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.

NCT07886112 | Recruiting

• 1 other identifier: 2021-A02771-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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 Spine; Cervical Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  45 days

Study Arms (2)

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.

Other: Questionnaires; Other: Physical tests

Healthy volunteers

ACTIVE COMPARATOR

They performed functionnal tests followed by a second session a week later.

Other: Questionnaires; Other: Physical tests

Interventions

Physical tests OTHER

* 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

Healthy volunteers; Patients

Questionnaires OTHER

Questionnaire Neck Disability Index (NDI) Questionnaire Neck Return to Sport after Injury (N-RSI)

Healthy volunteers; Patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Surgery performed by surgeons at the Centre Orthopédique Santy (Lyon)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-François Oudet

CONTACT

0033683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: July 19, 2022
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

FR (1)