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NCT Number: NCT06802120

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Bizet

Paris, 75116, France

Location status: Recruiting

Location contact

Georges ABI LAHOUD, Pr

PRINCIPAL_INVESTIGATOR

bouchra Benkessou, PM

CONTACT

[email protected]

0764486016

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

osteopathy real

Other

treatment with real osteopathy 2 times a week for 8 weeks

sham osteopathy

Other

treatment with sham osteopathy 2 times a week for 8 weeks

Primary outcomes

  1. Disability will be assessed using the ODQ

    Time frame: baseline and Week 8

    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.

Secondary outcomes

  1. Pain and disability measures

    Time frame: baseline, ans every week from 1 to 8

    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

  2. The Osteopathic Dysfunction Palpation Assessment Scale

    Time frame: baseline and Week 8

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Bouchra benkessou, PM

CONTACT

[email protected]

0033140693525

Georges ABI LAHOUD, Professeur

CONTACT

Sponsors and collaborators

Lead sponsor

Clinique Bizet

Other

Collaborators

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

Registry information

Official study title

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

Acronym: OSTEODESE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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