ArthrodesisPhase 2NCT06669858
Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis
A Phase 2 study testing manual therapy in people with Arthrodesis and Post-operative Care, run by Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon at 1 site in France.
Trial summary
Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthrodesis, Post-operative Care, Manual Therapy
- What is being tested?
- manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2023to 1 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having surgery in Institut de la Colonne Vertébrale
- surgery of lumbosacral arthrodesis
Who cannot join
- spine deformation
- inflammatory rhumatim
- neurodegenerative pathology
- cognitive trouble
- neoplasic pathology
- surgery complication
- second surgery
- out of the study
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de la Colonne Vertébrale Lyon Charcot
Ste Foy Les Lyons, 69110
About this study
Official title: Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study
Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the quality of life of patients. Objectives : To study the effectiveness of osteopathy in the post-surgical management of lumbo-sacral arthrodesis. Methods : A pilot study including 35 patients who underwent lumbo-sacral arthrodesis divided into 2 groups: standardized osteopathic treatment and sham. The protocol consists of 2 post-operative sessions (D2 3 and D90). The evaluated criteria were pain intensity using the VAS, functional disability with the Oswestry questionnaire, anxiety and depression with the HAD questionnaire, and analgesic consumption. Result : Compared to the sham group, the osteopathic treatment group exhibited a lack of significance in the VAS (p= NS), Oswestry (p= NS) and HAD (p= NS) scores. Analgesic consumption also demonstrated a lack of statistical significance (p= NS). Discussion : In this study, osteopathy did not show an impact on HAD, Oswestry, VAS scores, or analgesic consumption. Based on other articles, there seems to be a link between the effectiveness of osteopathy and the frequency of sessions. Thus, it might be interesting to repeat the study with a larger sample size, the use of other measurement tools, and an increase in session frequency to validate these results.
- Conditions
- Arthrodesis, Post-operative Care, Manual Therapy, Lumbar Spine Surgery
- Being tested
- manual therapy, Sham
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapyOther
In first session 6 techniques were applied to favorise fluids circulation, respiratory mecanism end equilibration of pressions (all were external soft tissue techniques, without manipulation): on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on liver and spleen organ, on lumbar fasciae.
In second session 6 techniques were applied in order to improve quality and quantity of legs and pelvis mobility (all were external sof tissue techniques, without manipulation) : on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on pubic symphysis, on legs and pelvis and on lumbar fasciae
ShamOther
Wide ligth touch pressure applied with the 2 hand at day 2-4 and day 90
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy standardized protocol group | Experimental | This arm received 2 session of manual therapy (standardized protocol) 2-4 days after surgery and 90 days after surgery Receives: Other: manual therapy |
| Sham protocol group | Sham comparator | The sham group received a standardized protocol of ligth touch with wide pressure of the 2 hands, without intention to treat. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analogic Visual Scale of pain
Pain scale from 0 (no pain) to 10 (maximal pain).
Measured: at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery
Secondary outcomes (3)
OSWESTRY
quality of life questionnary to evaluate fonctional incapacity. Score from 0 (no invalidity) to 50 (complete invalidity)
Measured: day 0 pre surgery - day 90 post surgery - day 105 post surgery
Hospital Anxiety and Depression
questionnary about depression and anxiety during hospitalisation. Score from 0 (no trouble) to 21 (severe trouble)
Measured: day 0 pre surgery, day 90 post surgery
Antalgic consumption
week table of antalgic consumption
Measured: from day 0 to day 105
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Mar 2023
- Primary completion15 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de la Colonne Vertébrale Lyon Charcot
- Responsible party
- Sponsor
- Investigators
- Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO, Study director, Centre Européen d'Enseignement Supérieur de l'Ostéopathie de LyonPierre Grobost, PhD, Study chair, Institut de la Colonne Vertébrale Lyon CharcotAline Rollet, Ostéopathe DO, MsC Cand., Principal investigator, Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669858
- Sponsor's protocol ID
- 2024/0219L10/0219L17
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study
- ClinicalTrials.gov ID
- NCT06669858
- Acronym / sponsor ID
- 2024/0219L10/0219L17
- Conditions
- Arthrodesis, Post-operative Care, Manual Therapy, Lumbar Spine Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Européen d'Enseignement Supérieur de l'Ostéopathie de LyonUniversity, hospital or other
- Collaborators
- Institut de la Colonne Vertébrale Lyon Charcot
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 1 Nov 2024 (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.
Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the quality of life of patients. Objectives : To study the effectiveness of osteopathy in the post-surgical management of lumbo-sacral arthrodesis. Methods : A pilot study including 35 patients who underwent lumbo-sacral arthrodesis divided into 2 groups: standardized osteopathic treatment and sham. The protocol consists of 2 post-operative sessions (D2 3 and D90). The evaluated criteria were pain intensity using the VAS, functional disability with the Oswestry questionnaire, anxiety and depression with the HAD questionnaire, and analgesic consumption. Result : Compared to the sham group, the osteopathic treatment group exhibited a lack of significance in the VAS (p= NS), Oswestry (p= NS) and HAD (p= NS) scores. Analgesic consumption also demonstrated a lack of statistical significance (p= NS). Discussion : In this study, osteopathy did not show an impact on HAD, Oswestry, VAS scores, or analgesic consumption. Based on other articles, there seems to be a link between the effectiveness of osteopathy and the frequency of sessions. Thus, it might be interesting to repeat the study with a larger sample size, the use of other measurement tools, and an increase in session frequency to validate these results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy standardized protocol group | Experimental | Other: manual therapyThis arm received 2 session of manual therapy (standardized protocol) 2-4 days after surgery and 90 days after surgery |
| Sham protocol group | Sham comparator | Other: ShamThe sham group received a standardized protocol of ligth touch with wide pressure of the 2 hands, without intention to treat. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having surgery in Institut de la Colonne Vertébrale
- surgery of lumbosacral arthrodesis
Key exclusion criteria (8 listed)
- spine deformation
- inflammatory rhumatim
- neurodegenerative pathology
- cognitive trouble
- neoplasic pathology
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 |
|---|---|---|
| manual therapyIn first session 6 techniques were applied to favorise fluids circulation, respiratory mecanism end equilibration of pressions (all were external soft tissue techniques, without manipulation): on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on liver and spleen organ, on lumbar fasciae. In second session 6 techniques were applied in order to improve quality and quantity of legs and pelvis mobility (all were external sof tissue techniques, without manipulation) : on cervico dorsal hinge, on cranial diaphragm, on thoracic diaphragm, on pelvic diaphram, on pubic symphysis, on legs and pelvis and on lumbar fasciae | Other | Manual therapy standardized protocol group |
| ShamWide ligth touch pressure applied with the 2 hand at day 2-4 and day 90 | Other | Sham protocol group |
Primary outcome
Analogic Visual Scale of pain
Time frame: at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery
Pain scale from 0 (no pain) to 10 (maximal pain).
3 secondary outcomes
OSWESTRY
Time frame: day 0 pre surgery - day 90 post surgery - day 105 post surgery
Hospital Anxiety and Depression
Time frame: day 0 pre surgery, day 90 post surgery
Antalgic consumption
Time frame: from day 0 to day 105
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Arthrodesis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Active, not recruitingObservational study
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sacroiliitis, Sacroiliac Joint Dysfunction
Not yet recruiting
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
Single-level Lumbar Arthrodesis
Not yet recruitingEarly Phase 1
PliaFX Flo Subtalar Fusion Study
Subtalar Arthrodesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
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. This study is not recruiting at the moment.
Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO study director
Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
Pierre Grobost, PhD study chair
Institut de la Colonne Vertébrale Lyon Charcot
Aline Rollet, Ostéopathe DO, MsC Cand. principal investigator
Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing manual therapy in people with Arthrodesis and Post-operative Care, run by Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 1 Nov 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analogic Visual Scale of pain (time frame: at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery). 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 1 Nov 2024.