Chirurgical Intervention
Conditions
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.
Interventions
OTHERosteopathy real
treatment with real osteopathy 2 times a week for 8 weeks
OTHERsham osteopathy
treatment with sham osteopathy 2 times a week for 8 weeks
Sponsors
Institut De La Colonne Vertebrale Et Des Neurosciences
Ecole Supérieur d'Ostéopathie
Clinique Bizet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability will be assessed using the ODQ | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain and disability measures | 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 |
| The Osteopathic Dysfunction Palpation Assessment Scale | 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) |
Countries
France
Contacts
Primary ContactBouchra benkessou, PM
Backup ContactGeorges ABI LAHOUD, Professeur
Outcome results
None listed