Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy

Radiculopathy Clinical Trial

— TracCerv2  

Official title:

Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05952167
• Other study ID #: CHD 22_0054
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: September 25, 2027

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Departemental Vendee
• Contact: Chloé MOREAU
• Phone: 0251446327
• Email: chloe.moreau[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: September 25, 2027
• Est. primary completion date: December 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 hospitalised during a week without public holidays.

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.

Related Conditions & MeSH terms

• Cervical
• Radiculopathy

Intervention

Other:
• Intensive cervical traction protocol
2x/day over 5 weekdays without public holidays
• Intensive cervical traction protocol - placebo
2x/day over 5 weekdays without public holidays

Locations

Country	Name	City	State
France	CHD Vendée	La Roche-sur-Yon
France	CH La Rochelle	La Rochelle
France	CH Emile Roux	Le Puy-en-Velay
France	CHU Limoges	Limoges
France	CHU Nantes	Nantes
France	APHP La Pitié Salpêtrière	Paris
France	CHU Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3.	The minimum clinically important difference (MCID) was established at 7 points out of 50 by (Cleland et al. 2006).	At 3 months post cervical traction protocol