OsteopathyIPODENCT03382236
Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People
A study testing osteopathy in people with Osteopathy, run by Léa Gouaux at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Osteopathy
- What is being tested?
- osteopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Lea Gouaux
Paris, Île-de-France Region, 77420
Gouaux Lea, 0614315262, arc@eso-recher.fr
About this study
Official title: Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People in Residential Care Facilities for the Elderly (EHPAD)
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.
- Conditions
- Osteopathy
- Being tested
- osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathyOther
osteopathic techniques
| Study group | Role | What they receive |
|---|---|---|
| Real osteopathy | Experimental | Not described Receives: Other: osteopathy |
| Sham osteopathy | Placebo comparator | Not described Receives: Other: osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DOLOPLUS 2 score
Assessment of pain assessed by the behavioral scale
Measured: Every week after inclusion during 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start3 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopathyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Léa Gouaux
- Sponsor type
- University, hospital or other
- Collaborators
- BTP RMS, ESO Paris Recherche
- Responsible party
- Sponsor-investigator, Léa Gouaux, Ecole Supérieur d'Ostéopathie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382236
- Sponsor's protocol ID
- BTP RMS
- Acronym
- IPODE
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People in Residential Care Facilities for the Elderly (EHPAD)
- ClinicalTrials.gov ID
- NCT03382236
- Acronym / sponsor ID
- IPODE / BTP RMS
- Conditions
- Osteopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Léa GouauxUniversity, hospital or other
- Collaborators
- BTP RMS, ESO Paris Recherche
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 22 Dec 2017 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real osteopathy | Experimental | Other: osteopathy |
| Sham osteopathy | Placebo comparator | Other: osteopathy |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| osteopathyosteopathic techniques | Other | Real osteopathy, Sham osteopathy |
Primary outcome
DOLOPLUS 2 score
Time frame: Every week after inclusion during 4 weeks
Assessment of pain assessed by the behavioral scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathy in people with Osteopathy, run by Léa Gouaux at 1 site 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DOLOPLUS 2 score (time frame: Every week after inclusion during 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2017.