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Carpal Tunnel SyndromeNCT05314777

Efficacy of Extracorporeal Shock Wave Therapy in Carpal Tunnel Syndrome

A study testing Low dose ESWT application, High dose ESWT application and Exercise Training in people with Carpal Tunnel Syndrome, run by University of Beykent at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Low dose ESWT application, High dose ESWT application and Exercise Training
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 May 2022to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Yasemin Karaaslan, Ph.D. contact

05358459625

ptyasemindeveci@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Gaziosmanpasa Training and Research Hospital

    Istanbul, 34488

    Yasemin Karaaslan, ptyasemindeveci@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) at Different Pulse Numbers in Carpal Tunnel Syndrome

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.

Being tested
Low dose ESWT application, High dose ESWT application, Sham ESWT, Exercise Training
Keywords
Carpal Tunnel Syndrome, Extracorporeal Shockwave Therapy, Median Neuropathy
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low dose ESWT applicationProcedure or surgery

    Patients trained for low dose ESWT application.

  • High dose ESWT applicationProcedure or surgery

    Patients trained for high dose ESWT application.

  • Sham ESWTProcedure or surgery

    Patients trained for sham ESWT.

  • Exercise TrainingProcedure or surgery

    Patients trained for exercise training.

Study groups in NCT05314777
Study groupRoleWhat they receive
Low dose ESWT application groupExperimentalExercise Training Low dose ESWT application
Receives: Procedure: Low dose ESWT application; Procedure: Exercise Training
High dose ESWT groupExperimentalExercise Training High dose ESWT application
Receives: Procedure: High dose ESWT application; Procedure: Exercise Training
Control groupActive comparatorExercise Training Sham ESWT
Receives: Procedure: Sham ESWT; Procedure: Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: First month- Third month

Secondary outcomes (4)
  1. Hand Grip Force

    Hand grip strength will be measured with a Jamar dynamometer.

    Measured: 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

    Measured: First month- Third month

  3. Short Form- 36

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

    Measured: 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

    Measured: First month- Third month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start30 May 2022
  3. Primary completion20 Aug 2022 (estimated)
  4. Study completion20 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314777
Sponsor's protocol ID
02032022
Status last verified
May 2022
First submitted
29 Mar 2022
Last updated
2 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Low dose ESWT application, High dose ESWT application and Exercise Training in people with Carpal Tunnel Syndrome, run by University of Beykent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yasemin Karaaslan, Ph.D. (05358459625, ptyasemindeveci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston Carpal Tunnel Syndrome Questionnaire (time frame: First month- Third month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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