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Status unknownNCT05314777Updated Jun 2, 2022

Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome

An interventional study of Low dose ESWT application and High dose ESWT application in Carpal Tunnel Syndrome, sponsored by University of Beykent. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by University of Beykent · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Carpal Tunnel Syndrome

Keywords

  • Carpal Tunnel Syndrome
  • Extracorporeal Shockwave Therapy
  • Median Neuropathy
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

University of Beykent is the lead sponsor of 54 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Low dose ESWT application group

    Exercise Training Low dose ESWT application

    Procedure: Low dose ESWT application · Procedure: Exercise Training

  • Experimental
    High dose ESWT group

    Exercise Training High dose ESWT application

    Procedure: High dose ESWT application · Procedure: Exercise Training

  • Active comparator
    Control group

    Exercise Training Sham ESWT

    Procedure: Sham ESWT · Procedure: Exercise Training

Interventions

  • ProcedureLow dose ESWT application

    Patients trained for low dose ESWT application.

  • ProcedureHigh dose ESWT application

    Patients trained for high dose ESWT application.

  • ProcedureSham ESWT

    Patients trained for sham ESWT.

  • ProcedureExercise Training

    Patients trained for exercise training.

06

What researchers measure

Primary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire

    The boston carpal tunnel syndrome questionnaire will be used to measure the severity of the disease and the level of functionality.

    Time frame: First month- Third month

Secondary outcomes

  1. Hand Grip Force

    Hand grip strength will be measured with a Jamar dynamometer.

    Time frame: First month- Third month

  2. Nerve Conduction Velocity

    The conduction velocity of the median nerve will be measured according to the American Academy of Neurology

    Time frame: First month- Third month

  3. Short Form- 36

    The quality of life of the patients will be evaluated with short form 36.

    Time frame: First month- Third month

  4. Visual analog scale

    The pain intensity felt by the participants during rest and activity, respectively, will be evaluated by VAS

    Time frame: First month- Third month

07

Study locations

1 of 1 sites recruiting
  • Gaziosmanpasa Training and Research Hospital
    İstanbul, 34488, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05314777
Lead sponsor
University of Beykent
Responsible party
Yasemin Karaaslan (Ph.D. Pt., University of Beykent) — Principal investigator
First posted
Apr 6, 2022
Start date
May 30, 2022
Primary completion
Aug 20, 2022 (estimated)
Completion
Dec 20, 2022 (estimated)
Last update
Jun 2, 2022

Study contacts

Yasemin Karaaslan, Ph.D.
Contact
ptyasemindeveci@gmail.com
05358459625
Yasemin Karaaslan, Ph.D.
principal investigator · Beykent University
Fatih Ozyurt, Pt
study chair · Beykent University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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