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RecruitingNCT05952167TracCerv2Updated Apr 15, 2026

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

An interventional study of Intensive cervical traction protocol and Intensive cervical traction protocol - placebo in Radiculopathy and Cervical, sponsored by Centre Hospitalier Departemental Vendee. Recruiting at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Centre Hospitalier Departemental Vendee · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Radiculopathy
  • Cervical

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Keywords

  • Cervical traction
  • Cervical radiculopathy
03

In context

Radiculopathy

483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.

This study's planned enrollment of 206 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 83 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 24 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 to take part in the research.
  • Patient affiliated to the social security system or entitled beneficiary.

Exclusion criteria

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 *.
  • Patient under guardianship, curatorship or deprived of liberty
  • Patient under activated future protection mandate
  • Patient under family habilitation
  • Patient under court protection.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
206 participants (estimated)

Study arms

  • Placebo comparator
    Placebo mechanical cervical traction

    Other: Intensive cervical traction protocol - placebo

  • Experimental
    Mechanical cervical traction

    Other: Intensive cervical traction protocol

Interventions

  • OtherIntensive cervical traction protocol

    2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected.

  • OtherIntensive cervical traction protocol - placebo

    2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: At 3 months post cervical traction protocol

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Study locations

7 of 8 sites recruiting
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References and documents

Publications

  • Cormier G, Moreau C, Scalisi E, Pastor L, Rulleau T. The effect of mechanical traction on cervical radiculopathy: protocol for the TracCerv2 single-blind, randomised controlled trial. BMC Complement Med Ther. 2025 Feb 14;25(1):56. doi: 10.1186/s12906-025-04801-5. PubMed 39953437 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05952167
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Jul 19, 2023
Start date
Mar 25, 2024
Primary completion
Dec 25, 2030 (estimated)
Completion
Sep 25, 2031 (estimated)
Last update
Apr 15, 2026

Study contacts

Chloé MOREAU
Contact
chloe.moreau@ght85.fr
0251446327 ext. +33
Thomas RULLEAU
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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