Clinical trial NCT05952167: Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy
Official title: Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiculopathy
Cervical
Keywords: Cervical traction
Cervical radiculopathy
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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 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.

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.

Primary outcomes:
measure: Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3.
timeFrame: At 3 months post cervical traction protocol
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Limoges
country: France
facility: CHU Limoges
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: APHP La Pitié Salpêtrière
city: Reims
country: France
facility: Chu Reims
city: Rouen
country: France
facility: CHU Rouen
Study officials:
affiliation: Nantes University Hospital
name: Thomas RULLEAU
role: PRINCIPAL_INVESTIGATOR
References: