Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation

NCT ID: NCT06632028

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-04

Study Completion Date

2024-11-04

Brief Summary

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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

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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

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Herniated Intervertebral Disc

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

artificial intelligence assisted spinal rehabilitation

Intervention Type OTHER

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 therapy

Intervention Type OTHER

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)

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.

Group Type OTHER

artificial intelligence assisted spinal rehabilitation

Intervention Type OTHER

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 therapy

Intervention Type OTHER

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)

Interventions

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artificial intelligence assisted spinal rehabilitation

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.

Intervention Type OTHER

conventional therapy

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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Okan University

OTHER

Sponsor Role lead

Responsible Party

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SENA NUR KESKİN

physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iskenderun Gelişim Hastanesi

Hatay, iskenderun, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Johnson JP, Masciopinto JE. Cervical-disk herniation. N Engl J Med. 1998 Sep 17;339(12):852; author reply 853. No abstract available.

Reference Type BACKGROUND
PMID: 9750087 (View on PubMed)

Related Links

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Other Identifiers

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OU-FTR-SNK-01

Identifier Type: -

Identifier Source: org_study_id

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