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.
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
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 group | Role | What they receive |
|---|---|---|
| Osteopathy | Active comparator | 3 sessions of Osteopathic treatment in addition to the usual follow Receives: Other: Osteopathy |
| Sham osteopathy | Sham comparator | 3 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.
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)
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
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.
- First posted22 Oct 2015 (estimated)
- Study start2 Dec 2015
- Primary completion31 Jan 2018
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Collaborators
- ESO Paris Recherche
- Responsible party
- Sponsor
- Investigators
- Martine MERCERON, PH, Principal investigator, René Dubos Hospital (PONTOISE-FRANCE)
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Treatment in the Management of Care-induced Pain in Elderly Care, in Follow-up Care and Rehabilitation Geriatric
- ClinicalTrials.gov ID
- NCT02584049
- Acronym / sponsor ID
- OGéDIS / CHRD0215
- Conditions
- Pain
- Keywords
- Osteopathic treatment, Care-induced Pain, Pain, Elderly
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Collaborators
- ESO Paris Recherche
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 22 Oct 2015 (estimated)
- 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.
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 .
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathy | Active comparator | Other: Osteopathy3 sessions of Osteopathic treatment in addition to the usual follow |
| Sham osteopathy | Sham comparator | Other: Sham osteopathy3 sessions of Sham osteopathy treatment in addition to the usual follow |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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 ) .
Key exclusion criteria (3 listed)
- Medical contraindication to the practice of osteopathy ;
- Osteopathic treatment during the past year ;
- Patients under tutorship and curatorship .
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 |
|---|---|---|
| Osteopathy3 sessions of osteopathy during 60 minutes each | Other | Osteopathy |
| Sham osteopathy3 sessions of sham osteopathy during 60 minutes each | Other | Sham osteopathy |
Primary outcome
Evaluation of Care-induced Pain assessed by Behavioural Scale
Time frame: Every week after inclusion during 4 weeks
Behavioural Scale to Evaluate Pain in Non-communicating Adults (ECPA)
2 secondary outcomes
Evaluation of variation in the Consumption of Analgesics (frequency, dose, type)
Time frame: Every day from inclusion during 4 weeks
Evaluation of Pain
Time frame: 4 weeks
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Martine MERCERON, PH principal investigator
René Dubos Hospital (PONTOISE-FRANCE)
2 sites 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 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; AzTrials last refreshed its copy on 8 Nov 2026.