Clinical trial NCT06252064: Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain
Official title: Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthropathy
Keywords: Spondylarthropathies
Pridinol Mesilate
Low Back Pain
Rehabilitation
Therapy
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Extent of pain: Numeric Rating Scale (NRS 0-10)
timeFrame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Secondary outcomes:
measure: Quality of life: Short Form Health Survey 36 (0-100)
timeFrame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
measure: Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)
timeFrame: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Study officials:
affiliation: A.O.U.P. Paolo Giaccone Palermo
name: Giulia Letizia Mauro
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.