Hyaluronic Acid and Articular Pain (HApain)

Hyaluronic Acid in the Management of Articular Pain

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: hyaluronic acid

Detailed Description

This is a prospective longitudinal single-center clinical study on OA patients treated with HA at the Pain Medicine Room of the Clinical Pharmacology and Pharmacovigilance Operative Unit of the "Renato Dulbecco" University Hospital of Catanzaro from January 2023 to December 2024. Patients will be enrolled at baseline (T0) and then monitored at 90 days (T1), 180 days (T2), and 360 days (T3). At the beginning of the study, all enrolled patients signed the informed consent. After the enrollment (T0) and during the follow ups (T1-T3), clinical and laboratory data will be collected directly by the medical staff involved in the study and Zung SAS, Zung SDS and SF-36 questionnaires will be administered. The dedicated database evaluated and recorded any systemic or local side effects. HA will be administered at the beginning of the study (T0) in agreement with the leaflet.

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 the statistically significant difference (P<0.05) in functional mobility and walking ability (six minutes walking test) between T2 and T0 and between T3 and T2 the statistically significant difference (P<0.05) in mood disorders (Zung SAS and Zung SDS) between T2 and T0 and between T3 and T2

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Italy
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Luca Gallelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. presence of active malignancy of any type or history of malignancy
2. Local or systemic infection.
3. 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.
4. Any case not described in the inclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cross link; cross link hyaluronic acid 1 intra-articular injection	Device: hyaluronic acid; intra-articular administration
linear; linear hyaluronic acid, 3 intra-articular injections	Device: hyaluronic acid; intra-articular administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mood depression: zung scale	20-items: score 20 to 49: no depression; 49-59 mild; 59-69 moderate; 70 - 80 severe anxiety	12 months

Collaborators and Investigators

• Sponsor: University of Catanzaro

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Arthralgia; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: HA2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No