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

NCT ID: NCT06802120

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chirurgical Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Targeted osteopathic treatment

treatment with real osteopathy

Group Type EXPERIMENTAL

osteopathy real

Intervention Type OTHER

treatment with real osteopathy 2 times a week for 8 weeks

Non-targeted osteopathic treatment

treatment with sham osteopathy

Group Type PLACEBO_COMPARATOR

sham osteopathy

Intervention Type OTHER

treatment with sham osteopathy 2 times a week for 8 weeks

Interventions

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osteopathy real

treatment with real osteopathy 2 times a week for 8 weeks

Intervention Type OTHER

sham osteopathy

treatment with sham osteopathy 2 times a week for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut De La Colonne Vertebrale Et Des Neurosciences

OTHER

Sponsor Role collaborator

Ecole Supérieur d'Ostéopathie

OTHER

Sponsor Role collaborator

Clinique Bizet

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Bizet

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bouchra benkessou, PM

Role: CONTACT

0033140693525

Georges ABI LAHOUD, Professeur

Role: CONTACT

Facility Contacts

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bouchra Benkessou, PM

Role: primary

0764486016

Other Identifiers

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2024-A01768-39

Identifier Type: -

Identifier Source: org_study_id

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