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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combo Group | Active Comparator | Rehabilitation treatment combined with drug therapy |
|
| Reha Group | Active Comparator | Rehabilitation treatment |
|
| Drug Group | Active Comparator | Drug therapy with Pridinol Mesylate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation + Drug therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of pain: Numeric Rating Scale (NRS 0-10) | 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. | at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life: Short Form Health Survey 36 (0-100) | 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. | at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2) |
| Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giulia Letizia Mauro | A.O.U.P. Paolo Giaccone Palermo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone | Palermo | 90127 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28192789 | Background | Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14. | |
| 35575167 |
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| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
| Rehabilitation | 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 therapy | 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. |
|
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. |
| at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2) |
| Background |
| Uberall MA, Muller-Schwefe GHH, Horlemann J. Efficacy and tolerability of the antispasmodic, pridinol, in patients with muscle-pain - results of primepain, a retrospective analysis of open-label real-world data provided by the German pain E-registry. Curr Med Res Opin. 2022 Jul;38(7):1203-1217. doi: 10.1080/03007995.2022.2077579. Epub 2022 Jun 1. |
| 29971708 | Background | Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3. |
| D009140 |
| Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |