Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain

University of Palermo

Status: Completed

Conditions: Spondyloarthropathy

Treatments: Other: Rehabilitation + Drug therapy; Other: Rehabilitation; Other: Drug therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06252064

MFR022024

Details and patient eligibility

About

Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.It can be conservative, pharmacological and interventional, rarely chirurgic. This study aimed to evaluate the effectiveness of a rehabilitation program combined with Pridinol Mesylate in the treatment of Spondyloarthrosis in elderly patients in terms of pain resolution, improving disability, and quality of life versus single treatment.

A randomized controlled trial was conducted in patients with spondyloarthritis. The patients recruited were divided into three groups: the Combined Group (CG), who received a rehabilitation program combined with Pridinol Mesylate; the Rehabilitation Group (RG), who received only the same rehabilitation program; and the Drug Group (DG), who received only the administration of the drug.

Enrollment: 86 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 65-75 years,
• low back pain for at least 3 months,
• NRS ≥ 4,
• radiographic diagnosis of spondyloarthrosis,
• written informed consent.

Exclusion criteria

• inflammatory diseases of the spine,
• obesity (BMI 20-30),
• positive radicular tests,
• allergy or contraindications related to taking Pridinol Mesylate.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 3 patient groups

Combo Group

Active Comparator group

Description:

Rehabilitation treatment combined with drug therapy

Treatment:

Other: Rehabilitation + Drug therapy

Reha Group

Active Comparator group

Description:

Rehabilitation treatment

Treatment:

Other: Rehabilitation

Drug Group

Active Comparator group

Description:

Drug therapy with Pridinol Mesylate

Treatment:

Other: Drug therapy