Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis

NCT06802120 | Recruiting DMC

• 1 other identifier: 2024-A01768-39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and Week 8

Secondary Outcomes (2)

• Pain and disability measures

  baseline, ans every week from 1 to 8

• The Osteopathic Dysfunction Palpation Assessment Scale

  baseline and Week 8

Study Arms (2)

Targeted osteopathic treatment

EXPERIMENTAL

treatment with real osteopathy

Other: osteopathy real

Non-targeted osteopathic treatment

PLACEBO COMPARATOR

treatment with sham osteopathy

Other: sham osteopathy

Interventions

osteopathy real OTHER

treatment with real osteopathy 2 times a week for 8 weeks

Targeted osteopathic treatment

sham osteopathy OTHER

treatment with sham osteopathy 2 times a week for 8 weeks

Non-targeted osteopathic treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being under a stable pharmacological treatment over the last month
• who are suffering from postoperative mechanical pain (VAS ≥ 4)

You may not qualify if:

• 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),
• are included in another interventional research protocol during the study period

Sponsors & Collaborators

• Clinique Bizet: lead
• Ecole Supérieur d'Ostéopathie: collaborator
• Institut De La Colonne Vertebrale Et Des Neurosciences: collaborator

Study Sites (1)

Clinique Bizet

Paris, 75116, France

RECRUITING

Central Study Contacts

Bouchra benkessou, PM

CONTACT

0033140693525; b.benkessou@hexagone-sante-paris.fr

Georges ABI LAHOUD, Professeur

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

FR (1)