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Status unknownNCT03382236IPODEUpdated Dec 22, 2017

Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People

An interventional study of osteopathy in Osteopathy, sponsored by Léa Gouaux. Status unknown at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.

Sponsored by Léa Gouaux · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study summary

This type of study can have an impact on public health policy and help improve the management of pain in people with EHPAD; Propose better use of drug treatments and non-pharmacological methods such as osteopathy; Help structuring the healthcare sector.

Read the detailed description
  • "Osteopathy" group: 3 osteopathy sessions of 45 min with one session every 3 weeks at S2, S5 and S8. Fascial osteopathic techniques performed will consist of gentle and non-impulsive manipulation
  • "Simulated" group: 3 simulated osteopathy sessions lasting 45 minutes, one session every 3 weeks at S2, S5 and S8. The techniques performed will consist of an application of the hands to different anatomical regions than the group "osteopathy" without therapeutic intention, that is to say without tissue tensioning.

The pain will be assessed at inclusion (S0) and at the end of the procedure (S12) by the head physician, the coordinating physician or the psychomotor therapist, ignoring the assignment group of the subject and before each session. osteopathy (at S2, S5 and S8) by a nurse or psychomotor also ignoring the patient's assignment group.

Both groups will continue to benefit from their usual allopathic management and recommendations.

Patients will not be aware of the treatment received (osteopathy or simulated) and will be randomized by a computer server.

02

Conditions studied

  • Osteopathy
03

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients older than 75 years
  • Patients Residing in Accommodation Facilities for Dependent Old People
  • A score measured by the DOLOPLUS 2 Scale at least 7/30 at the start of the study
  • For patients in capacity and autonomous: Patients informed and having signed a free and informed consent.

For non-capable patients with a trusted person and / or guardian: Informed patients whose confidant or guardian has been informed and has signed free and informed consent.

  • Affiliated to a social security scheme (beneficiary or beneficiary)

Exclusion criteria

Exclusion Criteria:

  • Absence of pain
  • Medical contraindication known to the practice of osteopathy with fascial aim (advanced degenerative bone disease, metastatic cancer)
  • Osteopathic treatment in the last six months
  • Patients under curators
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Real osteopathy

    Other: osteopathy

  • Placebo comparator
    Sham osteopathy

    Other: osteopathy

Interventions

  • Otherosteopathy

    osteopathic techniques

05

What researchers measure

Primary outcomes

  1. DOLOPLUS 2 score

    Assessment of pain assessed by the behavioral scale

    Time frame: Every week after inclusion during 4 weeks

06

Study locations

1 of 1 sites recruiting
  • Lea Gouaux
    Paris, Ile De France 77420, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03382236
Lead sponsor
Léa Gouaux
Collaborators
BTP RMS, ESO Paris Recherche
Responsible party
Léa Gouaux (Attachée de recherche clinique, Ecole Supérieur d'Ostéopathie) — Sponsor-investigator
First posted
Dec 22, 2017
Start date
Jan 3, 2017
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Dec 22, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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