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

Clinique Bizet

Status: Enrolling

Conditions: Chirurgical Intervention

Treatments: Other: sham osteopathy; Other: osteopathy real

Study type: Interventional

Funder types: Other

Identifiers

NCT06802120

2024-A01768-39

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion
• being under a stable pharmacological treatment over the last month
• who are suffering from postoperative mechanical pain (VAS ≥ 4)

Exclusion criteria

• 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),
• have received osteopathic treatment over the last three month prior to inclusion,
• are included in another interventional research protocol during the study period

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Targeted osteopathic treatment

Experimental group

Description:

treatment with real osteopathy

Treatment:

Other: osteopathy real

Non-targeted osteopathic treatment

Placebo Comparator group

Description:

treatment with sham osteopathy

Treatment:

Other: sham osteopathy