Actively Recruiting
Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis A Parallel, Randomized and Double-Blind Controlled Pilot Study
Led by Clinique Bizet · Updated on 2026-01-06
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
C
Clinique Bizet
Lead Sponsor
I
Institut De La Colonne Vertebrale Et Des Neurosciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combined physiotherapy and osteopathy treatments compared to a placebo on disability and quality of life after lumbar arthrodesis surgery. This study aims to better understand the role of osteopathy as a non-drug approach in managing post-operative recovery. It focuses on analyzing two approaches: targeted osteopathy and non-targeted osteopathy, assessing their impact on patients' disability and quality of life following surgery. Participants will receive either real osteopathy or sham osteopathy treatments twice a week for eight weeks. The study is designed as a randomized, double-blind controlled pilot trial with two groups: one receiving targeted osteopathic treatment and the other receiving non-targeted, placebo-like osteopathic treatment. Treatment effects will be compared over the course of the eight-week intervention. During the study, disability will be measured using the Oswestry Disability Questionnaire (ODQ) at the start and at week 8. Pain and disability levels will be assessed weekly from baseline through week 8. The Osteopathic Dysfunction Palpation Assessment Scale will also be used at baseline and week 8 to evaluate osteopathic dysfunction. The study will monitor participants closely to assess treatment effects on disability and quality of life after lumbar arthrodesis surgery.
CONDITIONS
Brief Title
Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Lumbar arthrodesis surgery on one to three levels about four weeks before joining
- Stable pharmacological treatment for at least the last month
- Experiencing postoperative mechanical pain with a pain score of 4 or higher
You will not qualify if you...
- Neuropathic pain with a DN4 score of 4 or higher
- Diagnosis of fibromyalgia
- Presence of algodystrophy
- Other somatic or neuropsychiatric diseases except depression and anxiety
- Received osteopathic treatment within the last three months
- Currently participating in another interventional research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive either real or sham osteopathic treatment twice a week.
2 visits per week for 8 weeks
Trial Site Locations
Total: 1 location
1
Clinique Bizet
Paris, France, 75116
Actively Recruiting
Research Team
B
Bouchra benkessou, PM
G
Georges ABI LAHOUD, Professeur
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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