Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05952167
Other study ID # CHD 22_0054
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03733886 - Burst Spinal Cord Stimulation for Neuropathic Pain. N/A
Completed NCT03835182 - Efficacy of Ultrasound Versus Short Wave Diathermy in the Treatment of a Slipped Disc of the Lower Back N/A
Completed NCT04169477 - Comparison of Two Modes of Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Neuropathic Radiculalgia N/A
Completed NCT02265848 - High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System Phase 4
Not yet recruiting NCT05487690 - Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries N/A
Recruiting NCT04909138 - Intermittent Dosing of Dorsal Root Ganglion Stimulation as an Alternate Paradigm to Continuous Low-Frequency Therapy N/A
Completed NCT05533723 - Comparison Between Endoscopic Epidural Neuroplasty and Percutaneous Epidural Neuroplasty in Low Back and Radicular Pain
Not yet recruiting NCT06041347 - Learning Curve for the Visualization of Sacral Plexus on TVS
Completed NCT02939482 - A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection N/A
Recruiting NCT05732818 - Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3 N/A
Active, not recruiting NCT04559295 - Bone Marrow Concentrate (BMC) Injection in Intervertebral Discs Phase 2/Phase 3
Completed NCT02644421 - Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica) Phase 1
Recruiting NCT06193265 - Management of Lumbar Discectomy by Endoscopy and Conventional Microscopic Discectomy
Recruiting NCT05145842 - The Effect of Combination of Ultrasound and Flouroscopy Guidance in Caudal Epidural Injections N/A
Withdrawn NCT03327272 - Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion Phase 3
Withdrawn NCT02196883 - Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other. N/A
Terminated NCT01850771 - Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy N/A
Completed NCT02130258 - Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome N/A
Withdrawn NCT05347108 - Real-Time Accurate Pathology Inspection and Decompression Study
Active, not recruiting NCT05696470 - Fusion Rates of 3D Printed Porous Titanium Cages in Three and Four Level ACDFs