Comparing cervical traction to placebo for treating neck pain from nerve root compression
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study
This study is testing if cervical traction can help relieve neck pain caused by nerve root compression better than a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Departemental Vendee Academic / other |
| Locations | 8 sites (La Roche-sur-Yon and 7 other locations) |
| Trial ID | NCT05952167 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cervical traction compared to a placebo treatment in patients suffering from cervical radiculopathy, a condition caused by nerve root compression in the neck. The study involves an intensive cervical traction protocol administered by physiotherapists, aiming to alleviate pain and dysfunction associated with the condition. Participants will be assessed based on specific clinical signs of cervical radiculopathy and must meet certain eligibility criteria to ensure accurate results. The trial seeks to provide evidence on whether cervical traction can be a viable conservative treatment option before considering more invasive surgical interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with diagnosed cervical radiculopathy and specific clinical signs indicating the condition.
Not a fit: Patients with severe cervical conditions such as myelopathy or cervical cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for patients suffering from cervical radiculopathy, potentially reducing the need for surgery.
How similar studies have performed: Previous studies on cervical traction have shown mixed results, indicating that this approach is still under investigation and not yet fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 * Neck Disability Index ≥ 15/50 * Presence of at least three of the four signs clinically validating the presence of cervical radiculopathy (Wainner et al. 2003) * a) upper limb nerve tension test A (ULNT1a): positive, * b) amplitude of cervical rotation on the side concerned: \< 60°, * c) positive cervical distraction test: relief * d) positive Spurling test: reproduction of symptoms. * Cervical radiculopathy diagnosed 3 to 24 months previously * Absence of cervical traction in the 5 years prior to inclusion * MRI or CT scan performed prior to hospitalisation in relation to current pathology * Patient able to understand the protocol and having given oral informed consent to take part in the research. * Patient affiliated to the social security system or entitled beneficiary. Exclusion Criteria: * Patients with vertebral artery pathology at the time of inclusion * Patients with myelopathy, cervical cancer, cervical fracture, cervical dislocation, cervical spondylolisthesis, spinal infection, symptomatic cervical pain without radiculopathy and/or cervical surgery in the 2 years prior to inclusion. * Patient participating in another clinical research protocol with an impact on the objectives of the research. * Patient who is pregnant, breastfeeding or able to procreate without effective contraception\*. * Patient under guardianship, curatorship or deprived of liberty * Patient under activated future protection mandate * Patient under family habilitation * Patient under court protection.
Where this trial is running
La Roche-sur-Yon and 7 other locations
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- CH La Rochelle — La Rochelle, France (Recruiting)
- CH Emile Roux — Le Puy-en-Velay, France (Terminated)
- CHU Limoges — Limoges, France (Recruiting)
- CHU Nantes — Nantes, France (Recruiting)
- APHP La Pitié Salpêtrière — Paris, France (Recruiting)
- Chu Reims — Reims, France (Recruiting)
- CHU Rouen — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Thomas RULLEAU — Nantes University Hospital
- Study coordinator: Chloé MOREAU
- Email: chloe.moreau@ght85.fr
- Phone: 0251446327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.