Clinical trial NCT06206343: Telerehabilitation With Transcutaneous Electrical Nerve Stimulation Chronic Neck Pain:
Official title: Comparison of the Effectiveness of Telerehabilitation With Transcutaneous Electrical Nerve Stimulation on Pain and Functionality in Individuals With Chronic Neck Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Telerehabilitation
Transcutaneous Electrical Nerve Stimulation
Pain
Keywords: Neck Pains
Tele-rehabilitation
Transcutaneous Electric Stimulation,
Chronic Pain
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Posttest and control grouped randomized controlled clinical trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being between 18-55 years old
* People with non-specific neck pain, defined as pain not attributed to a cause
* Neck pain that has persisted for at least three months and recurs more than 1 time,
* Agreeing to participate in the study,
* To be able to read and write Turkish
* Have a computer, tablet or smartphone and an active internet connection,
* Having at least 2 points of pain according to the Visual Analog Scale at rest, and having a score of 10 and above according to the Neck Disability Index,
* Being able to use a computer, tablet and the internet at a level to participate in video conferencing or having a relative who can help in this regard (10,23,25,27)

Exclusion Criteria:

Spinal surgery history

* Traumatic cervical injuries
* Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
* Cervical region fractures
* Tumoral conditions
* Having vision and hearing problems
* Cognitive influences
* People with skin allergies
* Scleroderma, vasculitis or neuropathic pathologies
* People with pacemakers
* Pregnant women (10,23,25)

Primary outcomes:
measure: Bournemouth neck pain questionnaire
timeFrame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total.
measure: Neck Disability Index (NDI)
timeFrame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
measure: Copenhagen Neck Functional Disability Scale (CNFDS)
timeFrame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
measure: World Health Organization Quality of Life Module (WHOQOL-BREF)
timeFrame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Musa Çankaya
Study officials:
affiliation: Necmettin Erbakan University
name: Musa Çankaya, Pt.PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmetin Erbakan University, MeramFacultyofMedicine
name: Sami Küçükşen, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Necmettin Erbakan University
name: PARİYA POURİYAMANESH, Int.Pt
role: PRINCIPAL_INVESTIGATOR
References: