Chirurgical InterventionOSTEODESENCT06802120
Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis
A study testing osteopathy real in people with Chirurgical Intervention, run by Clinique Bizet at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chirurgical Intervention
- What is being tested?
- osteopathy real
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Georges ABI LAHOUD, Professeur contact
France1 site, 1 recruiting
- Recruiting
Clinique Bizet
Paris, 75116
bouchra Benkessou, PM, 0764486016, b.benkessou@hexagone-sante-paris.fr
Georges ABI LAHOUD, Pr
About this study
Official title: Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis. A PARALLEL, RANDOMIZED AND DOUBLE-BLIND CONTROLLED PILOT STUDY
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.
- Conditions
- Chirurgical Intervention
- Being tested
- osteopathy real, sham osteopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathy realOther
treatment with real osteopathy 2 times a week for 8 weeks
sham osteopathyOther
treatment with sham osteopathy 2 times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Targeted osteopathic treatment | Experimental | treatment with real osteopathy Receives: Other: osteopathy real |
| Non-targeted osteopathic treatment | Placebo comparator | treatment with sham osteopathy Receives: Other: sham osteopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and Week 8
Secondary outcomes (2)
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
Measured: baseline, ans every week from 1 to 8
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)
Measured: baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start2 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chirurgical InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Collaborators
- Institut De La Colonne Vertebrale Et Des Neurosciences, Ecole Supérieur d'Ostéopathie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802120
- Sponsor's protocol ID
- 2024-A01768-39
- Acronym
- OSTEODESE
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis. A PARALLEL, RANDOMIZED AND DOUBLE-BLIND CONTROLLED PILOT STUDY
- ClinicalTrials.gov ID
- NCT06802120
- Acronym / sponsor ID
- OSTEODESE / 2024-A01768-39
- Conditions
- Chirurgical Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Collaborators
- Institut De La Colonne Vertebrale Et Des Neurosciences, Ecole Supérieur d'Ostéopathie
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted osteopathic treatment | Experimental | Other: osteopathy realtreatment with real osteopathy |
| Non-targeted osteopathic treatment | Placebo comparator | Other: sham osteopathytreatment with sham osteopathy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osteopathy realtreatment with real osteopathy 2 times a week for 8 weeks | Other | Targeted osteopathic treatment |
| sham osteopathytreatment with sham osteopathy 2 times a week for 8 weeks | Other | Non-targeted osteopathic treatment |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chirurgical Intervention
RecruitingPhase 2
Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.
Chirurgical Intervention, Thrombocytopaenia
Recruiting
Evaluation of the Effect of Reiki on Pain After Spinal Fusion
Chirurgical Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georges ABI LAHOUD, Professeur contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathy real in people with Chirurgical Intervention, run by Clinique Bizet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bouchra benkessou, PM (0033140693525, b.benkessou@hexagone-sante-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability will be assessed using the ODQ (time frame: baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.