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

NCT06252064 | Completed DMC

• 1 other identifier: MFR022024
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthropathy

Keywords

Spondylarthropathies; Pridinol Mesilate; Low Back Pain; Rehabilitation; Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (3)

Combo Group

ACTIVE COMPARATOR

Rehabilitation treatment combined with drug therapy

Other: Rehabilitation + Drug therapy

Reha Group

ACTIVE COMPARATOR

Rehabilitation treatment

Other: Rehabilitation

Drug Group

ACTIVE COMPARATOR

Drug therapy with Pridinol Mesylate

Other: Drug therapy

Interventions

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.

Combo Group

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.

Reha Group

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.

Drug Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age 65-75 years,
• low back pain for at least 3 months,
• NRS ≥ 4,
• radiographic diagnosis of spondyloarthrosis,
• written informed consent.

You may not qualify if:

• inflammatory diseases of the spine,
• obesity (BMI 20-30),
• positive radicular tests,
• allergy or contraindications related to taking Pridinol Mesylate.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Palermo, 90127, Italy

Location

Related Publications (3)

• 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.

  PMID: 28192789 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.

  PMID: 35575167 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.

  PMID: 29971708 BACKGROUND

MeSH Terms

Conditions

Spondylarthropathies; Low Back Pain

Interventions

Rehabilitation; Drug Therapy

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Giulia Letizia Mauro

  A.O.U.P. Paolo Giaccone Palermo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 9, 2024
• Study Start: March 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: January 15, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)