Hyaluronic Acid and Articular Pain (HApain)

February 5, 2025 updated by: Luca Gallelli, University of Catanzaro

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
20-items: score 20 to 49: no depression; 49-59 mild; 59-69 moderate; 70 - 80 severe anxiety
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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