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

Phase 2

Completed

• Conditions: Arthrodesis; Post-operative Care; Manual Therapy; Lumbar Spine Surgery

• Registration Number: NCT06669858
• Lead Sponsor: Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-02-15
• Study Completion: 2024-05-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut de la Colonne Vertébrale Lyon Charcot; 🇫🇷 Ste Foy Les Lyons, France