Clinical trial NCT06669858: Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis
Official title: Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthrodesis
Post-operative Care
Manual Therapy
Lumbar Spine Surgery
Lead sponsor: Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
Sponsor class: OTHER
Collaborators: name: Institut de la Colonne Vertébrale Lyon Charcot
First posted: 2024-11-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the quality of life of patients. Objectives : To study the effectiveness of osteopathy in the post-surgical management of lumbo-sacral arthrodesis. Methods : A pilot study including 35 patients who underwent lumbo-sacral arthrodesis divided into 2 groups: standardized osteopathic treatment and sham. The protocol consists of 2 post-operative sessions (D2 3 and D90). The evaluated criteria were pain intensity using the VAS, functional disability with the Oswestry questionnaire, anxiety and depression with the HAD questionnaire, and analgesic consumption. Result : Compared to the sham group, the osteopathic treatment group exhibited a lack of significance in the VAS (p= NS), Oswestry (p= NS) and HAD (p= NS) scores. Analgesic consumption also demonstrated a lack of statistical significance (p= NS). Discussion : In this study, osteopathy did not show an impact on HAD, Oswestry, VAS scores, or analgesic consumption. Based on other articles, there seems to be a link between the effectiveness of osteopathy and the frequency of sessions. Thus, it might be interesting to repeat the study with a larger sample size, the use of other measurement tools, and an increase in session frequency to validate these results.


Eligibility criteria: Inclusion Criteria:

* having surgery in Institut de la Colonne Vertébrale
* surgery of lumbosacral arthrodesis

Exclusion Criteria:

* spine deformation
* inflammatory rhumatim
* neurodegenerative pathology
* cognitive trouble
* neoplasic pathology
* surgery complication
* second surgery
* out of the study

Primary outcomes:
measure: Analogic Visual Scale of pain
timeFrame: at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery
Secondary outcomes:
measure: OSWESTRY
timeFrame: day 0 pre surgery - day 90 post surgery - day 105 post surgery
measure: Hospital Anxiety and Depression
timeFrame: day 0 pre surgery, day 90 post surgery
measure: Antalgic consumption
timeFrame: from day 0 to day 105
Other outcomes:
Locations:
city: Ste Foy Les Lyons
country: France
facility: Institut de la Colonne Vertébrale Lyon Charcot
Study officials:
affiliation: Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
name: Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO
role: STUDY_DIRECTOR
affiliation: Institut de la Colonne Vertébrale Lyon Charcot
name: Pierre Grobost, PhD
role: STUDY_CHAIR
affiliation: Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
name: Aline Rollet, Ostéopathe DO, MsC Cand.
role: PRINCIPAL_INVESTIGATOR
References: