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

Not Applicable

Completed

• Conditions: Spondyloarthropathy
• Interventions: Other: Rehabilitation; Other: Drug therapy; Other: Rehabilitation + Drug therapy

• Registration Number: NCT06252064
• Lead Sponsor: University of Palermo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-01-15
• Study First Submitted: 2024-01-22
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reha Group	Rehabilitation	Rehabilitation treatment
Drug Group	Drug therapy	Drug therapy with Pridinol Mesylate
Combo Group	Rehabilitation + Drug therapy	Rehabilitation treatment combined with drug therapy

Primary Outcome Measures

Name	Time	Method
Extent of pain: Numeric Rating Scale (NRS 0-10)	at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)	The NRS is a subjective scale that rates the extent of pain with a score between 0 and 10; a score of 10 corresponds to maximum pain.

Secondary Outcome Measures

Name	Time	Method
Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)	at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)	is a condition-specific questionnaire developed to measure the level of functional disability for patients with low back pain. These outcomes score within the range of 0 and 100, determents the level of functional disability, with higher numbers representing greater levels of disability.
Quality of life: Short Form Health Survey 36 (0-100)	at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)	SF-36 is a scale that assesses the quality of life in relation to the disease from which patients suffer. A score of 100 corresponds to an optimal value.

Trial Locations

Locations (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone; 🇮🇹 Palermo, Italy