Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis

Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Arthrodesis; Post-operative Care; Manual Therapy; Lumbar Spine Surgery
• Intervention / Treatment: Other: manual therapy; Other: Sham

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Ste Foy Les Lyons, France, 69110
    • Institut de la Colonne Vertébrale Lyon Charcot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual therapy standardized protocol group; This arm received 2 session of manual therapy (standardized protocol) 2-4 days after surgery and 90 days after surgery	Other: manual therapy; In first session 6 techniques were applied to favorise fluids circulation, respiratory mecanism end equilibration of pressions (all were external soft tissue techniques, without manipulation): on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on liver and spleen organ, on lumbar fasciae. In second session 6 techniques were applied in order to improve quality and quantity of legs and pelvis mobility (all were external sof tissue techniques, without manipulation) : on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on pubic symphysis, on legs and pelvis and on lumbar fasciae
Sham Comparator: Sham protocol group; The sham group received a standardized protocol of ligth touch with wide pressure of the 2 hands, without intention to treat.	Other: Sham; Wide ligth touch pressure applied with the 2 hand at day 2-4 and day 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analogic Visual Scale of pain	Pain scale from 0 (no pain) to 10 (maximal pain).	at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSWESTRY	quality of life questionnary to evaluate fonctional incapacity. Score from 0 (no invalidity) to 50 (complete invalidity)	day 0 pre surgery - day 90 post surgery - day 105 post surgery
Hospital Anxiety and Depression	questionnary about depression and anxiety during hospitalisation. Score from 0 (no trouble) to 21 (severe trouble)	day 0 pre surgery, day 90 post surgery
Antalgic consumption	week table of antalgic consumption	from day 0 to day 105

Collaborators and Investigators

• Sponsor: Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
• Collaborators: Institut de la Colonne Vertébrale Lyon Charcot
• Investigators: Study Director: Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO, Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon; Study Chair: Pierre Grobost, PhD, Institut de la Colonne Vertébrale Lyon Charcot; Principal Investigator: Aline Rollet, Ostéopathe DO, MsC Cand., Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2024/0219L10/0219L17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: beginning 3 months and ending 3 years after publication of results
• IPD Sharing Access Criteria: on demand near to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No