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

NCT05952167 | Recruiting

• 1 other identifier: CHD 22_0054
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 8

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.

Conditions

Radiculopathy; Cervical

Keywords

Cervical traction; Cervical radiculopathy

Outcome Measures

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).

  At 3 months post cervical traction protocol

Study Arms (2)

Placebo mechanical cervical traction

PLACEBO COMPARATOR

Other: Intensive cervical traction protocol - placebo

Mechanical cervical traction

EXPERIMENTAL

Other: Intensive cervical traction protocol

Interventions

Intensive cervical traction protocol OTHER

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

Mechanical cervical traction

Intensive cervical traction protocol - placebo OTHER

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

Placebo mechanical cervical traction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (8)

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

CH La Rochelle

La Rochelle, France

RECRUITING

CH Emile Roux

Le Puy-en-Velay, France

TERMINATED

CHU Limoges

Limoges, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

APHP La Pitié Salpêtrière

Paris, France

RECRUITING

Chu Reims

Reims, France

RECRUITING

CHU Rouen

Rouen, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39953437 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Thomas RULLEAU

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé MOREAU

CONTACT

0251446327; chloe.moreau@ght85.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 25, 2030
• Study Completion (Estimated): September 25, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)