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Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis

Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06669858
Enrollment
35
Registered
2024-11-01
Start date
2023-03-01
Completion date
2024-05-01
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrodesis, Lumbar Spine Surgery, Manual Therapy, Post-operative Care

Brief 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 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.

Interventions

OTHERmanual therapy

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

OTHERSham

Wide ligth touch pressure applied with the 2 hand at day 2-4 and day 90

Sponsors

Institut de la Colonne Vertébrale Lyon Charcot
CollaboratorUNKNOWN
Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* having surgery in Institut de la Colonne Vertébrale * surgery of lumbosacral arthrodesis

Exclusion criteria

* spine deformation * inflammatory rhumatim * neurodegenerative pathology * cognitive trouble * neoplasic pathology * surgery complication * second surgery * out of the study

Design outcomes

Primary

MeasureTime frameDescription
Analogic Visual Scale of painat day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgeryPain scale from 0 (no pain) to 10 (maximal pain).

Secondary

MeasureTime frameDescription
OSWESTRYday 0 pre surgery - day 90 post surgery - day 105 post surgeryquality of life questionnary to evaluate fonctional incapacity. Score from 0 (no invalidity) to 50 (complete invalidity)
Hospital Anxiety and Depressionday 0 pre surgery, day 90 post surgeryquestionnary about depression and anxiety during hospitalisation. Score from 0 (no trouble) to 21 (severe trouble)
Antalgic consumptionfrom day 0 to day 105week table of antalgic consumption

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026