Actively Recruiting
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy
Led by Centre Hospitalier Departemental Vendee · Updated on 2026-04-15
206
Participants Needed
8
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cervical radiculopathy is a common disease related to compression of the nerve roots of the spine (prevalence: 3.5/1000). Dysfunction and pain are the main repercussions and can lead to time off work and high costs in terms of treatment. Second-line surgical treatments appear to be less effective and present risks of side effects. In the first instance, treatments are conservative and include medication but above all physiotherapy with manual therapy, muscle exercises and cervical traction. These cervical tractions performed by a physiotherapist require little equipment and are inexpensive compared with the surgical alternative. They involve stretching the cervical spine and soft tissues to open the intervertebral foramen and mobilise the facet joints. Several authors have written summaries of their interest. Thoomes reports two studies and describes an absence of effect. In a meta-analysis, Romeo et al. added three more recent studies to the previous review and concluded that traction is effective, highlighting an "effect-dose" relationship. These recent results therefore seem to reverse the recommendations made barely two years later. Nevertheless, almost all the studies compared "manual therapy + exercises" with "manual therapy + exercises + cervical traction". Only Young et al. tested "manual therapy + exercises + cervical traction at an effective weight" compared to "manual therapy + exercises + cervical traction placebo at an ineffective weight". The study did not reveal any difference between the groups. However, several limitations appear in this study when comparing the protocol to studies that have shown efficacy. The main limitation is the low intensity (i.e. protocol with fewer sessions and longer duration). These clinical limitations may explain the lack of evidence of a positive outcome. Following on from a preliminary study evaluating an intensive cervical traction protocol over five days, and in order to discern the effect specific to the treatment (specific effect) and the effect independent of the nature of the treatment (contextual effect), the investigators wish to evaluate the impact of this intensive protocol by comparing it with placebo traction. In current practice, treatment varies between establishments. The paucity of studies on cervical traction in radiculopathy has resulted in routine use being guided by habit rather than evidence. It remains a clinical question which raises a major issue requiring a robust experimental design. Ultimately, this study follows on from a preliminary study and is part of a comprehensive research project aimed at proposing new recommendations for the use of traction in patients suffering from cervical radiculopathy. The investigators are investigating the impact of an intensive traction vs. placebo traction protocol in patients with cervical radiculopathy.
CONDITIONS
Official Title
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy
Who Can Participate
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 four clinical signs of cervical radiculopathy: positive upper limb nerve tension test A (ULNT1a), cervical rotation less than 60 degrees on the affected side, positive cervical distraction test with symptom relief, positive Spurling test reproducing symptoms
- Cervical radiculopathy diagnosed between 3 and 24 months prior
- No cervical traction treatment in the 5 years before joining the study
- MRI or CT scan performed before hospitalization related to current condition
- Ability to understand the study protocol and provide oral informed consent
- Affiliated with social security or entitled beneficiary
You will not qualify if you...
- Vertebral artery disease 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 the past 2 years
- Participation in another clinical research study affecting this study's objectives
- Pregnancy, breastfeeding, or ability to conceive without effective contraception
- Under guardianship, curatorship, deprived of liberty, or under activated future protection mandate
- Under family habilitation or court protection
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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
Research Team
C
Chloé MOREAU
CONTACT
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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