Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02584049 |
| Other study ID # |
CHRD0215 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2, 2015 |
| Est. completion date |
January 31, 2018 |
Study information
| Verified date |
July 2023 |
| Source |
Centre Hospitalier René Dubos |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate effects of Osteopathic Treatment in the Management
of Care-induced pain in Elderly care, in Follow-up care and Rehabilitation Geriatric.
The investigators assume that the application of a procedure based on osteopathic fascial
techniques in elderly care in Suite and Geriatric Rehabilitation ( SSRG ) suffering from pain
of nursing care, could reduce the painful phenomenon having systemic action, and improve
tissue engineering, trophicity viscera and the neurovascular supply .
Description:
The prevalence of pain in the elderly is very important, especially for people living in
institutions ( 40-70 % according to recent studies). Among the most common complaints include
pain induced by treatments. It is defined by Upsa Laboratory as pain of "short duration
caused by the caregiver in the foreseeable occurrence of circumstances and can be prevented
by suitable measures ." Responsible care are induced pain dressings, levies and other
diagnostics actions, mobilizations during an exchange , a toilet, a transfer between
different services or an act of rehabilitation. The repetition of acts and therefore the pain
, is also a source of anxiety for older people who often have to anticipate the following
treatments , and thus hinder the care relationship.
The evaluation of the induced pain is a growing concern for all caregivers. It concerns all
the players care, medical or paramedical.
Prevention and relief of pain induced is part of regulatory obligations become since the Law
of 4 March 2002 on patients' rights and quality of the health system. It is in this dynamic,
in 2006 the Ministry of Health and Solidarity launched a support plan to improve the pain,
one of whose objectives was to promote the quality of life of older people reducing the
impact of pain on daily life.
To assess pain in seniors several scales are listed and validated: ECPA scale that allows the
evaluation of recurrent pain induced pain and is used in some service of Suite and Geriatric
Rehabilitation (SSRG); Doloplus scale is more suitable for evaluation of chronic pain and
finally Algoplus scale specialized in the evaluation of acute pain. The pain assessment
difficulties in the elderly are also accentuated by the many possible etiologies, the
fatalistic attitude of some and the belief that pain is part of a normal aging process.
It is therefore to identify the intensity of the pain, its characteristics and causes to
guide treatment. The pain relief will be based on non-drug means (prevention, care
explanation, hypnosis, massage, cryotherapy), and / or medication when analgesia is no longer
sufficient. Drug treatment, however, have the disadvantage of frequent side effects and be
difficult to use in the elderly already poly medicated. Non-drug therapies, they can help
limit the requirements, and therefore their side effects, and as such are to be considered in
addition to usual care.
Osteopathy is a holistic manual medicine that aims to prevent and remedy various functional
disorders of the body. This discipline has a wide scope whose positive influence was
demonstrated on particular musculoskeletal pain type of neck pain, back pain, visceral on as
chronic constipation, gastric reflux, migraines, or back pain chronic in the elderly in
institutions.
This study's main objective is to determine through a randomized controlled clinical trial,
the efficacy of osteopathy on the reduction of pain induced in the elderly in institutions.
This type of study can have an impact on public health policy and help improve :
- the treatment of pain induced in people SSRG ;
- propose a better use of medication and non-pharmacological methods like osteopathy ;
- assist in structuring the health care sector.
The public will be randomized using a block randomization, into two groups: a "osteopathy"
group and a "simulated" group (simulated techniques).
Both procedures will not be provided by the same operator. Two exclusive osteopathic will
load groups "osteopathy" and "simulated" according to randomization to be set so as to ensure
a random distribution of the groups, that is to say, each operator will be as many patients
that simulated .
Service nurses will be in charge of data collection, blind, that is to say that they have
knowledge that the patient is included in the study but not the membership group. This
methodology will allow us as well to justify the contribution of osteopathy in relation to
the natural course of the patient's health status, and to justify the contribution of
osteopathy regardless of the operator. Operators will support different patients included in
the study in the same way, regardless of their allocation group. Thus, it will be applied a
standardized osteopathic and simulated procedure (described above) and the same attitude of
support from operators. Including verbal exchanges will be the same, addressing different
areas of the patient, whether medical, family, or professional. The goal is to ensure some
standardization in the management, which standardizes the simulated treatment and making it
look like at any point in the care osteopathic. For the sake of continuity of treatment, it
is "osteopathic" or "simulated" the operator assigned after randomization will perform the 3
sessions with the same patient.
-Group " osteopathy ": an osteopathic fascial only procedure will be used , having no
technique called " impulsive " (or Thrust technique during which the patient may hear a
cracking sound ) . This approach therefore does not present any particular risk of side
effects for the patient.
Specifically , the following techniques will be applied by the operator in order that wish
to: A technical on (or) scar (s)
- Technical overall equilibration of the upper limbs
- Technical overall equilibration of the lower limbs
- A basic technique spread
- Technical C0 of equilibration relative to the sternum
- A technique of diaphragmatic equilibration
- A fascial technique on dorsal vertebrae and / or lumbar
At protocol performed for osteopathy group will be assigned to each area addressed by each
technique a coefficient of osteopathic dysfunction assessed in this way:
- Lack of dysfunction, coefficient 0
- low Dysfunction, coefficient equal to 1
- moderate dysfunction, coefficient equal to 2
- strong Dysfunction, coefficient equal to 3 These coefficients will be recorded in a
table at each meeting and will allow the operator to monitor the patient own
dysfunctional pattern.
- Group " simulated ": The simulated protocol similar to that used in the study of John C.
Licciardone et al. and validated by North Texas Chronic Low Back Pain Trial , is
performed in the same positions as the care osteopathic . The operator places his hands
on the same areas , avoiding associated mobilize joints and muscles.
Both procedures " osteopathic " and "simulated" , will be provided in three sessions lasting
60 minutes each, one week apart . The interval of one week is justified by the fact that the
nursing care can be repeated several times a day , and the constraints of prolonged bed rest
being permanent , the tissues of patients are found in an advanced state of fibrosis . It
then seems necessary to allow an integration time between sessions. The choice of 3 sessions
is based on a compromise between feasibility in the service, acceptability for the patient
and the investigators' assessment of the optimal intensity of the procedure. Week 4 , only a
data collection will be realized.
