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No significant short-term difference on pain & function between photo-activated PRP and HA
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OSTEOARTHRITIS
No significant short-term difference on pain & function between photo-activated PRP and HA .

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2016;4(21):11 BMC Musculoskelet Disord. 2016 Feb 9;17(1):67
Autores contribuintes

KL Paterson M Nicholls KL Bennell D Bates

23 patients with mild-moderate knee osteoarthritis were randomized to three weekly intra-articular injections of either hyaluronic acid (HA; Synvisc Hylan G-F 20) or photo-activated platelet-rich plasma (PRP). The purpose of this study was to compare pain and functional outcome between the two groups at 4 and 12 week follow-up after the last injection. Efficacy outcomes included a visual analog scale (VAS) for pain, the Knee Injury and Osteoarthritis Outcome Scale (KOOS), the Knee Quality of Life 26-Item questionnaire (KQoL-26), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and functional performance tests. Findings demonstrated no significant differences between groups at either 4 or 12 week follow-up for any outcome measures. Nonetheless, as this was a pilot study, the trial was underpowered to accurately assess comparative efficacy between treatment options.


Detalhes do financiamento da publicação +
Financiamento:
Industry funded
Patrocinador:
AdiStem Ltd; Australian Research Council Future Fellowship
Conflicts:
None disclosed

Risco de viés

8/10

Critérios de notificação

16/20

Índice de Fragilidade

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Sim = 1

Incerto = 0,5

Não relevante = 0

Não = 0

A Avaliação dos Critérios de Relato avalia a transparência com que os autores relatam as caraterísticas metodológicas e do ensaio na publicação. A avaliação está dividida em cinco categorias que são apresentadas de seguida.

2/4

Randomization

3/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

3/4

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

O Índice de Fragilidade é uma ferramenta que auxilia na interpretação de achados significativos, fornecendo uma medida de força para um resultado. O Índice de Fragilidade representa o número de eventos consecutivos que precisam de ser adicionados a um resultado dicotómico para que o resultado deixe de ser significativo. Um número pequeno representa um resultado mais fraco e um número grande representa um resultado mais forte.

Porque é que este estudo era necessário agora?

Injection therapies have been increasingly prominent within research regarding treatment of knee osteoarthritis, with numerous randomized controlled trials investigating the efficacy of various products. Of these, popular topics include viscosupplementation with hyaluronic acid, and platelet rich plasma. Specifically regarding PRP, the use of photo-activation has been suggested to possibly heighten efficacy. Nevertheless, there are no RCTs evaluating the use of photo-activated PRP in knee osteoarthritis.

Qual era a principal questão de investigação?

Are there any significant differences in effect on pain or function between intra-articular injections of photo-activated platelet-rich plasma and hyaluronic acid in patients with knee osteoarthritis, assessed over 3 month follow-up?

Caraterísticas do estudo +
Population:
23 patients with Kellgren-Lawrence grade II-III knee osteoarthritis.
Intervention:
PRP group: PRP was prepared from 48.5mL of peripheral blood and centrifuged with a double-spin technique (5 min at 2000rpm, obtaining the PRP phase, then 3 min at 3000 rpm). The PRP was then treated with 0.2mL sodium bicarbonate, and then lastly with low-level ultraviolet light irradiation for 5 minutes. Injections were performed 3 times over weekly intervals. (n=12; 10 analyzed) (Mean age: 49.91 +/- 13.72)
Comparison:
HA group: Participants were administered injections of hyaluronic acid (Synvisc Hylan G-F 20). Injections were performed 3 times over weekly intervals. (n=11; 9 analyzed) (Mean age: 52.70 +/- 10.30)
Outcomes:
Outcomes included a visual analog scale (VAS) for pain, the Knee Injury and Osteoarthritis Outcome Scale (KOOS), the Knee Quality of Life 26-Item questionnaire (KQoL-26), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and functional performance, including the single leg hop test the number of knee bends able to be performed in 30 seconds.
Methods:
RCT; Pilot-study
Time:
Outcomes were assessed at baseline, and at 4 and 12-week follow-up
Quais foram os resultados importantes?
  • There were no significant differences in VAS pain scores between the PRP group and the HA group at either 4 weeks (MD 1.90 [-13..80, 17.60]; p=0.79) or 12 weeks (MD 18.81 [-0.62, 38.24]; p=0.06).
  • There were no significant differences in KOOS scores between the PRP group and the HA group for any subscale at 4 and 12 weeks(Symptoms, Pain, Function, Sport, QoL) (all p>0.05).
  • There were no significant differences in KQoL-26 scores between the PRP group and the HA group for any subscale at 4 and 12 weeks (Physical, Activity, Emotional) (all p>0.05).
  • There were no significant differences in the results of functional performance tests between the PRP group and the HA group at 4 and 12 weeks (all p>0.05).
De que é que me devo lembrar mais?

In the treatment of mild-moderate knee osteoarthritis, there were no significant differences in results at 4 and 12 week follow-up between three weekly intra-articular injections of photo-activated platelet-rich plasma and hyaluronic acid.

Como é que isto afectará o tratamento dos meus doentes?

The findings of this study suggest that short-term effects are similar between photo-activated platelet-rich plasma and hyaluronic acid injection therapies for symptomatic management and functional outcome in patients with mild-moderate knee osteoarthritis. Whether either therapy is truly efficacious in the treatment of this patient population is still unknown, given the mixed previous evidence of hyaluronic acid products in knee osteoarthritis treatment, the lack of placebo-controlled group in the current study, and the pilot nature of the trial. Therefore, additional randomized, placebo-controlled trials are necessary to more accurately quantify and compare the effects of these injection options in patients with knee osteoarthritis.

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OrthoEvidence. No significant short-term difference on pain & function between photo-activated PRP and HA. OE Journal. 2016;4(21):11. Available from: https://myorthoevidence.com/AceReport/Show/no-significant-short-term-difference-on-pain-function-between-photo-activated-prp-and-ha

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