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Recruiting NCT06802120

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

No phase Interventional Chirurgical Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: osteopathy real, sham osteopathy.
Who it may be relevant to
Registry conditions: Chirurgical Intervention. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other osteopathy real
    treatment with real osteopathy 2 times a week for 8 weeks
  • Other sham osteopathy
    treatment with sham osteopathy 2 times a week for 8 weeks

Primary outcome measures

  • Disability will be assessed using the ODQ [Time frame: baseline and Week 8]
Secondary outcome measures (2)
  • Pain and disability measures [Time frame: baseline, ans every week from 1 to 8]
  • The Osteopathic Dysfunction Palpation Assessment Scale [Time frame: baseline and Week 8]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

France · 1 center
  • Clinique Bizet — Paris

Identifiers

NCT: NCT06802120 · 2024-A01768-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