Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis (OSTEODESE)

January 27, 2025 updated by: Clinique Bizet

Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis. A PARALLEL, RANDOMIZED AND DOUBLE-BLIND CONTROLLED PILOT STUDY

The aim of our study is to assess the effect of a combined physiotherapy and osteopathy treatment versus a placebo on the management of disability and quality of life after lumbar arthrodesis. This study will provide a better assessment of the use of osteopathy as a non pharmacological approach to post-operative management.

For this purpose, We will analyze the effects of these two approaches, targeted and non-targeted osteopathy (TO vs. NTO), on patients' disability and quality of life after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Georges ABI LAHOUD, Professeur

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion
  • being under a stable pharmacological treatment over the last month
  • who are suffering from postoperative mechanical pain (VAS ≥ 4)

Exclusion Criteria:

  • neuropathic pain according to a DN4 score greater than or equal to 4/10,
  • are suffering from fibromyalgia,
  • algodystrophy,
  • other somatic or neuropsychiatric diseases (other than depression and anxiety),
  • have received osteopathic treatment over the last three month prior to inclusion,
  • are included in another interventional research protocol during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Targeted osteopathic treatment
treatment with real osteopathy
Other: osteopathy real
treatment with real osteopathy 2 times a week for 8 weeks
Placebo Comparator: Non-targeted osteopathic treatment
treatment with sham osteopathy
Other: sham osteopathy
treatment with sham osteopathy 2 times a week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability will be assessed using the ODQ
Time Frame: baseline and Week 8
Oswestry Low Back Pain Disability Questionnaire
baseline and Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and disability measures
Time Frame: baseline, ans every week from 1 to 8
visual analogue scale of pain
baseline, ans every week from 1 to 8
The Osteopathic Dysfunction Palpation Assessment Scale
Time Frame: baseline and Week 8
Osteopathic Dysfunction Palpation Assessment Scale
baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Bizet

Collaborators

Ecole Supérieur d'Ostéopathie
Institut De La Colonne Vertebrale Et Des Neurosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Estimated)

January 31, 2025

Study Record Updates

Last Update Posted (Estimated)

January 31, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-A01768-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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