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

NCT06669858 | Completed Phase 2

• 1 other identifier: 2024/0219L10/0219L17
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• OSWESTRY

  day 0 pre surgery - day 90 post surgery - day 105 post surgery

• Hospital Anxiety and Depression

  day 0 pre surgery, day 90 post surgery

• Antalgic consumption

  from day 0 to day 105

Study Arms (2)

Manual therapy standardized protocol group

EXPERIMENTAL

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

Other: manual therapy

Sham protocol group

SHAM COMPARATOR

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

Other: Sham

Interventions

manual therapy 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

Manual therapy standardized protocol group

Sham OTHER

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

Sham protocol group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon: lead
• Institut de la Colonne Vertébrale Lyon Charcot: collaborator

Study Sites (1)

Institut de la Colonne Vertébrale Lyon Charcot

Ste Foy Les Lyons, 69110, France

Location

MeSH Terms

Conditions

Ankylosis

Interventions

Musculoskeletal Manipulations; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO

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

  STUDY DIRECTOR

• Pierre Grobost, PhD

  Institut de la Colonne Vertébrale Lyon Charcot

  STUDY CHAIR

• Aline Rollet, Ostéopathe DO, MsC Cand.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: March 1, 2023
• Primary Completion: February 15, 2024
• Study Completion: May 1, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 3 months and ending 3 years after publication of results
• Access Criteria: on demand near to the principal investigator

Locations

FR (1)