Osteoarthritis Thumb Clinical Trial
Official title:
Comparison of the Efficacy of Intra-articular Hybrid Hyaluronic Acid and Steroid in Patients With Rizoarthrosis
Verified date | June 2017 |
Source | University of Siena |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Osteoarthritis of the trapeziometacarpal joint (TMJ), also called rhizarthrosis is a common
disease, mostly affecting post-menopausal women. Intra-articular therapy with hyaluronic
acid (HA) was usually recommended as a second-line treatment after failure of
non-pharmacological modalities, only in early stages of the disease .Aim of the present
observational, retrospective, comparative study is the assessment of the efficacy and
tolerability of i.a. injections of an hybrid HA formulation (Synovial H-L®) in comparison to
triamcinolone in patients with TMJ Osteoarthritis (OA). We are analyzing the records
collected in the departmental archives of outpatients affected by TMJ OA, according to the
ACR criteria for the classification for hand OA and who were treated with i.a. Sinovial H-L
or triamcinolone acetonide from December 1st, 2015 to December 1st 2016.The patient's
assessment of spontaneous hand pain on a 0-100 mm VAS with 0 representing the absence of
pain and the FIHOA score validated in Italian language were routinely recorded and
documented in our centre prior to the injections (T0), at the time of the second i.a.
administration (T1), after one month (T2) and after 3 (T3) and 6 months (T4) following the
i.a. therapy.
The primary outcome criteria of our study is the change of VAS and FIHOA from baseline to
the end of treatment. Furthermore, we chose as secondary outcomes the duration of morning
stiffness, the Italian version of Health Assessment Questionnaire (HAQ) and the validated
Italian version of the Medical Outcomes Study 36-Item Short Form (SF-36) routinary
registered in our medical record before the i.a. therapy, at the end of the treatment and
after 1, 3 and 6 months.
The chi square test, t test or Kruskal-Wallis test, as appropriated, will be used to
evaluate differences between groups before i.a. treatment the clinical and demographical
data.
Mixed-effects linear regression models will be used to evaluate temporal trends and
differences in the two groups for specific outcomes: VAS pain, VAS stiffness, FIHOA and PCS
and MCS from SF-36 questionnaires. In these types of statistical models, the effects of the
covariates and their standard errors are correctly estimated taking into account the
hierarchical structure of the data (i.e., patients and visits). For the compute of SF-36s Z
score will be used mean and SD of U.S. general population. Data analysis will be performed
using Stata vers 13.0 software. Descriptive statistics will be used to summarize data as
frequencies (categorical variables) or mean +/-SD (continuous variables) as appropriate. P
values <0.05 is considered statistically significant.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2017 |
Est. primary completion date | May 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - clinical symptoms in the treated thumb for at least 3 months prior to the beginning of i.a. treatment with at least 30 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand OA (FIHOA) score of at least 6 - radiographic evidence of TMJ OA within the previous 6 months with a radiological score of II-III (using the Kellgren method) Exclusion Criteria: - any inflammatory joint disease - septic arthritis - major trauma - prior surgery of the hand, wrist, and elbow - coagulation disorders - severe comorbidity - past therapy with chondroitin sulfate, glucosamine, diacerein, steroids by any route of administration - i.a. injection of any joint with corticosteroids or HA during the previous 6 months |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Senese | Siena |
Lead Sponsor | Collaborator |
---|---|
University of Siena |
Italy,
Fioravanti A, Cantarini L, Chellini F, Manca D, Paccagnini E, Marcolongo R, Collodel G. Effect of hyaluronic acid (MW 500-730 kDa) on proteoglycan and nitric oxide production in human osteoarthritic chondrocyte cultures exposed to hydrostatic pressure. Os — View Citation
Henrotin Y, Raman R, Richette P, Bard H, Jerosch J, Conrozier T, Chevalier X, Migliore A. Consensus statement on viscosupplementation with hyaluronic acid for the management of osteoarthritis. Semin Arthritis Rheum. 2015 Oct;45(2):140-9. doi: 10.1016/j.se — View Citation
Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies — View Citation
Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dinçer F, Dziedzic K, Häuselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martín-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Górska — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of VAS | 0-100 mm VAS with 0 representing the absence of pain. | basal time; 2 weeks; 1 month; 3 months; 6 months | |
Primary | Change of FIHOA | FIHOA validated in Italian language | basal time; 2 weeks; 1 month; 3 months; 6 months | |
Secondary | Change of duration of morning stiffness | measured in minutes | basal time; 2 weeks;1 month; 3 months; 6 months | |
Secondary | Change of Health Assessment Questionnaire (HAQ) | Italian version of HAQ | basal time; 2 weeks; 1 month; 3 months; 6 months | |
Secondary | Change of the Medical Outcomes Study 36-Item Short Form (SF-36) | validated Italian version of SF-36 | basal time; 2 weeks; 1 month; 3 months; 6 months |
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