Clinical trial NCT06818422: Telemedicine for Nonspecific Neck Pain
Official title: Comparison of Telemedicine and Conventional Monitoring Methods in Nonspecific Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Exercise
Telemedicine
Keywords: neck pain
home exercise
telemedicine
teleexercise
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Brief Summary

Neck pain is a common global health issue, often classified as nonspecific neck pain when no specific cause is identified. Neck pain is a common global health issue, often classified as non-specific neck pain when no specific cause is identified. This study aims to compare the effectiveness of telemedicine (which involves providing home exercises and recommendations through pre-recorded exercise videos and remote follow-up) versus conventional care (which involves demonstrating home exercises, providing informational brochures, and conducting in-person follow-ups) for patients with nonspecific neck pain. Participants will be randomly assigned to either group. The primary outcomes are pain intensity (VAS) and neck function (NDI), with secondary outcomes including exercise adherence, patient satisfaction, and healthcare costs.

The study hypothesizes that telemedicine will result in greater pain reduction, improved neck function, and higher patient satisfaction due to the convenience and accessibility of video-based exercises. If proven effective, telemedicine could reduce hospital crowding, minimize infection risks, save time and money, and reduce environmental impacts, making it a valuable tool in non-serious pathologies and during events like pandemics.

Detailed description: Neck pain is a very common public health problem worldwide. It is defined as pain perceived between the upper nuchal line and the spinous process of the first thoracic vertebra. This pain can sometimes be reflected to the head, trunk and upper extremities. Nonspecific neck pain refers to neck pain for which no specific cause or underlying disease can be identified. It is generally used to refer to neck pain that cannot be attributed to conditions such as infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder or radicular symptoms. Although many interventions have been recommended for neck pain in the American Physical Therapy Association (APTA) clinical practice guideline, the only interventions recommended based on strong evidence are coordination, strengthening, endurance exercises, cervical mobilization/manipulation and patient education. Other interventions are based on weak or moderate evidence. In neck pain syndromes, exercise therapy is primarily recommended for neck pain without signs of major structural pathology. In fact, exercise therapy has surpassed physical therapy modalities compared to the past. While exercise, mobilization, and manipulation treatments for non-specific neck pain have the greatest support in the literature, there is little evidence for the effectiveness of thermal treatments and electrical therapies, with no evidence of more than a temporary benefit.

This study aims to compare the telemedicine method, in which asynchronous exercise videos (tele-exercise) and educational videos containing recommendations (tele-education) are sent to patients' phones, and patients are followed up by physicians via remote video calls (tele-consultation), with the conventional follow-up method, in which patients are given a brochure containing the same exercises and recommendations, and patients are followed up by physicians via face-to-face meetings in the hospital.

Participants will consist of patients diagnosed with non-specific neck pain. Patients will be randomly assigned to one of two groups: Group A (Telemedicine Group) and Group B (Conventional Follow-up Group). The study content will be explained to the patients on the first day at the hospital and they will be asked to sign a voluntary consent form. Patients in Group A will receive a pre-recorded neck exercise video and an educational video sent to their phones by the physician. These patients will exercise at home three times a day for 2 weeks. They will mark the exercise diary provided to them when they do their exercises. They will have remote check-ups via video call every two weeks (on the 15th and 30th days) to monitor pain intensity and provide support. Patients in Group B will receive an exercise brochure and an educational brochure provided by the physician in person at the clinic. These patients will also exercise at home three times a day for 2 weeks. They will mark the exercise diary provided to them when they do their exercises. They will have clinical check-ups every two weeks (on the 15th and 30th days) to monitor pain intensity and provide support. The primary outcome measures are pain intensity measured using the Visual Analog Scale (VAS) and neck function assessed using the Neck Disability Index (NDI). Secondary outcome measures are adherence to the exercise program monitored through an exercise diary, patient satisfaction assessed on a Likert scale from 0 to 5, and total money spent on follow-up visits (transportation expenses, healthcare expenses) and time (time spent on the road, hospital waiting time) for Group B.

VAS and NDI will be measured initially for both groups through face-to-face assessments. In 15th day, VAS and NDI will be administered through video interviews (Group A) and face-to-face assessments (Group B). In addition, completed exercise diaries will be collected via WhatsApp (Group A) or clinic visits (Group B), and total money and time spent on transportation will be calculated for Group B. In day 30, VAS, NDI, and patient satisfaction will be assessed through video interviews (Group A) and face-to-face assessments (Group B).

Participants will be unaware of the procedures used in the other group and the outcome assessor will be blinded to group assignments during the statistical analysis to prevent bias. Adherence will be monitored through exercise diaries and qualitative feedback will be collected through surveys or interviews to understand patient experiences and compliance difficulties. Sample size will be determined based on power analysis.

The primary hypothesis (H1) is that Group A will show greater improvement in pain reduction and neck function than Group B due to the more accurate implementation of video exercises and advice than visual exercises and advice. The secondary hypothesis (H2) is that Group A will show higher adherence and satisfaction due to the ease of video-based exercises and the lack of a hospital visit.

This study will be the first scientific study to compare the telemedicine method with the conventional method. If the telemedicine method demonstrates an equivalent or superior efficacy to the conventional method, If the telemedicine method shows an effectiveness equal to or superior to the conventional method and this method is widely used in the future, this will provide great convenience for both clinicians and patients, reduce the density in hospital polyclinics and reduce the risk of contamination in healthcare areas. Telemedicine applications that can be performed remotely in diseases that do not involve serious pathology provide significant advantages to both individuals and health insurance systems in terms of time (time spent on the road, waiting time in the hospital, etc.) and financial expenses (transportation and healthcare expenses, etc.). In addition, these methods reduce air pollution by reducing traffic density and gasoline consumption, thus minimizing environmental impacts. The spread of telemedicine applications also stands out as an effective medical option in unexpected quarantine conditions such as pandemics.

Eligibility criteria: Inclusion Criteria:

* Non-specific neck pain (neck pain without a specific underlying cause such as infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder or radicular symptoms)
* Clinical and/or radiological presence of one of the following diagnoses: cervicalgia, cervical flattening, cervical arthrosis, cervical discopathy
* Able to understand and apply the given exercises; literate and therefore able to read and interpret the given brochure; familiar with smartphones, tablets and computers, able to use them easily, able to open and watch sent videos, have internet access

Exclusion Criteria:

* Having a cognitive disorder
* Red flag findings indicating serious pathology, recent trauma to the neck region, fracture, lysis, listhesis, spinal mass and malignancy, syringomyelia, presence of canal stenosis
* Having undergone surgery in the cervical region
* Having received injections to the neck and back region in the last 3 months
* Having received physical therapy or home exercise recommendations in the same hospital or in another center in the last 3 months
* Not having their own smartphone or smart tablet and/or uninterrupted internet access
* Having a visual impairment
* Having an upper extremity amputation
* Having advanced cancer, receiving cancer treatment
* Having complicated diabetes

Primary outcomes:
measure: Pain intensity
timeFrame: 15th day and 30th day
measure: Neck function
timeFrame: 15th day and 30th day
Secondary outcomes:
measure: Adherence to the exercise program
timeFrame: 15th day
measure: Patient satisfaction
timeFrame: 30th day
measure: Transportation expenses
timeFrame: 30th day
measure: The time spent
timeFrame: 30th day
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Selkin Yılmaz Muluk
city: Antalya
country: Turkey
facility: Antalya City Hospital
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital, Antalya City Hospital
name: Selkin Yılmaz Muluk, MD
role: PRINCIPAL_INVESTIGATOR
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