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Completed

NCT Number: NCT06252064

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

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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Key information

Conditions

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

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Extent of pain: Numeric Rating Scale (NRS 0-10)

    Time frame: 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 outcomes

  1. Quality of life: Short Form Health Survey 36 (0-100)

    Time frame: 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.

  2. Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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