Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis
ConditionChirurgical Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorClinique Bizet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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),
Trial design
Design model
Parallel
Treatments tested in this trial
osteopathy real
Other interventiontreatment with real osteopathy 2 times a week for 8 weeks
sham osteopathy
Other interventiontreatment with sham osteopathy 2 times a week for 8 weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Targeted osteopathic treatmentExperimental treatment 1 intervention
Group B: Non-targeted osteopathic treatmentPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline and Week 8Secondary outcomes
1
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
Time frame
baseline, ans every week from 1 to 82
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)
Time frame
baseline and Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Clinique Bizet
Lead sponsor
Institut De La Colonne Vertebrale Et Des Neurosciences
Collaborator
Ecole Supérieur d'Ostéopathie
Collaborator
Source ClinicalTrials.gov