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NCT Number: NCT06669858

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut de la Colonne Vertébrale Lyon Charcot

Ste Foy Les Lyons, 69110, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual therapy

Other

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

SHAM

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. OSWESTRY

    Time frame: day 0 pre surgery - day 90 post surgery - day 105 post surgery

    quality of life questionnary to evaluate fonctional incapacity. Score from 0 (no invalidity) to 50 (complete invalidity)

  2. Hospital Anxiety and Depression

    Time frame: day 0 pre surgery, day 90 post surgery

    questionnary about depression and anxiety during hospitalisation. Score from 0 (no trouble) to 21 (severe trouble)

  3. Antalgic consumption

    Time frame: from day 0 to day 105

    week table of antalgic consumption

Sponsors and collaborators

Lead sponsor

Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon

Other

Collaborators

  • Institut de la Colonne Vertébrale Lyon Charcot

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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