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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Spondyloarthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Combo Group

Rehabilitation treatment combined with drug therapy

Group Type ACTIVE_COMPARATOR

Rehabilitation + Drug therapy

Intervention Type OTHER

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.

Reha Group

Rehabilitation treatment

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type OTHER

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.

Drug Group

Drug therapy with Pridinol Mesylate

Group Type ACTIVE_COMPARATOR

Drug therapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No