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Carpal Tunnel SyndromeESWTNCT04896398

The Effect of ESWT in Carpal Tunnel Syndrome

A study testing ESWT in people with Carpal Tunnel Syndrome, run by Istanbul University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

50 patients who meet the inclusion criteria will be included in this prospective, randomized and controlled study. Demographic information of the patients will be taken and recorded. 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?
ESWT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2021to 1 Nov 2021
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

  • Patients with a diagnosis of mild to moderate CTS in the nerve conduction study within the last 1 month,
  • Positive Phalen and Tinnel tests in clinical examination
  • Who agreed to participate in the study

Who cannot join

  • Patients with cervical radiculopathy,
  • Pregnant women,
  • Rheumatoid arthritis,
  • Thenar atrophy,
  • Steroid injection or surgical procedure in the wrist in the last 3 months.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahmet Kıvanç Menekşeoğlu

    Istanbul, 34015

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome

50 patients who meet the inclusion criteria will be included in this prospective, randomized and controlled study. Demographic information of the patients will be taken and recorded. After the patients are numbered according to the order of application, they will be divided into 2 groups as study and control groups according to randomization with the computer program. A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the study group (1st group) for 2 weeks. Patients will be taught median nerve and tendon shifting exercises and will be asked to do it regularly. Patients in the control group (Group 2) will be asked to perform median nerve and tendon shifting exercises only for the wrist. Patients will be evaluated before treatment, at 4 and 12 weeks after treatment. In the evaluation, Boston Carpal Tunnel Inquiry Form, pain severity assessment with VAS (visual analog scale), neuropathic pain intensity with LANSS scale and median nerve conduction velocity with EMG will be evaluated.

Read the detailed description

Carpal tunnel syndrome is a clinical picture that occurs with a group of symptoms and signs as a result of compression and compression in the carpal tunnel where the median nerve passes to the wrist. Another name is hand-wrist canal disease, the most common entrapment is neuropathy. It is generally observed in individuals between the ages of 40-60, its prevalence is 4-5%, and it is 3 times more common in women than men. Clinical signs 1.-2.-3. numbness, tingling, abduction and positioning of the thumb, pain in the wrist and inner part of the hand, autonomic symptoms (heat or discoloration, dry skin) worsening of symptoms due to provocative factors (forcing the wrist to flex). Loss of strength and atrophy of the palm muscles occur in the later stages. The diagnosis is made by clinical examination, electrophysiological methods (EMG) and imaging methods (such as ultrasound, magnetic resonance imaging). Clinical examination consists of sensory motor examination and provocative tests. Treatment is divided into conservative and surgical. Among the conservative treatment methods, splinting, exercise (sliding movements of the median nerve and wrist flexor tendons in the wrist), local corticosteroid injection (corticosteroid injection into the carpal tunnel), ultrasound (warming the deep tissues with sound energy), TENS (electrodes placed on the skin). pain relief by applying controlled low-voltage electric current to the nervous system through the skin), paraffin bath (immersion of the hand in a pool of heat-melted paraffin), ergonomic arrangements. ESWT is a widely used treatment method in the treatment of carpal tunnel syndrome in recent years. ESWT is called "Extracorporeal Shock Wave Therapy", in Turkish "Shock Wave Therapy Applied Outside the Body" or simply "Shock Wave Therapy". It is a treatment method based on the principle of focusing the shock (pressure) waves created outside the body to the desired area of the body by means of a steel-headed applicator. Shock waves are single pulsatile acoustic waves of high amplitude. It reaches high pressure (100Mpa) and then negative pressure (5-10 Mpa) in a short time expressed in nanoseconds (10 ns). This device was first applied in the destruction of urinary stones in the 1980s. In the following years, it has been used in cases such as shoulder calcific tendinitis, lateral epicondylitis, plantar fasciitis, and fracture healing. Currently indications for ESWT are non-union fractures, revision arthroplasties, lateral epicondylitis, plantar fascitis, calcified tendinitis of the shoulder, avascular necrosis of the femoral head, Achilles tendinitis, patellar tendinitis, myofascial pain syndrome, ischemic heart disease, peyronia disease, chronic diabetic heart disease. It covers a wide range of disease groups such as ulcers, knee osteoarthritis, complex regional pain syndrome, carpal tunnel syndrome. Studies have shown that ESWT increases angiogenesis, neovascularization, anti-inflammatory growth factor release, progenitor and stem cell activation. Morphological changes were detected in cutaneous sensory nerve fibers with shock wave application on the nerves. It has been observed that there is a relationship between reduction of PGP 9.5 (protein gene product) and CGRP (calcitonin gene-related peptide) and pain reduction following shock application in sensory nerve fibers in the epidermal region. At the same time, integrin molecules are secreted for axonal growth with shock application and this continues cumulatively with ESWT application. GAP 43 (growth associated phosphoprotein) molecule, which is a marker related to axonal regeneration and which is highly expressed especially during neuron development and axonal 3/10 elongation, has been found to increase after ESWT application. In this study, it was aimed to investigate the effectiveness of ESWT treatment applied to patients diagnosed with mild to moderate carpal tunnel syndrome by EMG.

Being tested
ESWT
Keywords
ESWT
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

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

  • ESWTDevice

    In the study group, a total of 5 sessions of focused ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the affected wrist within 2 weeks.

Study groups in NCT04896398
Study groupRoleWhat they receive
ESWT GroupExperimentalA total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the patients in this group for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly.
Receives: Device: ESWT
Control GroupNo interventionPatients in the control group will be asked to do median nerve and tendon shifting exercises only for the wrist.

What is being measured

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

  1. Boston carpal tunnel questionnaire

    The functional levels of the patients will be evaluated with the Boston carpal tunnel questionnaire.

    Measured: 3 months

Secondary outcomes (2)
  1. Visual Analog Scale

    The pain level of the patients will be evaluated with visual analog scale. The visual analog scale is scored between 0 and 10. Increased scores mean more pain.

    Measured: 3 months

  2. Median nerve conduction study

    Median nerve conduction velocity will be evaluated by ENMG.

    Measured: 3 months

Timeline

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

  1. First posted21 May 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Sep 2021
  4. Study completion1 Nov 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After the patients are numbered according to the order of application, they will be divided into 2 groups as study and control groups according to randomization made with the computer program (block randomization). A total of 5 sessions of ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the study group (1st group) for 2 weeks. Median nerve and tendon shifting exercises will be taught to the patients and they will be asked to do it regularly. Patients in the control group (Group 2) will be asked to perform median nerve and tendon shifting exercises only for the wrist. Patients will be evaluated before treatment and at 4 and 12 weeks after treatment.
Masking
Single blind
Who is masked
Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04896398
Sponsor's protocol ID
2021-1
Acronym
ESWT
Status last verified
Mar 2023
First submitted
13 May 2021
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Identity information of the patients other than their gender, age and BMI will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing ESWT in people with Carpal Tunnel Syndrome, run by Istanbul University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Mar 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Boston carpal tunnel questionnaire (time frame: 3 months). 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 20 Mar 2023.

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