Herniated Intervertebral DiscNCT06632028
Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation
A study testing artificial intelligence assisted spinal rehabilitation and conventional therapy in people with Herniated Intervertebral Disc, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of artificial intelligence-assisted spinal rehabilitation in neck hernia compared to traditional methods. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Herniated Intervertebral Disc
- What is being tested?
- artificial intelligence assisted spinal rehabilitation and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2024to 4 Nov 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Iskenderun Gelişim Hastanesi
Hatay, iskenderun, 31200
About this study
Official title: 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.
Read the 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.
- Conditions
- Herniated Intervertebral Disc
- Being tested
- artificial intelligence assisted spinal rehabilitation, conventional therapy
- Keywords
- cervical disc herniation, artificial intelligence assisted spinal rehabilitation, traditional physiotherapy, pain, general health, Anxiety, disability, herniated intervertebral disc
- Medical subject headings
- Intervertebral Disc Displacement, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligence assisted spinal rehabilitationOther
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.
conventional therapyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| stimawell | Active comparator | 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. Receives: Other: artificial intelligence assisted spinal rehabilitation; Other: conventional therapy |
| convention | Other | 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. Receives: Other: artificial intelligence assisted spinal rehabilitation; Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Oct 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 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 Herniated Intervertebral DiscStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SENA NUR KESKİN, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632028
- Sponsor's protocol ID
- OU-FTR-SNK-01
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the study is finalised, researchers who want to use my data can send me an e-mail and use my data.
Publications
Johnson JP, Masciopinto JE. Cervical-disk herniation. N Engl J Med. 1998 Sep 17;339(12):852; author reply 853. No abstract available.
PubMed 9750087
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ARTIFICIAL INTELLIGENCE ASSISTED SPINE REHABILITATION ON GENERAL HEALTH, ANXIETY AND DISABILITY IN PATIENTS WITH CERVICAL DISC HERNIA
- ClinicalTrials.gov ID
- NCT06632028
- Acronym / sponsor ID
- OU-FTR-SNK-01
- Conditions
- Herniated Intervertebral Disc
- Keywords
- cervical disc herniation, artificial intelligence assisted spinal rehabilitation, traditional physiotherapy, pain, general health, Anxiety, disability, herniated intervertebral disc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 8 Oct 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| stimawell | Active comparator | Other: artificial intelligence assisted spinal rehabilitation, Other: conventional therapyIn 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 | Other | Other: artificial intelligence assisted spinal rehabilitation, Other: conventional therapyIn 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| artificial intelligence assisted spinal rehabilitationIn 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. | Other | convention, stimawell |
| conventional therapyIn 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) | Other | convention, stimawell |
Primary outcome
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
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
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 11 Feb 2025.
- Background: PubMed 9750087Johnson JP, Masciopinto JE. Cervical-disk herniation. N Engl J Med. 1998 Sep 17;339(12):852; author reply 853. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. When the study is finalised, researchers who want to use my data can send me an e-mail and use my data.
Related trials for Herniated Intervertebral Disc
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial intelligence assisted spinal rehabilitation and conventional therapy in people with Herniated Intervertebral Disc, run by Okan 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 4 inclusion and 6 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 11 Feb 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?
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). 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 NCT06632028, 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 11 Feb 2025.