Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation
February 9, 2025 updated by: SENA NUR KESKİN, Okan University
The EFFECT of ARTIFICIAL INTELLIGENCE ASSISTED SPINE REHABILITATION on GENERAL HEALTH, ANXIETY and DISABILITY in PATIENTS with CERVICAL DISC HERNIA
The aim of this study is to investigate the effect of artificial intelligence-assisted spinal rehabilitation in neck hernia compared to traditional methods.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iskenderun
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Hatay, Iskenderun, Turkey, 31200
- Iskenderun Gelişim Hastanesi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between 40-65 years old
- Volunteering to participate in the study
- No history of operated cervical disc herniation
- Pain of 4 or more according to the numeric pain scale in the last 6 months
Exclusion Criteria:
- Trauma or operation in the cervical region
- Doing regular exercise
- Regular use of psychiatric medication
- Having known neurological, autoimmune diseases
- Those who have a wound or infection in the area to be treated
- Those with a pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: stimawell
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.
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In artificial intelligence-based rehabilitation, it is more advantageous compared to other treatment methods in terms of the fact that technology applications can be designed according to the level and abilities of the individual and that the parameters such as duration, intensity, difficulty and speed of the treatment can be flexibly configured for the therapist and the patient.
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 among the most preferred methods in treatment.(6)
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Other: convention
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.
|
In artificial intelligence-based rehabilitation, it is more advantageous compared to other treatment methods in terms of the fact that technology applications can be designed according to the level and abilities of the individual and that the parameters such as duration, intensity, difficulty and speed of the treatment can be flexibly configured for the therapist and the patient.
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 among the most preferred methods in treatment.(6)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 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
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2024
Primary Completion (Actual)
November 4, 2024
Study Completion (Actual)
November 4, 2024
Study Registration Dates
First Submitted
October 7, 2024
First Submitted That Met QC Criteria
October 7, 2024
First Posted (Actual)
October 8, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 9, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OU-FTR-SNK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
When the study is finalised, researchers who want to use my data can send me an e-mail and use my data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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