Cervical StenosisRC REPRONCT07886112
Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation.
A study testing Questionnaires and Physical tests in people with Cervical Stenosis and Cervical Spine, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Cervical stenosis is characterized by a narrowing of the spinal canal that exerts pressure on adjacent sensitive areas, potentially causing significant neck pain and cervicobrachial neuralgia accompanied by functional limitations-conditions that are particularly disabling for athletes. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Stenosis, Cervical Spine
- What is being tested?
- Questionnaires and Physical tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2022to 20 Dec 2026
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient group
- Patients meeting all the following criteria will be included:
- Male or female aged 18 to 40 years
- Injury requiring surgery sustained during a sports activity
- Participation in sports activity at least once a week
- Cervical spine arthrodesis, cervical disc replacement, and/or foraminotomy
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- Surgery performed by surgeons at the Centre Orthopédique Santy (Lyon)
- Inclusion based on the surgeon's decision during the 45-day post-operative visit
- Control group
- Participants meeting all the following criteria will be included:
- Male or female aged 18 to 40 years
- Participation in sports activity at least once a week
- No history of cervical pathology
- No history of surgery involving the shoulder girdle
- No neck pain in the month prior to the test
- In both groups o Patient having signed an informed consent form Subject affiliated with or a beneficiary of a social security scheme
Who cannot join
- Patient group
- Patients meeting any of the following criteria will be excluded:
- o Medical contraindication
- Control group
- Participants meeting any of the following criteria will be excluded:
- Reported history of spinal or upper-limb injury within the last 12 months
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- Reported history of upper-limb surgery
- In all cases, the following will be excluded:
- Protected individuals: adults under guardianship, curatorship, or other legal protection; individuals deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding, or recently delivered women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
Marc Szadkowski, Dr, 0437530048 ext. 0033, marcszad@yahoo.fr
About this study
Official title: Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation : Comparison Between a Group of Patients and a Group of Healthy Controls
Cervical stenosis is characterized by a narrowing of the spinal canal that exerts pressure on adjacent sensitive areas, potentially causing significant neck pain and cervicobrachial neuralgia accompanied by functional limitations-conditions that are particularly disabling for athletes. Among the athletic population, anterior cervical discectomy with fusion is the gold-standard surgical treatment. Currently, there is no consensus regarding the timing for a safe return to sports following surgical treatment for cervical stenosis. While various clinical tests are used to assess mobility or pain, no single test specifically evaluates the level of functional recovery.
- Conditions
- Cervical Stenosis, Cervical Spine
- Being tested
- Questionnaires, Physical tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Questionnaire Neck Disability Index (NDI) Questionnaire Neck Return to Sport after Injury (N-RSI)
Physical testsOther
- Flexion and Extension Range of Motion
- Clockwise and Counter-clockwise Rotations
- Maximum isometric forces
- Cervical spine flexor strength endurance
- One-arm medicine ball throw
- Closed Kinetic Chain Upper Extremity Stability Test modified
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Cervical spine arthrodesis or cervical disc replacement and/or foraminotomy. All patients performed functionnal tests and one in two participants will be randomly selected to complete a second administration 45 days later-that is, at the 90-day mark. Receives: Other: Questionnaires; Other: Physical tests |
| Healthy volunteers | Active comparator | They performed functionnal tests followed by a second session a week later. Receives: Other: Questionnaires; Other: Physical tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Neck Return to Sport after Injury score
The questionnaire consists of three subscales assessing emotions, confidence in performance ability, and perceived risk of re-injury, comprising a total of 12 items rated from 0 to 10. The outcome measure (N-RSI) is derived by summing the scores of the 12 items, scaling the result to a maximum of 100, and expressing it as a percentage.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start19 Jul 2022
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical StenosisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886112
- Sponsor's protocol ID
- 2021-A02771-40
- Acronym
- RC REPRO
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation : Comparison Between a Group of Patients and a Group of Healthy Controls
- ClinicalTrials.gov ID
- NCT07886112
- Acronym / sponsor ID
- RC REPRO / 2021-A02771-40
- Conditions
- Cervical Stenosis, Cervical Spine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 21 Oct 2026 (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.
Cervical stenosis is characterized by a narrowing of the spinal canal that exerts pressure on adjacent sensitive areas, potentially causing significant neck pain and cervicobrachial neuralgia accompanied by functional limitations-conditions that are particularly disabling for athletes. Among the athletic population, anterior cervical discectomy with fusion is the gold-standard surgical treatment. Currently, there is no consensus regarding the timing for a safe return to sports following surgical treatment for cervical stenosis. While various clinical tests are used to assess mobility or pain, no single test specifically evaluates the level of functional recovery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Questionnaires, Other: Physical testsCervical spine arthrodesis or cervical disc replacement and/or foraminotomy. All patients performed functionnal tests and one in two participants will be randomly selected to complete a second administration 45 days later-that is, at the 90-day mark. |
| Healthy volunteers | Active comparator | Other: Questionnaires, Other: Physical testsThey performed functionnal tests followed by a second session a week later. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Patient group
- Male or female aged 18 to 40 years
- Injury requiring surgery sustained during a sports activity
- Participation in sports activity at least once a week
- Cervical spine arthrodesis, cervical disc replacement, and/or foraminotomy
Key exclusion criteria (10 listed)
- Patient group
- o Medical contraindication
- Control group
- Reported history of spinal or upper-limb injury within the last 12 months
- Reported history of upper-limb surgery
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 |
|---|---|---|
| QuestionnairesQuestionnaire Neck Disability Index (NDI) Questionnaire Neck Return to Sport after Injury (N-RSI) | Other | Healthy volunteers, Patients |
| Physical tests* Flexion and Extension Range of Motion * Clockwise and Counter-clockwise Rotations * Maximum isometric forces * Cervical spine flexor strength endurance * One-arm medicine ball throw * Closed Kinetic Chain Upper Extremity Stability Test modified | Other | Healthy volunteers, Patients |
Primary outcome
Questionnaire Neck Return to Sport after Injury score
Time frame: 45 days
The questionnaire consists of three subscales assessing emotions, confidence in performance ability, and perceived risk of re-injury, comprising a total of 12 items rated from 0 to 10. The outcome measure (N-RSI) is derived by summing the scores of the 12 items, scaling the result to a maximum of 100, and expressing it as a percentage.
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 21 Oct 2026.
Related trials for Cervical Stenosis
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Cervical Disc Herniation, Cervical Foraminal Stenosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
Active, not recruitingPhase 2
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma
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Hard Cervical Collar Use Following Posterior Cervical Fusion
Spinal Stenosis Cervical, Radiculopathy, Cervical Region
RecruitingObservational study
PMCF Study Fortilink-SC
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
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.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and Physical tests in people with Cervical Stenosis and Cervical Spine, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 16 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 France. 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?
Contact Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire Neck Return to Sport after Injury score (time frame: 45 days). 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 21 Oct 2026.