Yadav 2015.
Study characteristics | ||
Methods |
Design: single‐centre 2‐arm parallel randomised controlled trial Setting: Safdarjang Hospital, New Delhi, India Timing: between October 2012 and April 2014 Interventions: platelet‐rich plasma (PRP) injection vs glucocorticoid injection Sample size: sample size calculation not done Analysis: data for those who completed the study were analysed |
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Participants |
Number of participants Number screened: not reported Number excluded: not reported Number randomised: 65 (numbers to PRP group and glucocorticoid group not reported) Numbers included in analysis at 3 months: 60 (30 in PRP group, 30 in glucocorticoid group) Inclusion criteria
Exclusion criteria
Baseline characteristics PRP group
Glucocorticoid group
Pre‐treatment group differences: no baseline differences were found between the 2 groups |
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Interventions |
Platelet‐rich plasma (PRP) injection Participants received a single injection of PRP (1 mL), with absolute platelet count of 1 million platelets/mm³ as confirmed by manual counting. PRP was prepared under aseptic conditions as per the procedure standardised in the departmental laboratory. A 9001:2000 ISO certified R‐23 centrifuge was used for the purpose of platelet concentration. PRP was injected into the common extensor origin at the lateral epicondyle of the humerus under aseptic conditions Glucocorticoid injection Participants received a single injection of glucocorticoid (methylprednisolone, 40 mg in 1 mL). The site of injection and the technique used were the same in both groups Post intervention Only paracetamol (500 mg) tablets were allowed as rescue medication for a maximum period of 1 week in both groups |
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Outcomes | Outcomes were measured at baseline and at 15 days, 1 month, and 3 months Study outcomes
Outcomes used in this review
Time pointsused in this review 1 month and 3 months |
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Notes |
Funding: not reported Trial registration: not done Withdrawals: 5/65 were lost to follow‐up; however group‐wise numbers were not reported Adverse events PRP injection group Total adverse events No. of events = 0 Serious adverse events No. of events = 0 Glucocorticoid injection group Total adverse events No. of events = 0 Serious adverse events No. of events = 0 Data analysis: 1‐month data were entered for the 6‐week time point analysis. Study authors did not report standard deviation for the groups. We calculated SD for pain, function, and grip strength using reported P values. At 3 months, P values were reported as P < 0.0001; thus we could not calculate SD, therefore we imputed it using SD from 4‐week analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment was not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study authors do not describe any method of blinding, and blood was likely not drawn in the glucocorticoid group. Thus, participants must have been aware of the intervention they received. There was no report of interventionists being blinded |
Blinding of outcome assessment (detection bias) for self reported subjective outcomes (pain, function, treatment success, quality of life) | High risk | As participants most likely were not blinded, there is high risk of bias in the measurement of self‐reported outcomes |
Blinding of outcome assessment (detection bias) objective outcomes | Unclear risk | It is unclear whether assessors measuring grip strength were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 5/65 (7.6%) participants were lost to follow‐up, but study authors did not report group‐wise missing data. Data from these 5 participants were excluded from the analysis |
Selective reporting (reporting bias) | Unclear risk | Study protocol was not available and the trial was not registered; measures of variance for study outcomes were not reported |
Other bias | Low risk | None is apparent |