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

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: Chirurgical Intervention
• Intervention / Treatment: Other: osteopathy real; Other: sham osteopathy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bouchra BENKESSOU, PM; Phone Number: 0033140693525; Email: b.benkessou@hexagone-sante-paris.fr
• Study Contact Backup: Name: georges ABI LAHOUD, Professeur

Study Locations

• France
  • Paris, France, 75116
    • Recruiting
    • Clinique Bizet
    • Contact: Bouchra BENKESSOU, PM; Phone Number: 0764486016; Email: b.benkessou@hexagone-sante-paris.fr
    • Principal Investigator: Georges ABI LAHOUD, Pr

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Oswestry Low Back Pain Disability Questionnaire; Minimum Value: 0; Maximum Value: 100; Interpretation: Higher scores indicate a worse outcome => greater disability due to low back pain.	baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and disability measures	The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience. Minimum and maximum values: 0 = complete absence of the symptom 10 = the most severe imaginable intensity of the symptom Score interpretation: Higher scores indicate greater symptom intensity Lower scores indicate lesser intensity	baseline, ans every week from 1 to 8
The Osteopathic Dysfunction Palpation Assessment Scale	Osteopathic Dysfunction Palpation Assessment Scale Minimum value: 0 (no dysfunction detected) Maximum value: Each anatomical structure (e.g., ilium, pubis, sacrum, spine, etc.) is assessed on 4 criteria: mobility, viscoelasticity, texture, temperature. For each criterion, the score is 0 or 1 (absence or presence of dysfunction). For each structure, the maximum score is therefore 4. The total maximum score depends on the number of structures assessed Interpretation: The higher the score, the greater the osteopathic dysfunction (so a higher score indicates a worse outcome)	baseline and Week 8

Collaborators and Investigators

• Sponsor: Clinique Bizet
• Collaborators: Ecole Supérieur d'Ostéopathie; Institut De La Colonne Vertebrale Et Des Neurosciences

Study record dates

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 (Actual): January 31, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

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