Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06206343 |
| Other study ID # |
MCANKAYA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 23, 2023 |
| Est. completion date |
February 23, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Necmettin Erbakan University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Nonspecific chronic neck pain (NCNP) is defined as non-specific neck pain lasting more than
three months. It is a very common disease that causes a great obstacle in the daily life
activities of individuals in the society. Many conservative treatment methods are used in the
treatment of this disease. Among these treatment methods, Transcutaneous Electrical Nerve
Stimulation (TENS) is the most widely used modality due to its low cost and many advantages.
There are 4 types of TENS: Conventional, Low frequency (Acupuncture), Short intensity,
Combined or Burst TENS. Conventional TENS is generally used in the treatment of chronic pain.
Tele-rehabilitation is defined as the delivery of rehabilitation services via online
telecommunication technologies. Tele-rehabilitation overcomes many problems such as long
distance, traffic, transportation difficulties, high cost, high demand in the public health
system, etc. and its popularity is increasing with the developments in technology and
telecommunications. The risks and difficulties of accessing physical treatment during the
COVID-19 pandemic have demonstrated the necessity of Tele-rehabilitation. Therefore,
Tele-rehabilitation is widely used in physiotherapy as well as in many other fields.
Although TENS application is widely used in the treatment of nonspecific chronic neck pain in
physiotherapy clinics, there are few studies on Tele-rehabilitation, there are no studies
comparing their effectiveness compared to each other in this field. In our research, it is
planned to investigate and compare the effectiveness of TENS, which is an easily applied
electrotherapy method, and Tele-Rehabilitation, an online rehabilitation tool. In this study,
the staff of Nezahat Keleşoğlu Faculty of Health Sciences and Seydişehir Vocational School of
Health Services and patients with neck pain who come to the physiotherapy unit of Meram
Medical Faculty Hospital will be included in the study. As a result of the power analysis,
(48) patients are planned to be included.
Patients will be divided into three as Tele-rehabilitation group and TENS group and Control
group. Patients will be evaluated before and after treatment and training.
Description:
Nonspecific chronic neck pain (NCNP) is a highly prevalent disorder that causes a major
impediment to individuals' activities of daily life. It is largely influenced by psychosocial
factors. This disease is defined as pain in the lateral and posterior neck without pathologic
symptoms lasting more than 12 weeks(1). The number of common cases of neck pain worldwide is
estimated to be 288.7 million, and the worldwide prevalence of this disorder (16.7% to 75.1%)
has been reported(2,3).The incidence is higher in women than men (4).
The mechanisms underlying the progression of NKBA are not clear, but it is thought to be
related to impaired proprioception of the neck muscles, which play a decisive role in
cervical joint position and motor control of the head (5). Spinal manipulation, acupuncture,
massage therapy, exercise, traction, soft cervical collar, electrotherapy, yoga and
Tele-rehabilitation are the modalities used in the treatment of this disease (6-14).
One of the most basic applications among these is Transcutaneous electrical nerve stimulation
(TENS). TENS is one of the modalities commonly used to relieve pain in the musculoskeletal
system(4). TENS is the most preferred electroanalgesia method because it is easy to apply,
has few side effects, is relatively safe, non-invasive, low-cost and can be easily applied by
patients at home. TENS provides pain relief through the physiologic pathways of low-voltage
electric current produced by electrodes adhered to the skin. Gate control theory,
hyperstimulation analgesia and endorphin metabolism are used to reduce pain (15,16,17).
Models used in Tens therapy:
- Conventional TENS: It is applied in the form of pulses with high frequency (50-100 Hz)
and low current passage time. It creates a needling and tingling sensation in the
painful area. The effect of conventional TENS starts within 30 minutes and disappears 2
hours after treatment.
- Low frequency (Acupuncture) TENS: produces visible muscle contraction and has a low
frequency (1-5Hz) and high current transit time. Acupuncture TENS increases the release
of endorphins by affecting small diameter C fibers and produces an analgesic effect.
- Short intensity TENS: It is short-intensity and intense, with a frequency of more than
100 Hz and produces pulses of wide width and intensity up to the patient's highest
tolerance. In this model, all sensory and motor fibers are affected. Analgesia effect
starts in 1-15 minutes and disappears in a short time after stimulation.
- Combined or Burst TENS: This model is a combination of high (50-100 Hz) and low (1-10
Hz) frequency currents. Muscle contraction is visible and the analgesic effect starts
later and lasts longer.
The most commonly used models in TENS treatment are conventional TENS and acupuncture TENS
(18,19).Conventional TENS will be applied to the patients in our study.
Tele-rehabilitation is defined as the delivery of rehabilitation services through
telecommunication technologies such as websites, smartphone applications, online video
conferencing systems (20). Tele-rehabilitation is a suitable platform to provide services in
the field of physiotherapy as it is used in many fields.Today, tele-rehabilitation is
increasing in popularity with advances in technology and telecommunications, overcoming some
of the potential barriers to access to health care such as distance, traffic, transportation
difficulties, high cost, high demand in the public health system (long waiting lists), lack
of insurance coverage for private health care (21,22).
The risks and difficulties of accessing physical treatment during the COVID-19 pandemic have
revealed the necessity of tele-rehabilitation(23). Tele-rehabilitation has been used in many
physiotherapy fields such as pediatrics, pneumology, musculoskeletal pain and neurology, but
few studies have examined its effect on neck pain(24).
Despite the widespread use of TENS in the treatment of nonspecific chronic neck pain in
physiotherapy clinics, there have been few studies on Tele-rehabilitation, and there are no
studies comparing their effectiveness compared to each other in this field. In our research,
it is planned to investigate the ethics of TENS, an easy-to-apply electrotherapy method, and
Tele-Rehabilitation, an online rehabilitation tool. Therefore, the aim of the present study
was to investigate the comparative effectiveness of Tele-rehabilitation training or TENS
therapy on pain, functionality and quality of life in patients with NKBA.
Patients who come to Meram Medical Faculty Physical Therapy Unit will be included in this
study. In addition, Necmettin Erbakan University Nezahat Keleoğlu Faculty of Health Sciences,
Kamil Akkanat Faculty of Health Sciences students and employees who have neck pain for more
than 3 months and do not have disc herniation etc. will be included.
