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PainOGéDISNCT02584049

Osteopathic Medicine in the Management of Care-induced Pain in Elderly Care (OGéDIS)

A study testing Osteopathy in people with Pain, run by Hôpital NOVO at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Pain
What is being tested?
Osteopathy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
2 sitesFrance
Study dates
2 Dec 2015to 31 Jan 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 aged over 75 years ;
  • Patients residing in Suite Care service and Geriatric Rehabilitation with pain induced by the nursing care;
  • Pain intensity measured by the Behavioral Assessment Scale of pain in the Aged Person ( ECPA) at least 8/32 within five days before the start of the study;
  • Patients having informed and signed a free and informed consent ;
  • Affiliated to social security scheme (beneficiary or assignee ) .

Who cannot join

  • Medical contraindication to the practice of osteopathy ;
  • Osteopathic treatment during the past year ;
  • Patients under tutorship and curatorship .

Trial locations and contacts

2 sites in 1 country.

France2 sites
  • Intercommunal Hospital Group of Vexin - Geriatric care and rehabilitation department

    Marines, 95640

  • René Dubos Hospital - Geriatric care and rehabilitation department

    Pontoise, Île-de-France Region, 95303

Other trials in France

About this study

Official title: Effects of Osteopathic Treatment in the Management of Care-induced Pain in Elderly Care, in Follow-up Care and Rehabilitation Geriatric

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 .

Read the detailed 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.

Conditions
Pain
Being tested
Osteopathy, Sham osteopathy
Keywords
Osteopathic treatment, Care-induced Pain, Pain, Elderly
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsteopathyOther

    3 sessions of osteopathy during 60 minutes each

  • Sham osteopathyOther

    3 sessions of sham osteopathy during 60 minutes each

Study groups in NCT02584049
Study groupRoleWhat they receive
OsteopathyActive comparator3 sessions of Osteopathic treatment in addition to the usual follow
Receives: Other: Osteopathy
Sham osteopathySham comparator3 sessions of Sham osteopathy treatment in addition to the usual follow
Receives: Other: Sham osteopathy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Care-induced Pain assessed by Behavioural Scale

    Behavioural Scale to Evaluate Pain in Non-communicating Adults (ECPA)

    Measured: Every week after inclusion during 4 weeks

Secondary outcomes (2)
  1. Evaluation of variation in the Consumption of Analgesics (frequency, dose, type)

    Consumption of analgesics will be measured with the name of drug, the frequency and the dose Measure : Comparison of analgesic consumption before and after 3 sessions of osteopathy ( between S0 and S4) : increase or decrease the frequency, dose or type

    Measured: Every day from inclusion during 4 weeks

  2. Evaluation of Pain

    Visual Analog Scale (VAS) for communicating Adults or Algoplus Scale for non-communicating Adults

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2015 (estimated)
  2. Study start2 Dec 2015
  3. Primary completion31 Jan 2018
  4. Study completion31 Jan 2018

Why it stopped: The study was stopped prematurely because of the low inclusion rate (1 inclusion in 16 months), the low patient potential and the difficulty of finding new recruiting centres.

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584049
Sponsor's protocol ID
CHRD0215
Acronym
OGéDIS
Status last verified
Jul 2023
First submitted
20 Oct 2015
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathy in people with Pain, run by Hôpital NOVO at 2 sites 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study was stopped early (reason given: The study was stopped prematurely because of the low inclusion rate (1 inclusion in 16 months), the low patient potential and the difficulty of finding new recruiting centres.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Care-induced Pain assessed by Behavioural Scale (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 7 Jul 2023.

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