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

Study acronym: TracCerv2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Dec 25, 2026 to Dec 25, 2030
    • Study completion date: Sep 25, 2027 to Sep 25, 2031
    v14
  2. Minor Eligibility criteria revisedv13
  3. Minor Publications: details revised at 1 of 1 entryv12
  4. Minor Re-verified, no change to tracked fieldsv11
  5. Minor Site details revised at 1 of 8 sitesv10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Site details revised at 8 of 8 sitesv9
  2. Minor Study sites: 7 to 8v8
  3. Minor Eligibility criteria shortened, about 8 wordsv7
  4. Minor Primary completion date: Dec 1, 2026 to Dec 25, 2026
    • Study completion date: Sep 1, 2027 to Sep 25, 2027
    • Start date changed from estimate of Mar 1, 2024 to Mar 25, 2024
    v6
  5. Minor Primary completion date: Nov 1, 2026 to Dec 1, 2026
    • Study completion date: Aug 1, 2027 to Sep 1, 2027
    • Start date: Feb 1, 2024 to Mar 1, 2024
    • Site details revised at 2 of 7 sites
    v5
  6. Notable Start date: Jan 1, 2024 to Feb 1, 2024
    • Primary completion date: Oct 1, 2026 to Nov 1, 2026
    • Study completion date: Jul 1, 2027 to Aug 1, 2027
    • Site details revised at 2 of 7 sites
    v4
  7. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date: Oct 1, 2023 to Jan 1, 2024
    • Primary completion date: Jul 1, 2026 to Oct 1, 2026
    • Study completion date: Apr 1, 2027 to Jul 1, 2027
    • Site details revised at 7 of 7 sites
  8. Minor Study title shortened, about 7 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05952167
Lead Sponsor Centre Hospitalier Departemental Vendee
Conditions
(from sponsor)
Radiculopathy, Cervical
Related terms Radiculopathy
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov