RadiculopathyTracCerv2NCT05952167
Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy
A study testing Intensive cervical traction protocol in people with Radiculopathy and Cervical, run by Centre Hospitalier Departemental Vendee at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy, Cervical
- What is being tested?
- Intensive cervical traction protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 8 sitesFrance
- Study dates
- 25 Mar 2024to 25 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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 informed consent to take part in the research.
- Patient affiliated to the social security system or entitled beneficiary.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 7 recruiting
- Recruiting
CHD Vendée
La Roche-sur-Yon
Grégoire CORMIER
- Recruiting
CH La Rochelle
La Rochelle
Ludivine LAURENT
- Terminated
CH Emile Roux
Le Puy-en-Velay
- Recruiting
CHU Limoges
Limoges
Julien COLLIN
- Recruiting
CHU Nantes
Nantes
Joelle GLEMAREC
- Recruiting
APHP La Pitié Salpêtrière
Paris
Bruno FAUTREL
- Recruiting
Chu Reims
Reims
Jean-Hugues SALMON
- Recruiting
CHU Rouen
Rouen
Timotheé GILLOT
About this study
Official title: Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study
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.
Read more
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
- Being tested
- Intensive cervical traction protocol, Intensive cervical traction protocol - placebo
- Keywords
- Cervical traction, Cervical radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive cervical traction protocolOther
2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected.
Intensive cervical traction protocol - placeboOther
2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected.
| Study group | Role | What they receive |
|---|---|---|
| Placebo mechanical cervical traction | Placebo comparator | Not described Receives: Other: Intensive cervical traction protocol - placebo |
| Mechanical cervical traction | Experimental | Not described Receives: Other: Intensive cervical traction protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 3 months post cervical traction protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start25 Mar 2024
- Primary completion25 Dec 2030 (estimated)
- Study completion25 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas RULLEAU, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952167
- Sponsor's protocol ID
- CHD 22_0054
- Acronym
- TracCerv2
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study
- ClinicalTrials.gov ID
- NCT05952167
- Acronym / sponsor ID
- TracCerv2 / CHD 22_0054
- Conditions
- Radiculopathy, Cervical
- Keywords
- Cervical traction, Cervical radiculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Dec 2030 (estimated)
- Study completion
- 25 Sep 2031 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo mechanical cervical traction | Placebo comparator | Other: Intensive cervical traction protocol - placebo |
| Mechanical cervical traction | Experimental | Other: Intensive cervical traction protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
- Cervical radiculopathy diagnosed 3 to 24 months previously
- Absence of cervical traction in the 5 years prior to inclusion
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive cervical traction protocol2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected. | Other | Mechanical cervical traction |
| Intensive cervical traction protocol - placebo2x/day over 5 weekdays A minimum of 8 pull-ups over 5 consecutive days is expected. | Other | Placebo mechanical cervical traction |
Primary outcome
Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3.
Time frame: At 3 months post cervical traction protocol
The minimum clinically important difference (MCID) was established at 7 points out of 50 by (Cleland et al. 2006).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 39953437Cormier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas RULLEAU principal investigator
Nantes University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive cervical traction protocol in people with Radiculopathy and Cervical, run by Centre Hospitalier Departemental Vendee at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé MOREAU (0251446327 ext. +33, chloe.moreau@ght85.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3. (time frame: At 3 months post cervical traction protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.