Dataset Information

Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study.

ABSTRACT:

Background

Pronolis®HD mono 2.5% is a novel, one-shot, high-density sterile viscoelastic solution, recently available in Spain, which contains a high amount of intermediate molecular weight hyaluronic acid (HA), highly concentrated (120 mg in 4.8 mL solution: 2.5%). The objective of the study was to analyze the efficacy and safety of this treatment in symptomatic primary knee osteoarthritis (OA).

Methods

This observational, prospective, multicenter, single-cohort study involved 166 patients with knee OA treated with a single-shot of Pronolis®HD mono 2.5% and followed up as many as 24 weeks.

Results

Compared with baseline, the score of the Western Ontario and McMaster Universities Arthritis Osteoarthritis Index (WOMAC) pain subscale reduced at the 12-week visit (primary endpoint, median: 9 interquartile range [IQR]: 7-11 versus median: 4; IQR: 2-6; p < 0.001). The percentage of patients achieving > 50% improvement in the pain subscale increased progressively from 37.9% (at 2 weeks) to 66.0% (at 24 weeks). Similarly, WOMAC scores for pain on walking, stiffness subscale, and functional capacity subscale showed significant reductions at the 12-week visit which were maintained up to the 24-week visit. The EuroQol visual analog scale score increased after 12 weeks (median: 60 versus 70). The need for rescue medication (analgesics/nonsteroidal anti-inflammatory drugs) also decreased in all post-injection visits. Three patients (1.6%) reported local adverse events (joint swelling) of mild intensity.

Conclusions

In conclusion, a single intra-articular injection of the high-density viscoelastic gel of HA was associated with pain reduction and relief of other symptoms in patients with knee OA.

Trial registration

ClinicalTrial# NCT04196764.

SUBMITTER: Calvet J

PROVIDER: S-EPMC9097347 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study.

Calvet Joan J Khorsandi Danial D Tío Laura L Monfort Jordi J

BMC musculoskeletal disorders 20220511 1

<h4>Background</h4>Pronolis®HD mono 2.5% is a novel, one-shot, high-density sterile viscoelastic solution, recently available in Spain, which contains a high amount of intermediate molecular weight hyaluronic acid (HA), highly concentrated (120 mg in 4.8 mL solution: 2.5%). The objective of the study was to analyze the efficacy and safety of this treatment in symptomatic primary knee osteoarthritis (OA).<h4>Methods</h4>This observational, prospective, multicenter, single-cohort study involved 16 ...[more]

PMID: 35546401

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Project description:BackgroundExperimental and clinical evidence support a link between body representations and pain. This proof-of-concept study in people with painful knee osteoarthritis (OA) aimed to determine if: (i) visuotactile illusions that manipulate perceived knee size are analgesic; (ii) cumulative analgesic effects occur with sustained or repeated illusions.MethodsParticipants with knee OA underwent eight conditions (order randomised): stretch and shrink visuotactile (congruent) illusions and corresponding visual, tactile and incongruent control conditions. Knee pain intensity (0-100 numerical rating scale; 0 = no pain at all and 100 = worst pain imaginable) was assessed pre- and post-condition. Condition (visuotactile illusion vs control) × Time (pre-/post-condition) repeated measure ANOVAs evaluated the effect on pain. In each participant, the most beneficial illusion was sustained for 3 min and was repeated 10 times (each during two sessions); paired t-tests compared pain at time 0 and 180s (sustained) and between illusion 1 and illusion 10 (repeated).ResultsVisuotactile illusions decreased pain by an average of 7.8 points (95% CI [2.0-13.5]) which corresponds to a 25% reduction in pain, but the tactile only and visual only control conditions did not (Condition × Time interaction: p = 0.028). Visuotactile illusions did not differ from incongruent control conditions where the same visual manipulation occurred, but did differ when only the same tactile input was applied. Sustained illusions prolonged analgesia, but did not increase it. Repeated illusions increased the analgesic effect with an average pain decrease of 20 points (95% CI [6.9-33.1])-corresponding to a 40% pain reduction.DiscussionVisuotactile illusions are analgesic in people with knee OA. Our results suggest that visual input plays a critical role in pain relief, but that analgesia requires multisensory input. That visual and tactile input is needed for analgesia, supports multisensory modulation processes as a possible explanatory mechanism. Further research exploring the neural underpinnings of these visuotactile illusions is needed. For potential clinical applications, future research using a greater dosage in larger samples is warranted.

Project description:Genicular artery embolization (GAE) is a novel therapy to treat patients with symptomatic knee osteoarthritis (OA) by reducing synovial arterial hypervascularity. This study evaluates the safety and efficacy of GAE for the treatment of symptomatic knee OA. A prospective, single-center, open-label U.S. Food and Drug Administration-approved investigational device exemption study was conducted. Patients enrolled in the study were 40 to 80 years old, with moderate or severe knee OA (Kellgren-Lawrence grade 2, 3, or 4), who previously had failure of conservative therapy. Baseline pain (visual analog scale [VAS]) and symptom scores (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) were assessed. After femoral arterial access was achieved, GAE of 1, 2, or 3 genicular arteries supplying the location of the subject's pain, as determined by digital subtraction angiography and cone-beam computed tomography, was performed using 100-μm particles. Adverse events and symptoms scores were assessed at 1 week, 1 month, 3 months, 6 months, and 1 year after GAE. Over a 10-month period, 40 subjects were enrolled. The median age was 69 years (range, 49 to 80 years). The median body mass index was 29 kg/m2 (range, 19 to 44 kg/m2). Knee OA severity was grade 2 in 18% of the patients, grade 3 in 43%, and grade 4 in 40%. Technical success was achieved in 100% of the subjects. Transient skin discoloration and transient mild knee pain after the procedure were common and expected. Treatment-related adverse events included a groin hematoma requiring overnight observation in 1 subject, self-resolving focal skin ulceration in 7 subjects, and an asymptomatic small bone infarct on magnetic resonance imaging at 3 months in 2 subjects. The WOMAC total and VAS pain scores decreased by 61% and 67% at 12 months from a median baseline of 52 (of 96) and 8 (of 10), respectively. Twenty-seven patients (68%) had a reduction of ≥50% in both WOMAC total and VAS pain scores. This prospective trial demonstrates that GAE is effective and durable in reducing pain symptoms from moderate or severe knee OA that is refractory to other conservative therapy, with an acceptable safety profile. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study.

Background

Methods

Results

Conclusions

Trial registration

Publications

Evaluation of a single-shot of a high-density viscoelastic solution of hyaluronic acid in patients with symptomatic primary knee osteoarthritis: the no-dolor study.

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