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

Spondyloarthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06252064
• Other study ID #: MFR022024
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2024
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 15, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Spondylarthritis
• Spondylarthropathies
• Spondylitis
• Spondyloarthropathy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)	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)