The effect of mechanical traction on cervical radiculopathy: protocol for the TracCerv2 single-blind, randomised controlled trial

The Impact of Mechanical Traction on Cervical Radiculopathy

Study Overview

This study aims to assess how effective a specific cervical traction treatment is for people suffering from cervical radiculopathy after 3 months compared to a placebo treatment.

Key Details

  • Study Type: National, multi-centre, single-blind, randomised controlled trial.
  • Timeline: Conducted from March 2024 to September 2027.
  • Locations: Seven hospitals across France.

Participants

We will include 206 adults aged 18 and older, diagnosed with cervical radiculopathy for 3 to 12 months. Participants must have a Neck Disability Index score of at least 15 out of 50 and show at least 3 out of 4 diagnostic signs.

Treatment Protocol

Participants will undergo:

  • 2 sessions of 30 minutes of traction each day for 5 days.
  • Mechanical traction with a maximum weight of 12 kg or placebo traction with a maximum of 600 grams.

Outcome Measures

The main focus is on measuring disability through the Neck Disability Index. Secondary outcomes will assess pain levels, medication use, surgical needs, and time off work.

Expected Results

This study will provide valuable insights into how effective mechanical traction is for reducing disability and pain in chronic cervical radiculopathy. It will help determine if this simple treatment is beneficial in the long term.

Conclusion

Findings from this trial will help clarify whether cervical traction is a useful treatment option. This can lead to improved treatment guidelines for managing cervical radiculopathy.

Clinical Trial Registration

ClinicalTrials.gov (NCT05952167)

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