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

NCT ID: NCT06669858

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

manual therapy

Intervention Type: OTHER

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 protocol group

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

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

Wide ligth touch pressure applied with the 2 hand at day 2-4 and day 90

Interventions

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

Intervention Type: OTHER

Sham

Wide ligth touch pressure applied with the 2 hand at day 2-4 and day 90

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de la Colonne Vertébrale Lyon Charcot

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO

Role: STUDY_DIRECTOR

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

Pierre Grobost, PhD

Role: STUDY_CHAIR

Institut de la Colonne Vertébrale Lyon Charcot

Aline Rollet, Ostéopathe DO, MsC Cand.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Institut de la Colonne Vertébrale Lyon Charcot

Ste Foy Les Lyons, , France

Countries

France

Other Identifiers

2024/0219L10/0219L17

Identifier Type: -

Identifier Source: org_study_id