Cervical RadiculopathyNCT07152522
Association Between Neck Disability Index Categories and Multidirectional Range of Motion in Patient With Cervical Radiculopathy
An observational study of Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to investigate the association between NDI categories (None, Mild, Moderate, Severe) and ROM in six directions: flexion, extension, right and left side bending, and right and left rotation. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- cross sectional observational
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 25 Jul 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will be conducted in the out-patient clinic Faculty of physical therapy, Cairo University. The expected duration to recruit patients and collect data is 6 months .
Who may be able to join
- Both male \& female
- Aged 25-60
- BMI 18.5: 25
- With cervical radiculopathy that persist for more than 3 months
Who cannot join
- Prior surgery to the cervicothoracic spine
- Bilateral symptoms
- Signs of upper motor neuron impairments
- Cervical spine injection in the previous 4 weeks
- Current use of steroidal anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Neck Disability Index Categories and Multidirectional Range of Motion in Patient With Cervical Radiculopathy: Insights From a Cross-Sectional Study
This study aims to investigate the association between NDI categories (None, Mild, Moderate, Severe) and ROM in six directions: flexion, extension, right and left side bending, and right and left rotation. Additionally, it seeks to identify which movements are most affected by neck disability and explore their predictive value for overall ROM changes.
Read the detailed description
Neck pain is a prevalent musculoskeletal condition that affects a significant portion of the population, with substantial implications for daily functioning and quality of life. The Neck Disability Index (NDI) is a widely used tool to assess the severity of neck pain and its impact on functional activities. Understanding how neck disability correlates with physical impairments, such as reduced range of motion (ROM), is crucial for effective diagnosis and management of this condition.
Despite the established relationship between neck pain and functional limitations, there is limited research quantifying the specific impact of varying levels of neck disability on multidirectional ROM. Furthermore, key directions of movement most affected by neck pain remain underexplored, limiting the ability of clinicians to target interventions effectively.
Scope and Limitations This cross-sectional study focuses on ROM measurements and their relationship with NDI categories. While providing valuable insights, it does not assess changes over time or include other factors such as muscle strength or pain intensity. Addressing these aspects in future research can provide a more comprehensive understanding of neck pain and its implications.
This cross-sectional study included 80 patients diagnosed with neck pain. Participants were categorized into four groups based on their Neck Disability Index (NDI) scores: None, Mild, Moderate, and Severe. Inclusion criteria required participants to have chronic neck pain, while individuals with systemic diseases or comorbid conditions affecting mobility were exclude.
Neck range of motion (ROM) was measured in six directions: flexion, extension, right and left side bending, and right and left rotation. ROM was assessed using a standardized goniometer, and all measurements were performed by the same trained examiner to ensure consistency. NDI scores were obtained through a validated self-reported questionnaire.
- Conditions
- Cervical Radiculopathy
- Being tested
- cross sectional observational
- Keywords
- cervical range of motion, neck disability index, cervical radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross sectional observationalOther
the therapist measured ROM in six directions: flexion, extension, right and left side bending, and right and left rotation to investigate the association between NDI and ROM of cervical spine
| Study group | Role | What they receive |
|---|---|---|
| cervical radiculopathy with not affected NDI | Not described Receives: Other: cross sectional observational | |
| cervical radiculopathy with mild NDI | Not described Receives: Other: cross sectional observational | |
| cervical radiculopathy with moderate NDI | Not described Receives: Other: cross sectional observational | |
| cervical radiculopathy with severe NDI | Not described Receives: Other: cross sectional observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
the association between NDI categories (None, Mild, Moderate, Severe) and ROM in six directions: flexion, extension, right and left side bending, and right and left rotation.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Mar 2025
- Primary completion1 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Amir Nassif Naguib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152522
- Sponsor's protocol ID
- FPTBSUREC/0505/2325
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Neck Disability Index Categories and Multidirectional Range of Motion in Patient With Cervical Radiculopathy: Insights From a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07152522
- Acronym / sponsor ID
- FPTBSUREC/0505/2325
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical range of motion, neck disability index, cervical radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 3 Sep 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.
This study aims to investigate the association between NDI categories (None, Mild, Moderate, Severe) and ROM in six directions: flexion, extension, right and left side bending, and right and left rotation. Additionally, it seeks to identify which movements are most affected by neck disability and explore their predictive value for overall ROM changes.
Detailed description
Neck pain is a prevalent musculoskeletal condition that affects a significant portion of the population, with substantial implications for daily functioning and quality of life. The Neck Disability Index (NDI) is a widely used tool to assess the severity of neck pain and its impact on functional activities. Understanding how neck disability correlates with physical impairments, such as reduced range of motion (ROM), is crucial for effective diagnosis and management of this condition.
Despite the established relationship between neck pain and functional limitations, there is limited research quantifying the specific impact of varying levels of neck disability on multidirectional ROM. Furthermore, key directions of movement most affected by neck pain remain underexplored, limiting the ability of clinicians to target interventions effectively.
Scope and Limitations This cross-sectional study focuses on ROM measurements and their relationship with NDI categories. While providing valuable insights, it does not assess changes over time or include other factors such as muscle strength or pain intensity. Addressing these aspects in future research can provide a more comprehensive understanding of neck pain and its implications.
This cross-sectional study included 80 patients diagnosed with neck pain. Participants were categorized into four groups based on their Neck Disability Index (NDI) scores: None, Mild, Moderate, and Severe. Inclusion criteria required participants to have chronic neck pain, while individuals with systemic diseases or comorbid conditions affecting mobility were exclude.
Neck range of motion (ROM) was measured in six directions: flexion, extension, right and left side bending, and right and left rotation. ROM was assessed using a standardized goniometer, and all measurements were performed by the same trained examiner to ensure consistency. NDI scores were obtained through a validated self-reported questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cervical radiculopathy with not affected NDI | – | Other: cross sectional observational |
| cervical radiculopathy with mild NDI | – | Other: cross sectional observational |
| cervical radiculopathy with moderate NDI | – | Other: cross sectional observational |
| cervical radiculopathy with severe NDI | – | Other: cross sectional observational |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will be conducted in the out-patient clinic Faculty of physical therapy, Cairo University. The expected duration to recruit patients and collect data is 6 months .
Key inclusion criteria (4 listed)
- Both male \& female
- Aged 25-60
- BMI 18.5: 25
- With cervical radiculopathy that persist for more than 3 months
Key exclusion criteria (5 listed)
- Prior surgery to the cervicothoracic spine
- Bilateral symptoms
- Signs of upper motor neuron impairments
- Cervical spine injection in the previous 4 weeks
- Current use of steroidal anti-inflammatory drugs
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 |
|---|---|---|
| cross sectional observationalthe therapist measured ROM in six directions: flexion, extension, right and left side bending, and right and left rotation to investigate the association between NDI and ROM of cervical spine | Other | cervical radiculopathy with mild NDI, cervical radiculopathy with moderate NDI, cervical radiculopathy with not affected NDI, cervical radiculopathy with severe NDI |
Primary outcome
the association between NDI categories (None, Mild, Moderate, Severe) and ROM in six directions: flexion, extension, right and left side bending, and right and left rotation.
Time frame: 5 months
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 3 Sep 2025.
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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. 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?
An observational study of Cervical Radiculopathy, run by Cairo University at 1 site in Egypt.
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 5 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 3 Sep 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 Egypt. 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?
the association between NDI categories (None, Mild, Moderate, Severe) and ROM in six directions: flexion, extension, right and left side bending, and right and left rotation. (time frame: 5 months). 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 3 Sep 2025.