Artificial Intelligence Assisted Spine Rehabilitation in Cervical Disc Herniation

NCT06632028 | Completed

• 1 other identifier: OU-FTR-SNK-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Intervertebral Disc

Keywords

cervical disc herniation; artificial intelligence assisted spinal rehabilitation; traditional physiotherapy; pain; general health; Anxiety; disability; herniated intervertebral disc

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

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.

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.

Other: artificial intelligence assisted spinal rehabilitation; Other: conventional therapy

Interventions

artificial intelligence assisted spinal rehabilitation 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.

convention; stimawell

conventional therapy 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; stimawell

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Iskenderun Gelişim Hastanesi

Hatay, iskenderun, 31200, Turkey (Türkiye)

Location

Related Publications (1)

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

  PMID: 9750087 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 8, 2024
• Study Start: October 4, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)