Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05681663 |
| Other study ID # |
43834581758 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Ahi Evran University Education and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Peripheral nerve entrapment neuropathies are the most common mononeuropathies in clinical
practice. Carpal Tunnel Syndrome (CTS), n. It occurs as a result of compression of the
medianus as it passes through the carpal tunnel, a narrow osteofibrous canal. CTS is the most
common entrapment neuropathy of the upper extremity, affecting approximately 3% of the
general adult population.
This study, which was designed as a randomized controlled study, will include 36 patients
with CTS, aged between 18-65, who applied to Kırşehir Ahi Evran University Training and
Research Hospital. In our study, both groups will be given 10 minutes of paraffin, 20 minutes
of TENS, and 10 repetitions of tendon gliding exercise, 3 days a week for a total of 3 weeks
(9 sessions). EESDT will be applied once a week in both groups (one group at 4 bar and the
other at 1.5 bar pressure). Measurements will be made before treatment, after treatment, and
at 12 weeks post-treatment.
In the literature, different pressure parameters were used in studies examining the efficacy
of ESDT in the treatment of CTS. Although ESDT has been shown to have a curative effect on
CTS, there is no consensus on which pressure parameter is more effective. Therefore, in this
study, the effectiveness of ESDT applied at different pressure parameters in the treatment of
CTS will be examined.
Description:
Compression of peripheral nerves in fibroosseous tunnels located at segmental passages in the
body is called entrapment neuropathy. In this type of neuropathies, the peripheral nerve is
exposed to a neuropraxia-type injury in the area where it is compressed (1, 2). As a result,
a picture develops in the distal part of the injured area, which leads to long-term motor,
sensory and autonomic pathologies, and reduces the quality of life and functionality (3).
Carpal Tunnel Syndrome (CTS) occurs when the median nerve is exposed to compression during
its passage through the carpal tunnel (4). Although CTS is the most common impingement
neuropathy in the upper extremity, it has been reported to affect approximately 3% of the
adult population (5). Although the incidence of CTS in women is three times higher than in
men, the prevalence and severity increase with age. Work-related activities that require
high-frequency repetition and force or the use of hand-operated vibrating tools significantly
increase the risk of CTS (6).
CTS symptoms are generally characterized by pain and paresthesia in the innervation area of
the median nerve in the hand region. Although these symptoms vary, they can sometimes be seen
in the entire hand, rarely in the forearm and shoulder region. Repetitive wrist movements
such as driving a vehicle, doing repetitive work with hand tools, squeezing diapers, and
opening jars are activities that provoke the existing pathology. Patients generally report
that their complaints decrease when they hold their hands down and shake them. This condition
is known clinically as the Flick Sign and is 93% sensitive and 96% specific for CTS (7). As
the anatomical localization within the carpal tunnel, the sensory fibers are subjected to
compression before compared to the motor fibers, and only pain and paresthesia are seen in
acute CTS. In severe cases where motor fibers are also affected, muscle weakness
characterized by thumb abduction and oposition weakness is added to the present picture (8).
There are two different treatment options in CTS, conservative and surgical. In the
conservative treatment of CTS; Conservative treatment methods such as local steroid
injection, nonsteroidal anti-inflammatory drugs, diuretics, pyridoxine, splint, daily living
activities, tendon-nerve slide exercises, manipulation, physical therapy, acupuncture,
vitamin B6 are used. The approach in surgical treatment is surgical decompression and it is
performed to relax the median nerve by loosening the transverse carpal ligament (9).
Eisenmenger defined the physical properties of extracorporeal shock wave therapy (ESDT) for
the first time in 1959 and stated that high-intensity sound waves are applied to the body in
the EIST treatment method (10). Shock waves were first applied to break up kidney stones in
the 1980s. As the changes in the ilium were noticed while breaking the lower ureteral stones,
studies were also started on bone tissues. Since 1990, research has been carried out on the
use of this method in orthopedic diseases (11). ESDT has recently been widely used by
orthopedists in Europe and the interest in its application has increased, and thousands of
patients are treated with this method in the world (12).
Shock waves are caused by sudden changes in pressure, and these changes in pressure create
strong waves that cause tension and compression. Shock wave is defined as acoustic wave. In
sinusoidal shock waves, the pressure rises rapidly with a positive pressure (100-1000 bar) in
as little as a few nanoseconds (ns) (less than 1 microsecond), followed by a rapid decrease
and negative pressure.
The phase time of the wave is very short, the phase duration is defined in an average of 10
milliseconds (ms). Its frequency ranges from 16 hertz (Hz) to 20 megahertz (MHz). In this
way, the energy is broken and reflected as it passes through areas such as bone and soft
tissue, and the resulting kinetic energy affects the tissues. With the energy of the shock
wave, cavitation occurs in the tissue and a force such as pressure and fragmentation occurs.
Absorption of shock waves into the tissue is provided by conductive gels (11, 13).
In one study, a systematic review and analysis of randomized controlled trials was conducted
on the effect of ESDT on CTS. In this study, 6 randomized controlled trials were examined. In
conclusion, this meta-analysis revealed that ESDT can improve symptoms, functional outcomes
and electrophysiological parameters in patients with CTS (10). In the literature, different
pressure parameters have been used in studies examining the effectiveness of ESDT in the
treatment of CTS (14,15,16). Although ESDT has been shown to have a curative effect on CTS
(17), there is no consensus on which pressure parameter is more effective. Therefore, in this
study, the effectiveness of ESDT applied at different pressure parameters in the treatment of
CTS will be examined.
