Spondyloarthropathy
Conditions
Keywords
Spondylarthropathies, Pridinol Mesilate, Low Back Pain, Rehabilitation, Therapy
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.
Interventions
OTHERRehabilitation + 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.
OTHERRehabilitation
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.
OTHERDrug 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
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Italy
Outcome results
None listed