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

NCT06252064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-02-09

No results posted yet for this study

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.

Conditions

  • Spondyloarthropathy

Interventions

OTHER

Rehabilitation + Drug therapy

Patients in the Combo group underwent rehabilitation treatment combined with drug therapy: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. Patients included in this group also took drug therapy, particularly Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days.

OTHER

Rehabilitation

Patients in the Reha group underwent rehabilitation treatment: the rehabilitation protocol included daily sessions, 5 days a week, lasting 60 minutes, for a total of 4 consecutive weeks. The treatment included an initial step, lasting 40 minutes, of Postural Reeducation ending with Stretching exercises of the posterior kinetic chain muscles lasting 20 minutes.

OTHER

Drug therapy

The Drug Group had taken Pridinol Mesylate orally, on an empty stomach, 2 mg x 3 times a day for 20 days. The tablet was taken without chewing and with a glass of water (200 ml). The drug was taken in environments with temperature below 25° C.

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Giulia Letizia Mauro · A.O.U.P. Paolo Giaccone Palermo

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-06-30
Completion
2024-01-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06252064 on ClinicalTrials.gov