Clinical trial NCT06632028: Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation
Official title: THE EFFECT OF ARTIFICIAL INTELLIGENCE ASSISTED SPINE REHABILITATION ON GENERAL HEALTH, ANXIETY AND DISABILITY IN PATIENTS WITH CERVICAL DISC HERNIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herniated Intervertebral Disc
Keywords: cervical disc herniation
artificial intelligence assisted spinal rehabilitation
traditional physiotherapy
pain
general health
Anxiety
disability
herniated intervertebral disc
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In total, two different groups will be treated. One group will receive spinal rehabilitation supported by artificial intelligence, while the other group will receive traditional physiotherapy applications.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of artificial intelligence-assisted spinal rehabilitation in neck hernia compared to traditional methods.

Detailed description: Cervical disc herniation is the displacement of the intervertebral disc or nucleus pulposus in the direction of the cervical spinal canal and the resulting clinical picture. Cervical disc herniation occurs especially after the age of 40 years with disc degeneration and deterioration of the natural structure of bones and joints . Symptoms vary depending on the affected level, size and localisation of the herniation (central, lateral or foraminal). Radiculopathy accompanied by neck pain, pain radiating to the arm, paresthesia and sensory, motor and reflex changes are frequently observed . Neck pain and stiffness may radiate to the shoulder and arm. The most common complaint is neck pain, followed by paresthesia, radicular pain and weakness. It has been reported that pain originating from C6-C7 is felt in the lower part of the scapula, while pain originating from C5-C6 is felt in the middle of the medial scapula. Pain originating from C4-C5 is felt around the spine and superior to the scapula, and pain originating from C3-C4 is felt at the spinous process of the C7 vertebra and the posterior edge of the trapezius muscle. In physical examination of individuals with cervical pain due to cervical disc herniation, differences were found in ROM values, muscle strength test results, postural evaluation data, quality of life and depression levels and functional level of the neck compared to normal individuals. In cervical disc herniation, non-invasive physical therapy applications such as laser treatment, hot-cold treatment methods, Transcutaneous Electrical Nerve Stimulation (TENS), interferential currents, manual therapy applications, kinesiological taping and exercise therapy as well as painkillers and nonsteroidal anti-inflammatory drugs and antidepressive drugs are the most preferred methods in treatment. Cervical disc herniation may cause pain and various neurological deficits due to biochemical, vascular and anatomical changes in the intervertebral disc, which are influenced by extrinsic, intrinsic and genetic factors, and which occur especially as a result of exposure of the cervical region to mechanical stress. Neck pain can often be accompanied by many problems such as stiffness in the neck, headache, unilateral or bilateral shoulder pain, ocular and vestibular dysfunction.Pain caused by cervical disc herniation negatively affects the quality of life of the person.The decrease in mobility in the person with pain negatively affects physical performance, causing the person to experience inadequacies in daily life activities and decreased quality of life. In such patients, long-term imbalances between sympathetic and parasympathetic lead to various symptoms in the body. The advantages of technology applications in artificial intelligence-based rehabilitation are that it can be designed in accordance with the level and abilities of the individual, providing flexible configuration of parameters such as duration, intensity, difficulty and speed of the treatment for the therapist and patient, providing objective data with reliable and valid user detection equipment, providing real-time feedback, providing ease of activity training with real-life simulation, and reducing the possible burnout of the patient and therapist during the rehabilitation process. Conservative physiotherapy methods applied in physiotherapy have not been able to reduce the pain and participation in daily life. With artificial intelligence-assisted spinal rehabilitation, it is aimed to reduce pain and muscle spasm by determining the body calibration of individuals.

Eligibility criteria: Inclusion Criteria:

1. Being between 40-65 years old
2. Volunteering to participate in the study
3. No history of operated cervical disc herniation
4. Pain of 4 or more according to the numeric pain scale in the last 6 months

Exclusion Criteria:

1. Trauma or operation in the cervical region
2. Doing regular exercise
3. Regular use of psychiatric medication
4. Having known neurological, autoimmune diseases
5. Those who have a wound or infection in the area to be treated
6. Those with a pacemaker

Primary outcomes:
measure: Informed consent form (Appendix 1), sociodemographic assessment form (Appendix 2), Numeric Pain Scale for pain severity (Appendix 3), Notham Health Profile Questionnaire for general health assessment (Appendix 4), Beck Anxiety Index for anxiety (Appendix
timeFrame: Conventional physiotherapy group will last for 3 weeks with 15 sessions 5 days a week, treatment duration is 1 hour. Artificial intelligence supported spinal rehabilitation will be arranged for 6 sessions 3 days a week for half an hour. Evaluations will
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Iskenderun Gelişim Hastanesi
state: Iskenderun
Study officials:
References:
citation: Johnson JP, Masciopinto JE. Cervical-disk herniation. N Engl J Med. 1998 Sep 17;339(12):852; author reply 853. No abstract available.