Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation

Not Applicable

Completed

• Conditions: Herniated Intervertebral Disc
• Interventions: Other: artificial intelligence assisted spinal rehabilitation; Other: conventional therapy

• Registration Number: NCT06632028
• Lead Sponsor: Okan University

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.

Study Timeline

• Study Start: 2024-10-04
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-08
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stimawell	artificial intelligence assisted spinal rehabilitation	In the treatment programme to be applied to the spinal rehabilitation group supported by artificial intelligence, the patient's treatment card is first created. Artificial intelligence assisted spinal rehabilitation group will be applied 3 times a week, a total of 6 sessions and 30 minutes of treatment. The person is first prepared by lying on his back on the stimulation mat. There are 12 channels and 24 electrodes in artificial intelligence assisted spinal rehabilitation. The stimulation wave travels in all 12 L-sized channels of the stimulation mat. The two sub-channels in the M dimension are not active, the wave travels over only 10 channels. In size S only 8 channels are used, therefore 4 sub-channels of the stimulation mat are not active Artificial intelligence-assisted spinal rehabilitation overcomes skin resistance more easily with mid-frequency currents in the 2000 - 6000 Hz range compared to currents in lower frequency ranges.
stimawell	conventional therapy	In the treatment programme to be applied to the spinal rehabilitation group supported by artificial intelligence, the patient's treatment card is first created. Artificial intelligence assisted spinal rehabilitation group will be applied 3 times a week, a total of 6 sessions and 30 minutes of treatment. The person is first prepared by lying on his back on the stimulation mat. There are 12 channels and 24 electrodes in artificial intelligence assisted spinal rehabilitation. The stimulation wave travels in all 12 L-sized channels of the stimulation mat. The two sub-channels in the M dimension are not active, the wave travels over only 10 channels. In size S only 8 channels are used, therefore 4 sub-channels of the stimulation mat are not active Artificial intelligence-assisted spinal rehabilitation overcomes skin resistance more easily with mid-frequency currents in the 2000 - 6000 Hz range compared to currents in lower frequency ranges.
convention	artificial intelligence assisted spinal rehabilitation	In the traditional treatment group, a total of 15 sessions, 5 times a week, and in each session, 20 minutes of TENS application with the conventional method by placing electrodes on the painful points of the person, 20 minutes of hotpack application and 4 minutes each on the right and left sides of the neck area with intermittent ultrasound 1.5 MHz wave will be applied for a total of 8 minutes. Cervical isometric exercises will be given and 2 sets of 10 repetitions will be performed with 5 sec stretching.
convention	conventional therapy	In the traditional treatment group, a total of 15 sessions, 5 times a week, and in each session, 20 minutes of TENS application with the conventional method by placing electrodes on the painful points of the person, 20 minutes of hotpack application and 4 minutes each on the right and left sides of the neck area with intermittent ultrasound 1.5 MHz wave will be applied for a total of 8 minutes. Cervical isometric exercises will be given and 2 sets of 10 repetitions will be performed with 5 sec stretching.

Primary Outcome Measures

Name	Time	Method
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	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	In the 11-question form prepared in line with the literature, information such as personal information, contact information, medications used and whether the patient has undergone any operation are questioned. Numeric Pain Scale (NAS), which is one of the methods commonly used to determine the severity of pain, is a valid and reliable scale used to measure all pain intensities. The Beck Anxiety Scale consists of 21 questions and is used to indicate the anxiety level of individuals aged 12 years and over. Copenhagen Neck Functionality Disability Scale is a 15-item scale that measures the severity of pain and the effect of pain severity on disability in daily activities, social interaction and recreational activities and measures the person's perception of the effect of neck pain on the future. Nottingham Health Profile NSP is a general quality of life questionnaire that measures the person's perceived health problems and the extent to which these problems affect normal daily activitie

Trial Locations

Locations (1)

Iskenderun Gelişim Hastanesi; 🇹🇷 Hatay, Iskenderun, Turkey