Telerehabilitation With Transcutaneous Electrical Nerve Stimulation Chronic Neck Pain:

NCT06206343 | Completed DMC

• 1 other identifier: MCANKAYA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain; Telerehabilitation; Transcutaneous Electrical Nerve Stimulation; Pain

Keywords

Neck Pains; Tele-rehabilitation; Transcutaneous Electric Stimulation,; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• Bournemouth neck pain questionnaire

  This questionnaire consists of 7 questions in total. Developed in 2002 in the UK. It includes questions about pain, disability and psychosocial issues (33). Each question is scored between 0 and 10. The highest score is 70 and the closer the score is to 70, the higher the patient's level of disability. The content of the questionnaire consists of variables such as pain severity, the effect of pain on activities of daily living and social life, anxiety-depression level, kinesiophobia and coping with pain. The Turkish version of the questionnaire was conducted by Telci et al. (34).

  valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total.

• Neck Disability Index (NDI)

  The NDI was designed by Vernon and Mion to assess how neck pain affects functionality related to activities of daily living (42). In a 3-year prospective study conducted for the prediction of long-term health problems after neck injury, only the NDI was associated with true significance. Furthermore, in cross-cultural studies conducted in French, Swedish (albeit modified), Portuguese and Dutch, the NDI has proven to be a valid and reliable tool for measuring disability (43). The Turkish validity and reliability of the scale was conducted by Aslan et al. (2009) (44,45).

  valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total

• Copenhagen Neck Functional Disability Scale (CNFDS)

  It is a scale completed by the patient. It was developed in 1998 by Jordan. The questionnaire consisting of 15 questions evaluates the severity of pain, activities of daily living, social and recreational activities, and the future status of neck pain.Questions 1, 2, and 3 in this questionnaire evaluate attention; questions 4 and 5 evaluate proprioceptive sensation; questions 6, 7, and 9 evaluate the perception of neck shape and size; and question 8 evaluates neglect.The total score in this questionnaire varies between 0-30, and an increase in score indicates an increase in the level of disability (35, 36).

  valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total

• World Health Organization Quality of Life Module (WHOQOL-BREF)

  WHOQOL, a general purpose quality of life profile scale, has two versions, long and short. The health-related quality of life scale was developed by WHO and its validity and reliability was performed by Eser et al. The scale has two versions, long (WHOQOL-100) and short (WHOQOL-27). The scale measures physical, mental, social and environmental well-being and consists of 26 questions (37). The scale can be applied to non-elderly adults. The scale has also been applied to healthcare professionals. Since each domain independently expresses the quality of life in its own domain, domain scores are calculated between 4-20. The higher the score, the better the quality of life (38).

  valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total

Study Arms (3)

TENS application treatment program

EXPERIMENTAL

Conventional TENS will be performed for 3 weeks and 15 sessions. In this application, two electrodes will be placed on each side of the spinous processes of the patient's cervical region. Two of them will be placed right and left, just below the skull, where the scalp ends, and the other two will follow them, about 5 cm away. Care will be taken not to place the electrodes directly on your spine.

Other: TENS application, Tele-rehabilitation treatment program

Tele-rehabilitation application treatment program:

EXPERIMENTAL

Patients who accept the treatment will be evaluated before treatment. The treatment program will be done online for 3 weeks, 3 times a week. In the first session, neck anatomy and things to be considered in neck pain will be explained to the patient. In the following sessions, neck exercises will be performed with the participation of the patients. Neck exercises: 1.Head rotation movements 2.Chin tuck 3.Neck isometric exercises 4.Shoulder shrug 5.Scapula approach 6.Isometric strengthening 7.Exercises against gravity 8.Stretching exercises etc. will be done.

Other: TENS application, Tele-rehabilitation treatment program

Control group

NO INTERVENTION

Control group patients will not receive any treatment. The first evaluation was done. After 3 weeks, the second evaluation will be done again.

Interventions

TENS application, Tele-rehabilitation treatment program OTHER

Exercise training

Also known as: Exercise training:

TENS application treatment program; Tele-rehabilitation application treatment program:

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Musa Çankaya

Konya, 42100, Turkey (Türkiye)

Location

Related Publications (1)

• Cankaya M, PourIYamanesh P, Kucuksen S. Investigation of the effectiveness of interactive telerehabilitation and transcutaneous electrical nerve stimulation on pain, functionality, disability and quality of life in patients with nonspecific chronic neck pain: a randomised controlled trial. Expert Rev Med Devices. 2025 Mar;22(3):243-252. doi: 10.1080/17434440.2025.2471444. Epub 2025 Feb 26.

  PMID: 39988923 DERIVED

MeSH Terms

Conditions

Pain; Neck Pain; Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Musa Çankaya, Pt.PhD.

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

• Sami Küçükşen, Prof.Dr.

  Necmetin Erbakan University, MeramFacultyofMedicine

  PRINCIPAL INVESTIGATOR

• PARİYA POURİYAMANESH, Int.Pt

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 45
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Doctor

Model Details: Posttest and control grouped randomized controlled clinical trial.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: April 7, 2024
• Primary Completion: June 1, 2024
• Study Completion: August 10, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

TU (1)