
timeFrame: First month- Third month
measure: Nerve Conduction Velocity
timeFrame: First month- Third month
measure: Short Form- 36
timeFrame: First month- Third month
measure: Visual analog scale
timeFrame: First month- Third month
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: Beykent University
name: Yasemin Karaaslan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beykent University
name: Fatih Ozyurt, Pt
role: STUDY_CHAIR
References: