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

Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

Status and phase: Completed; Phase 2

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

Treatments: Other: Sham; Other: manual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06669858

2024/0219L10/0219L17

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Manual therapy standardized protocol group

Experimental group

Description:

This arm received 2 session of manual therapy (standardized protocol) 2-4 days after surgery and 90 days after surgery

Treatment:

Other: manual therapy

Sham protocol group

Sham Comparator group

Description:

The sham group received a standardized protocol of ligth touch with wide pressure of the 2 hands, without intention to treat.

Treatment:

Other: Sham