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

Not Applicable

Recruiting

• Conditions: Chirurgical Intervention

• Registration Number: NCT06802120
• Lead Sponsor: Clinique Bizet

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-02
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2027-03
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability will be assessed using the ODQ	baseline and Week 8	Oswestry Low Back Pain Disability Questionnaire

Secondary Outcome Measures

Name	Time	Method
Pain and disability measures	baseline, ans every week from 1 to 8	visual analogue scale of pain
The Osteopathic Dysfunction Palpation Assessment Scale	baseline and Week 8	Osteopathic Dysfunction Palpation Assessment Scale

Trial Locations

Locations (1)

Clinique Bizet; 🇫🇷 Paris, France