NCT06357715

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Oct 2024Nov 2026

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 23, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2026

Last Updated

May 7, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

April 4, 2024

Last Update Submit

May 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Difference in pressure at the moment when the volunteer indicates that the sensation of pressure becomes pain

    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

Study Arms (2)

neurodynamic sliding mobilisation in the "Slump" position

ACTIVE COMPARATOR

"slump"position

Other: "slump"positionOther: no" slump" position

mobilisation, out of the "Slump" position

PLACEBO COMPARATOR

no "slump"position

Other: "slump"positionOther: no" slump" position

Interventions

neurodynamic sliding mobilisation in the "slump" position

mobilisation, out of the "Slump" positionneurodynamic sliding mobilisation in the "Slump" position

placebo

mobilisation, out of the "Slump" positionneurodynamic sliding mobilisation in the "Slump" position

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'investigation clinique CIC ROUEN

Rouen, 76000, France

RECRUITING

Central Study Contacts

timothée GILLOT, PhD

CONTACT

deborah lebedieff

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the second physiotherapist who evaluate the pressure pain
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

October 23, 2024

Primary Completion (Estimated)

November 6, 2026

Study Completion (Estimated)

November 6, 2026

Last Updated

May 7, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations