Chronic Neck PainNCT06206343
Telerehabilitation With Transcutaneous Electrical Nerve Stimulation Chronic Neck Pain:
A study testing TENS application, Tele-rehabilitation treatment program in people with Chronic Neck Pain and Telerehabilitation, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain, Telerehabilitation, Transcutaneous Electrical Nerve Stimulation
- What is being tested?
- TENS application, Tele-rehabilitation treatment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2024to 10 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Spinal surgery history
- Traumatic cervical injuries
- Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
- Cervical region fractures
- Tumoral conditions
- Having vision and hearing problems
Show all 11Show fewer
- Cognitive influences
- People with skin allergies
- Scleroderma, vasculitis or neuropathic pathologies
- People with pacemakers
- Pregnant women (10,23,25)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- TENS application, Tele-rehabilitation treatment program
- Keywords
- Neck Pains, Tele-rehabilitation, Transcutaneous Electric Stimulation,, Chronic Pain
- Medical subject headings
- Pain, Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS application, Tele-rehabilitation treatment programOther
Also called Exercise training:
Exercise training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start7 Apr 2024
- Primary completion1 Jun 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Posttest and control grouped randomized controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUSA ÇANKAYA, Necmettin Erbakan University
- Investigators
- Musa Çankaya, Pt.PhD., Principal investigator, Necmettin Erbakan UniversitySami Küçükşen, Prof.Dr., Principal investigator, Necmetin Erbakan University, MeramFacultyofMedicinePARİYA POURİYAMANESH, Int.Pt, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206343
- Sponsor's protocol ID
- MCANKAYA
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39988923
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06206343
- Acronym / sponsor ID
- MCANKAYA
- Keywords
- Neck Pains, Tele-rehabilitation, Transcutaneous Electric Stimulation,, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Posttest and control grouped randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| TENS application treatment program | Experimental | Other: TENS application, Tele-rehabilitation treatment programConventional 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. |
| Tele-rehabilitation application treatment program: | Experimental | Other: TENS application, Tele-rehabilitation treatment programPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- Spinal surgery history
- Traumatic cervical injuries
- Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
- Cervical region fractures
- Tumoral conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS application, Tele-rehabilitation treatment programAlso: Exercise training:Exercise training | Other | TENS application treatment program, Tele-rehabilitation application treatment program: |
Primary outcome
Bournemouth neck pain questionnaire
Time frame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total.
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).
Neck Disability Index (NDI)
Time frame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
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).
Copenhagen Neck Functional Disability Scale (CNFDS)
Time frame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
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).
World Health Organization Quality of Life Module (WHOQOL-BREF)
Time frame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Derived from this study: PubMed 39988923Cankaya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Musa Çankaya, Pt.PhD. principal investigator
Necmettin Erbakan University
Sami Küçükşen, Prof.Dr. principal investigator
Necmetin Erbakan University, MeramFacultyofMedicine
PARİYA POURİYAMANESH, Int.Pt principal investigator
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS application, Tele-rehabilitation treatment program in people with Chronic Neck Pain and Telerehabilitation, run by Necmettin Erbakan 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 8 inclusion and 11 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 23 Jan 2025. 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?
Bournemouth neck pain questionnaire (time frame: valuation will be made before and after treatment. The evaluation is expected to take 10 minutes in total.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06206343, which also lists 1 linked publication.
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 23 Jan 2025.