Intensive care by osteopathy for victims of road traffic accidents (RTA) (AIVIO: Aide Intensive aux Victimes dAccident de la Voie Publique (AVP) par Ostéopathie)

ISRCTN	ISRCTN46623132
DOI	https://doi.org/10.1186/ISRCTN46623132
Protocol serial number	AIVIO/CHNDRF/0708
Sponsor	Catholic University of Louvain (Université Catholique de Louvain) (Belgium)
Funder	Investigator initiated and funded (Belgium)

Submission date: 24/03/2011
Registration date: 19/05/2011
Last edited: 19/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chantal Ropars
Scientific

99, rue du Petit Château
Charenton Le Pont
94220
France

Study information

Primary study design	Interventional
Study design	Single centre pilot prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Intensive care by osteopathy for victims of road traffic accidents (RTA) (AIVIO: Aide Intensive aux Victimes dAccident de la Voie Publique (AVP) par Ostéopathie): a single centre, pilot, prospective, randomised controlled trial
Study acronym	AIVIO (Aide Intensive aux VIctimes par Ostéopathie)
Study objectives	1. The sensory stimuli developed by functional osteopathy technique are thought to produce similar effects to sensory stimuli used in eye movement desensitisation and reprocessing (EMDR), inducing the same ponto-geniculo-occipital (PGO) waves that potentially activate the transfer of hippocampal traumatic memory information to the semantic cortex. 2. Functional osteopathy appears to produce additional therapeutic mechanisms: somatic work appears to reactivate cell assemblies, useful when verbal reconstruction is difficult or impossible. Without verbal induction, recall occurs when psychic resistance lowers, protecting fragile victims from potential depressive or psychotic decompensation. The tactile dialogue is respectful of the bodys resistance and in this manner rapidly leads to a feeling of security, narcissistic reassurance and peaceful dissociation. These elements of the therapeutic context bring about recall of the traumatic information without anxiety, further eliminating avoidance strategies which maintain post-traumatic stress disorder (PTSD). 3. Finally, myofascial tensions acquired from the accident (whiplash in particular) potentially contribute to neurovegetative disorders, to sensitisation of the hypothalamic-pituitary adrenal axis (HPA) and to persistent pain. Eliminating these mechanical tensions relieves muscular skeletal pain, itself having the potential to produce catecholaminergic and glutamatergic disorders. 4. The psychic and physical action of functional osteopathy could thus potentially contribute to regulating pathognomonically low cortisol levels of PTSD.
Ethics approval(s)	1. Ethics Committee of the Clinical Psychology Research Unit of the UCL (Université Catholique de Louvain) approved on 22nd March 2006. 2. Ethics Committee of the hospital, CHNDRF of Charleroi (Belgium) approved on 20th June 2006, ref: OM/100
Health condition(s) or problem(s) studied	Post-traumatic stress disorder
Intervention	Treatment group 1: trauma victims (11 people), two men aged between 49 and 51 and nine women aged between 25 and 56. Treatment involving 10 sessions of functional osteopathy, of one hour each, spaced a minimum of 15 days apart. As opposed to structural osteopathy which seeks to restore skeletal alignment by what is known as high velocity and low amplitude cracking and manipulations of the joints, the mode of action of functional osteopathy is to retrace the lesion without irritation by way of meticulous adjustment of the connective tissue (including musculoskeletal structures) to balance tensions. While structural osteopathy may be described in easily identifiable and specific techniques, the functional approach relies on a true tactical dialogue with the tissues. Once the therapist has brought the tense tissues to their position of least tension in the three dimensions of space (front/back, right/left, superficial/deep), these myofascial structures release tension which the osteopath and often times the patient can perceive. Control group 2: RTA victims on the waiting list, three women between 23 and 63 Control group 3: Young volunteers in good health and with no anxiety disorders, four women aged 23 to 30. Serious stress events affected three of them during the research study.
Intervention type	Other
Primary outcome measure(s)	1. Post-traumatic Stress Disorder Checklist Scale (PCLS) 2. Salivary cortisol (IBL - AMERICA Salivary Cortisol HS ELISA Kit, a solid phase enzyme-linked immunosorbent assay based on the principle of competitive binding), measured twice a day for the 28 days before and after the treatment
Key secondary outcome measure(s)	1. Quality of life (Medical Outcome Survey SF-36) meassured at each session 2. Pain: EVA and the item bodily pain (MOS SF-36) measured at each session 3. Heart rate measured at each session 4. Dissociation (Dissociative Experience Scale - DES) measured once before and once after the treatment 5. Depression (Beck depression Inventory 21) measured once before and once after the treatment 6. Non traumatic anxiety disorders (phobic disorders, panic attacks, generalized anxiety scale - PPGA) measured once before and once after the treatment 7. Alexithymia (Bermond and Vorst Alexithymia Questionnaire- BVAQ) measured once before and once after the treatment
Completion date	17/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Recent road traffic accident victims 2. Positive test for PTSD (PCLS>44) over 6 months after the RTA 3. Accept saliva tests: 2 daily saliva samples, one on waking and the other 30 minutes after the first, on an empty stomach and without having smoked or brushed teeth. Over a period of 28 days before and after treatment
Key exclusion criteria	1. People under 18 years of age 2. People under pretraumatic corticotherapy 3. People whose alcohol consumption regularly exceeds two glasses for women or three glasses for men 4. People who did not provide the saliva samples
Date of first enrolment	01/03/2007
Date of final enrolment	17/12/2008

Locations

Countries of recruitment

Belgium
France

Study participating centre

99, rue du Petit Château

Charenton Le Pont
94220
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Intensive care by osteopathy for victims of road traffic accidents (RTA) (AIVIO: Aide Intensive aux Victimes dAccident de la Voie Publique (AVP) par Ostéopathie)