Cervical Disc HerniationNCT07282522
Sensory and Functional Impairments in Cervical Disc Herniation
An observational study of Cervical Disc Herniation, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the levels of somatosensory perception, pain threshold and kinesiophobia in individuals with SDH, to examine their relationship with upper extremity functional skills and to compare them with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- Somatosensory Perception Tests, The Visual Analog Scale and Pain Threshold and Tolerance Assessment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2025to 12 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- Women only
- Adult, Older adult
Study population: Cervical disc herniation and healthy individuals
Inclusion criteria for volunteers in the study: Neck pain lasting at least 3 months, Being between the ages of 18-65 with a diagnosis of cervical disc herniation, Being able to cooperate with the applied parameters, Having good cognitive function, Being literate, Agreeing to participate in the study.
For the control group, having no complaints of neck pain and not having any neck-related diagnosis.
Exclusion criteria for volunteers in the study: Neck pain intensity during activity according to the Visual Analog Scale (VAS) below 3, Individuals who have undergone any surgery related to neck problems, Individuals who have undergone surgery related to upper extremity problems, Individuals with cervical radiculopathy, Having a systemic malignant disease anywhere in the body, Having any disease related to connective tissue or inflammatory rheumatic diseases, Having a psychiatric diagnosis and receiving treatment, Being illiterate, Not having sufficient cognitive function, Having received any neck-related physical therapy in the last 6 months for the CBA group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dilan Demirtas Karaoba
Iğdır, Iğdir
DILAN DEMIRTAS KARAOBA, asst. prof, 05541127796, dilandemirtas92@gmail.com
Büşra Candiri, asst. prof
About this study
Official title: Investigation of Somatosensory Perception, Pain, Kinesiophobia, and Upper Extremity Functional Skills in Cervical Disc Herniation: A Case-Control Study
The aim of the study was to evaluate the levels of somatosensory perception, pain threshold and kinesiophobia in individuals with SDH, to examine their relationship with upper extremity functional skills and to compare them with healthy individuals.
Read the detailed description
Cervical disc herniation (SDH) occurs when nerve roots and/or spinal cord are compressed due to degeneration or displacement of the cervical intervertebral disc and can present with pain, sensory loss, muscle weakness, and functional limitations. Because the C5-T1 nerve roots provide motor and sensory innervation from the shoulder to the hand, SDH can cause not only pain but also impairments in somatosensory perception, tactile sensations, and proprioceptive awareness. Nerve root compression disrupts the integrity of sensory functions such as touch, vibration, and two-point discrimination, negatively impacting upper extremity abilities. Furthermore, pain and central sensitization processes lower the pain threshold, further limiting motor performance and activities of daily living. Therefore, the combined evaluation of somatosensory perception, pain, and functional abilities in individuals with SDH is crucial for a holistic understanding of the clinical picture.
- Conditions
- Cervical Disc Herniation
- Being tested
- Somatosensory Perception Tests, The Visual Analog Scale, Pain Threshold and Tolerance Assessment, Upper extremity functionality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory Perception TestsOther
Tactile Localization Test The tactile localization test assesses touch perception. Finger Recognition Test The participant is asked to point to their finger, which has been touched with a pen, while their eyes are closed.
Double-Touch Stimulus Perception Test This test is based on the identification of two separate stimuli presented simultaneously.
The Visual Analog ScaleOther
The Visual Analog Scale evaluates the intensity of pain felt by patients in different activities and time periods (rest, activity and night) in centimeters (cm).
Pain Threshold and Tolerance AssessmentOther
Participants' pain threshold and tolerance to pressure are assessed using a digital algometer (JTech Medical Industries, ZEVEX Company).
Upper extremity functionalityOther
Upper extremity functionality will be assessed using the DASH and Purdue Pegboard Manual Dexterity Test.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with SDH | Individuals with SDH are patients diagnosed with cervical disc herniation by a physical therapist. Receives: Other: Somatosensory Perception Tests; Other: The Visual Analog Scale; Other: Pain Threshold and Tolerance Assessment; Other: Upper extremity functionality | |
| healthy participants. | Individuals with similar demographic characteristics who did not have any neck pain during the initial interview were considered healthy participants. Receives: Other: Somatosensory Perception Tests; Other: The Visual Analog Scale; Other: Pain Threshold and Tolerance Assessment; Other: Upper extremity functionality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity functionality
Upper extremity functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire and Purdue Pegboard Manual Dexterity Test.The total score ranges from 0 to 100, with higher scores indicating a higher level of upper extremity disability.
