CompletedNot Applicable

Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain

France42 participantsStarted 2020-11-16

Plain-language summary

The main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of Blueback® Physio compared to a rehabilitation without the use of Blueback® Physio in terms of reducing the time needed for a patient to control the voluntary contraction of the transversus abdominal muscle and to return to autonomy.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Included in the PRESDO program, * Suffering from chronic low back pain (= low back pain installed for more than 2 months), * Beneficiary of a social security, * For which his consent has been obtained in writing with regard to his participation in the protocol. Exclusion Criteria: * Bedridden or using a wheelchair, * Having a contraindication to performing the muscular exercises provided for in the protocol, * Having any other condition which, in the opinion of healthcare professionals, could affect its ability to complete the study or could present a significant risk, * Simultaneously participating in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed.

What they're measuring

Time needed to master the motor control of the muscle (in number of rehabilitation sessions)

Timeframe: 5 weeks including 5 rehabilitation sessions per week

Trial details

NCT IDNCT04592094

SponsorBlueback

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-07

View on ClinicalTrials.gov More Low Back Pain, Recurrent trials