- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06357715
Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People (SPEAKER 2)
Effectiveness of Neurodynamic Sliding Mobilisation in the "Slump" Position in Relation to the Perceptible Pain Threshold in Asymptomatic People, a Cross-over Randomised Controlled Trial
According to the French National Health Agency, the use of manual therapy techniques is "possible" [grade B] as part of a multimodal combination of treatments for low back pain. These include so-called "neurodynamic" neural mobilisations, which aim in particular to desensitise the pain system and activate descending inhibitory pathways, with effects on pain and function in patients with nerve-related low back pain. Most of the available evidence does not explain the mechanisms involved in neural mobilisation in the slump position. Pain reduction is observed in more areas of the body with sliding techniques than with traction techniques.
In this cross-over, randomised controlled trial, we therefore hypothesise that the neurodynamic sliding technique in the slump position acts on mechanisms linked to central pain modulation processes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: timothée GILLOT, PhD
- Phone Number: +33 0232880671
- Email: timothee.gillot@chu-rouen.fr
Study Contact Backup
- Name: deborah lebedieff
- Email: deborah.lebedieff@chu-rouen.fr
Study Locations
-
-
-
Rouen, France, 76000
- Recruiting
- Centre d'investigation clinique CIC ROUEN
-
Principal Investigator:
- Timothée GILLOT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Subjects aged 30 years or older and less than 65 years;
- Subjects considered naive to neurodynamic mobilisation techniques;
- Volunteers who have read and understood the information letter and have given their written consent to participate in the study;
- Fluent in spoken and read French;
- Effective contraception in women of childbearing age (progestin-only or intrauterine device or tubal ligation) for at least 12 months;
- For postmenopausal women, a confirmatory diagnosis must be obtained (non-drug-induced amenorrhoea for at least 12 months prior to the enrolment visit);
- Subject affiliated to a social security scheme.
Exclusion Criteria:
- Positive slump test on the day of the selection visit (production of asymmetric lumbar symptoms or painful radiations in at least one lower limb or unilateral reduction in physiological knee extension range of motion compared with the contralateral side);
- Neurological and neuropathic pain assessment score (DN4) greater than 4;
- Increase or decrease in sensory function in the lower limb compared with the contralateral side, as measured by Clinical Sensory Testing (CST);
- Any physical exertion of perceived intensity greater than 17 on the Borg 6-20 scale in the 72 hours prior to the trial and during the trial;
- Injury, complaint or symptom affecting the spine (cervical, thoracic, lumbar) and/or lower limb(s) requiring absence from work, school or leisure activities in the 12 months prior to enrolment;
- History of major surgery, injury to the trunk, spine and/or lower limb(s), or history of progressive rheumatic, neurological or oncological pathology;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: neurodynamic sliding mobilisation in the "Slump" position
"slump"position
|
neurodynamic sliding mobilisation in the "slump" position
placebo
|
|
Placebo Comparator: mobilisation, out of the "Slump" position
no "slump"position
|
neurodynamic sliding mobilisation in the "slump" position
placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in pressure at the moment when the volunteer indicates that the sensation of pressure becomes pain
Time Frame: immediately after the mobilisation and 1 day after the mobilisation
|
Difference in pressure exerted on the territory of the sciatic nerve (gluteal region) at the moment when the volunteer indicates that the sensation of pressure becomes pain, on the dominant lower limb, between the same volunteer during two treatment sessions which differ only in the exposure to neurodynamic sliding mobilisation in the "Slump" position or to mobilisation outside the "Slump" position.
|
immediately after the mobilisation and 1 day after the mobilisation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/0373/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Voluntary
-
University of Alabama at BirminghamCentre for Infectious Disease Research in ZambiaCompletedVoluntary Medical Male CircumcisionZambia
-
University Hospital, CaenNovespaceUnknown
-
University of North Carolina, Chapel HillBill and Melinda Gates Foundation; FHI 360; Impact Research & Development OrganizationCompletedVoluntary Medical Male Circumcision | Circumcision AdultKenya
-
University of WashingtonNational Institute of Nursing Research (NINR); Aurum InstituteCompletedVoluntary Medical Male CircumcisionSouth Africa
-
University of WashingtonUniversity of Zimbabwe; Medic Mobile; International Training and Education Center... and other collaboratorsCompletedVoluntary Medical Male CircumcisionZimbabwe
-
Centre Hospitalier Universitaire DijonRecruitingMedical Termination of Pregnancy | Voluntary Termination of PregnancyFrance
-
University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network; University... and other collaboratorsCompletedECG-PCG-CTG Acquisition on Pregnant Voluntary SubjectsFrance
-
University of Southern CaliforniaCompletedNon-disabled Volunteers | Lacking Voluntary Control of Ear MusclesUnited States
-
University Hospital, ToulouseCompletedVoluntary Termination of PregnancyFrance
-
University Hospital, ToulouseWithdrawnVoluntary Termination of Pregnancy
Clinical Trials on "slump"position
-
University Hospital, RouenUnknown
-
European University of LefkeCompletedLow Back Pain | SciaticaPalestinian Territory, occupied
-
Jouf UniversityCairo University; Olfat Ibrahim Ali; Alaa Mohamed Al abbas; Sara Hamed ElzareaCompletedMusculoskeletal Diseases or ConditionsEgypt
-
Isra UniversityUnknown
-
National University Hospital, SingaporeTerminatedLow Back Pain | Spondylolisthesis
-
Foundation University IslamabadRecruitingLow Back Pain, MechanicalPakistan
-
Foundation University IslamabadActive, not recruiting
-
Sahreen AnwarRecruiting
-
University of HartfordCompleted
-
Çanakkale Onsekiz Mart UniversityCompletedPosition | Comfort | Newborn, Infant, Disease | ResidualTurkey