Stenhouse 2013.
Study characteristics | ||
Methods |
Design: single‐centre unblinded parallel 2‐arm randomised controlled trial Setting: Rheumatology or Orthopaedic Outpatient Clinic, West Middlesex University Hospital, Middlesex, United Kingdom Timing: June 2010 to August 2012 Interventions: autologous conditioned plasma injection and dry needling vs dry needling Sample size: not reported Analysis: data for participants who completed the study were analysed |
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Participants |
Number of participants Number of participants screened for eligibility: not reported Number excluded: not reported Number randomised: 28 (15 in autologous blood group, 13 in dry needling group) Number included in analysis: 25 (13 in autologous blood group, 12 in dry needling group) Inclusion criteria
Exclusion criteria
Baseline characteristics Autologous conditioned plasma and dry needling group Mean (SD) age (years): 53.2 (9.87) No. male:female: 8:7 Mean (SD) duration of pain (months): 18.9 (17.8) Dominant arm affected: 13 (86.6%) Mean (SD) VAS pain score (0 to 10; 0 is no pain): 8.07 (1.18) Mean (SD) Nirschl stage (80 to 0; 80 is no pain): 11.1 (14.3) Dry needling group Mean (SD) age (years): 47.6 (6.12) No. male:female: 5:8 Mean (SD) duration of pain (months): 22.2 (14.5) Dominant arm affected: 11 (84.6) Mean (SD) VAS pain score (0 to 10; 0 is no pain): 6.87 (2.15) Mean (SD) Nirschl stage (0 to 80; 80 is no pain): 22.9 (19.1) Pretreatment group differences: Nirschl scores were higher in the dry needling group compared with the ACP and dry needling group |
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Interventions | The abnormal common extensor origin tendon was identified with a 15 L 8‐W transducer on a GE Logiq E9 ultrasound machine (Milwaukee, WI). Before treatment, the skin was cleaned with antiseptic solution and 1 to 2 mL of 1 % lignocaine was injected immediately deep into the deep fascia with a 23‐G needle. Care was taken to avoid local anaesthetic injection into the tendon. Following a short interval (to allow the anaesthetic to act), the patient was treated with either dry needling alone or dry needling followed by ACP injection. The procedure was repeated at 1 month Autologous conditioned plasma and dry needling group Participants had 10 mL of blood taken from their contralateral antecubital vein. The ACP double syringe (manufactured by Arthrex Double Syringe System, Inc., Naples, FL) containing whole blood was then centrifuged at 1500 rpm for 5 minutes. This separated red blood cells from platelet‐containing plasma. The plasma was drawn into the smaller syringe. Dry needling was performed initially for 2 minutes followed by a 2‐mL injection of ACP Dry needling group Dry needling consisted of passing a fine needle (23G) in and out through the long axis of the tendon without exiting the skin approximately 40 to 50 times to pepper the tendon. This lasted a total of 2 minutes Follow‐up care Participants were advised to undertake normal activities but to avoid anything that may aggravate symptoms |
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Outcomes | Outcomes were reported at baseline and at 2 months and 6 months Outcomes
Outcomes included in this review
Time points included in this review 2 months and 6 months |
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Notes |
Funding: not reported Trial registration: not done Withdrawals: 2/15 in the autologous blood group and 1/13 in the dry needling group were lost to follow‐up due to increasing elbow pain after the first treatment Adverse events Autologous conditioned plasma and dry needling group Total adverse events: 2/15 No. of events: 2 Nature of event: increased elbow pain after first treatment Serious adverse events: none reported Dry needling group Total adverse events: 1/13 No. of events: 1 Nature of event: increased elbow pain after first treatment Serious adverse events: none reported Although study authors reported no adverse events in either group, 3 participants were lost from the study ‐ 2 from the autologous blood group and 1 from the dry needling group ‐ due to increasing elbow pain after first injection. We regarded these data as withdrawal due to adverse events and documented increased elbow pain following treatment as an adverse event |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was performed using an Internet platform called 'research randomised form v4.0'” |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not adequately reported in the article |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded to group allocation; study authors report "a separate investigator was enrolled to evaluate the outcome measures" |
Blinding of outcome assessment (detection bias) for self reported subjective outcomes (pain, function, treatment success, quality of life) | High risk | As participants were not blinded to treatment allocation, there is risk of bias in the measurement of pain and function |
Blinding of outcome assessment (detection bias) objective outcomes | Low risk | There were no truly objective outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2/15 (13%) in the autologous blood group and 1/13 (7.7%) in the dry needling group were discontinued after first intervention due to increased elbow pain after the first injection |
Selective reporting (reporting bias) | Unclear risk | No protocol was found and the trial was not registered |
Other bias | Low risk | No other bias was found |