Measured: 24-48 hours
Pain Threshold and Tolerance Assessment
Participants' pain threshold and tolerance to pressure are assessed using a digital algometer (JTech Medical Industries, ZEVEX Company).
Measured: 24-48 hours
Pain Assessment evaluates
Pain Assessment evaluates the intensity of pain felt by patients in centimeters (cm) during different activities and time periods (rest, activity and night).
Measured: 24-48 hours
Somatosensory Perception Tests
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start24 Oct 2025
- Primary completion3 Dec 2025
- Study completion12 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilan Demirtaş Karaoba, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282522
- Sponsor's protocol ID
- 2025/8426
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Somatosensory Perception, Pain, Kinesiophobia, and Upper Extremity Functional Skills in Cervical Disc Herniation: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07282522
- Acronym / sponsor ID
- 2025/8426
- Conditions
- Cervical Disc Herniation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 12 Mar 2026 (estimated)
- First posted
- 15 Dec 2025 (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 the study was to evaluate the levels of somatosensory perception, pain threshold and kinesiophobia in individuals with SDH, to examine their relationship with upper extremity functional skills and to compare them with healthy individuals.
Detailed description
Cervical disc herniation (SDH) occurs when nerve roots and/or spinal cord are compressed due to degeneration or displacement of the cervical intervertebral disc and can present with pain, sensory loss, muscle weakness, and functional limitations. Because the C5-T1 nerve roots provide motor and sensory innervation from the shoulder to the hand, SDH can cause not only pain but also impairments in somatosensory perception, tactile sensations, and proprioceptive awareness. Nerve root compression disrupts the integrity of sensory functions such as touch, vibration, and two-point discrimination, negatively impacting upper extremity abilities. Furthermore, pain and central sensitization processes lower the pain threshold, further limiting motor performance and activities of daily living. Therefore, the combined evaluation of somatosensory perception, pain, and functional abilities in individuals with SDH is crucial for a holistic understanding of the clinical picture.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with SDH | – | Other: Somatosensory Perception Tests, Other: The Visual Analog Scale, Other: Pain Threshold and Tolerance Assessment, Other: Upper extremity functionalityIndividuals with SDH are patients diagnosed with cervical disc herniation by a physical therapist. |
| healthy participants. | – | Other: Somatosensory Perception Tests, Other: The Visual Analog Scale, Other: Pain Threshold and Tolerance Assessment, Other: Upper extremity functionalityIndividuals with similar demographic characteristics who did not have any neck pain during the initial interview were considered healthy participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Cervical disc herniation and healthy individuals
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 |
|---|---|---|
| Somatosensory Perception TestsTactile Localization Test The tactile localization test assesses touch perception. Finger Recognition Test The participant is asked to point to their finger, which has been touched with a pen, while their eyes are closed. Double-Touch Stimulus Perception Test This test is based on the identification of two separate stimuli presented simultaneously. | Other | Individuals with SDH, healthy participants. |
| The Visual Analog ScaleThe Visual Analog Scale evaluates the intensity of pain felt by patients in different activities and time periods (rest, activity and night) in centimeters (cm). | Other | Individuals with SDH, healthy participants. |
| Pain Threshold and Tolerance AssessmentParticipants' pain threshold and tolerance to pressure are assessed using a digital algometer (JTech Medical Industries, ZEVEX Company). | Other | Individuals with SDH, healthy participants. |
| Upper extremity functionalityUpper extremity functionality will be assessed using the DASH and Purdue Pegboard Manual Dexterity Test. | Other | Individuals with SDH, healthy participants. |
Primary outcome
Upper extremity functionality
Time frame: 24-48 hours
Upper extremity functionality will be assessed using the Disabilities of the Arm, Shoulder, and Hand questionnaire and Purdue Pegboard Manual Dexterity Test.The total score ranges from 0 to 100, with higher scores indicating a higher level of upper extremity disability.
Pain Threshold and Tolerance Assessment
Time frame: 24-48 hours
Participants' pain threshold and tolerance to pressure are assessed using a digital algometer (JTech Medical Industries, ZEVEX Company).
Pain Assessment evaluates
Time frame: 24-48 hours
Pain Assessment evaluates the intensity of pain felt by patients in centimeters (cm) during different activities and time periods (rest, activity and night).
Somatosensory Perception Tests
Time frame: 24-48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Disc Herniation, run by Inonu 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?
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: looking for participants now, as of the sponsor's last update on 22 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity functionality (time frame: 24-48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.