Hyaluronic Acid and Articular Pain

NCT06814769 | Completed

• 1 other identifier: HA2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective longitudinal single-center clinical study on OA patients treated with HA . Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2; ), and 360 days (T3). The first efficacy end-point will be the statistically significant difference (P\<0.05) in VAS scale between T2 and T0 and between T3 and T2

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• pain change

  Numeric Pain Rating Scale: with a 0-10 points, where 0 is no pain and 10 is extreme pain

  12 months

• mood anxiety : zung scale

  20-items: score 0 - 44: no anxiety; 45 - 59 moderate anxiety; 60 - 80 severe anxiety

  12 months

Secondary Outcomes (1)

• mood depression: zung scale

  12 months

Study Arms (2)

cross link

cross link hyaluronic acid 1 intra-articular injection

Device: hyaluronic acid

linear

linear hyaluronic acid, 3 intra-articular injections

Device: hyaluronic acid

Interventions

hyaluronic acid DEVICE

intra-articular administration

cross link; linear

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data were collected directly by the medical staff involved in the study and Zung SAS, Zung SDS questionnaires were administered. The dedicated database evaluated and recorded any systemic or local side effects, in agreement with our previous studies (Gallelli et al., 2017, 2007; Marcianò et al., 2024). HA was administered in agreement with leaflet at the beginning of the study (T0) . Before the admission to this study, all the enrolled patients received systemic treatments with NSAIDs and/or local treatment with corticosteroids, without clinical benefit. Therefore, we considered the time before the administration as control group.

You may qualify if:

• Patients of both sexes between 18 and 65 years old, with a Body Mass Index \< 29 kg/m2.
• Patients with second- or third-degree of OA
• Patients with VAS (Visual Analogue Scale) intensities higher than 5/10 who did not respond to systemic medication therapy.
• Patients who can comprehend the study's objectives and (adhere to the orthopedist's instructions, return for follow-up, and complete the evaluation questionnaires).
• Patients able to provide their written informed consent to participate to the study and to use their data anonymously for scientific purposes

You may not qualify if:

• presence of active malignancy of any type or history of malignancy
• Local or systemic infection.
• Uncooperative patient or suffering from neurological disorders, therefore unable to follow the orthopedist's instructions or unable to provide informed consent for participation in the study or who have not provided written consent.

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

Luca Gallelli

Catanzaro, CZ, 88100, Italy

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 7, 2025
• Study Start: January 15, 2023
• Primary Completion: July 30, 2023
• Study Completion: December 20, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

IT (1)