Informations générales (source: ClinicalTrials.gov)
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study (TracCerv2)
Interventional
N/A
Centre Hospitalier Departemental Vendee (Voir sur ClinicalTrials)
mars 2024
septembre 2027
10 mai 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| APHP La Pitié Salpêtrière - Paris - France | Contact (sur clinicalTrials) | ||||
| CH Emile Roux - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| CH La Rochelle - La Rochelle - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHU Limoges - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - Nantes - France | Contact (sur clinicalTrials) | ||||
| Chu Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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 12 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.
- 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 12 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.
- 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.