The effect of mechanical traction on cervical radiculopathy: protocol for the TracCerv2 single-blind, randomised controlled trial.
Grégoire Cormier, Chloé Moreau, Emilie Scalisi...
https://pubmed.ncbi.nlm.nih.gov/39953437Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05952167
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy Randomised Controlled Trial in a Single-blind Study
Led by Centre Hospitalier Departemental Vendee · Updated on 2026-04-15
206
Participants Needed
8
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of an intensive cervical traction protocol compared to a placebo traction in patients with cervical radiculopathy, a condition caused by nerve root compression in the spine that leads to pain and dysfunction. This condition affects about 3.5 per 1000 people and can result in time off work and costly treatments. While conservative treatments like physiotherapy and medication are common first approaches, the effectiveness of cervical traction remains debated due to varying study results and protocols. This trial aims to clarify traction's specific effects using a robust experimental design as part of a larger research effort to improve treatment recommendations. Participants will receive either an intensive mechanical cervical traction protocol or a placebo version, both applied twice daily over five consecutive weekdays with at least eight pull-ups during this period. The study is randomized and single-blind, meaning participants will be assigned to one of the two groups without knowing which treatment they receive. This design allows researchers to compare the true effect of the traction against a placebo treatment under controlled conditions. During the study, participants' progress will be monitored, focusing on the Neck Disability Index (NDI) score to measure improvement in symptoms three months after finishing the traction protocol. Patients must meet specific clinical signs of cervical radiculopathy and have undergone recent imaging such as MRI or CT scans. Safety and adherence will be tracked, with follow-up assessments evaluating changes in disability and symptom relief. The total duration includes the treatment phase over five days and outcome measurement at three months post-treatment.
CONDITIONS
Brief Title
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Neck Disability Index score of 15 or higher out of 50
- Presence of at least three of the following clinical signs: positive upper limb nerve tension test A, cervical rotation less than 60 degrees on the affected side, positive cervical distraction test with relief, positive Spurling test reproducing symptoms
- Cervical radiculopathy diagnosed between 3 and 24 months before participation
- No cervical traction treatment in the 5 years before joining the study
- MRI or CT scan completed before hospitalisation related to the current condition
- Ability to understand the study protocol and provide oral informed consent
- Affiliation with the social security system or entitled beneficiary
You will not qualify if you...
- Vertebral artery pathology at the time of inclusion
- Myelopathy, cervical cancer, cervical fracture, cervical dislocation, cervical spondylolisthesis, spinal infection, symptomatic cervical pain without radiculopathy, or cervical surgery within 2 years prior to inclusion
- Participation in another clinical research protocol that affects the study objectives
- Pregnancy, breastfeeding, or ability to procreate without effective contraception
- Under guardianship, curatorship, court protection, or deprived of liberty
- Under activated future protection mandate or family habilitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 week
Participants receive intensive cervical traction or placebo traction twice a day over 5 weekdays, with a minimum of 8 sessions over 5 consecutive days.
10 visits (in-person) over 5 weekdays
Follow-up
Duration - 3 months
Participants are monitored for outcomes and recovery up to 3 months after completing the cervical traction protocol.
1 visit at 3 months post-treatment
Trial Site Locations
Total: 8 locations
1
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
2
CH La Rochelle
La Rochelle, France
Actively Recruiting
3
CH Emile Roux
Le Puy-en-Velay, France
Terminated
4
CHU Limoges
Limoges, France
Actively Recruiting
5
CHU Nantes
Nantes, France
Actively Recruiting
6
APHP La Pitié Salpêtrière
Paris, France
Actively Recruiting
7
Chu Reims
Reims, France
Actively Recruiting
8
CHU Rouen
Rouen, France
Actively Recruiting
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Research Team
C
Chloé MOREAU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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