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

NCT06669858 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

manual 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

OTHER

Sham

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

Sponsors & Collaborators

  • Institut de la Colonne Vertébrale Lyon Charcot

    collaborator UNKNOWN
  • Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

    lead OTHER

Principal Investigators

  • Laurianne Tournier-Pinloche, PhD, MsC, Osteopathe DO · Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

  • Pierre Grobost, PhD · Institut de la Colonne Vertébrale Lyon Charcot

  • Aline Rollet, Ostéopathe DO, MsC Cand. · Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-02-15
Completion
2024-05-01

Countries

  • France

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Read the full study record

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View NCT06669858 on ClinicalTrials.gov