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. 2021 Sep 30;2021(9):CD010951. doi: 10.1002/14651858.CD010951.pub2

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
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
  • Tenderness over lateral epicondyle and pain on wrist extension

  • Diagnosis confirmed as heterogeneity, and neovascularity of common extensor tendon origin assessed via ultrasound by 1 of 2 musculoskeletal radiology consultants with over 5 years' experience

  • Minimum symptom duration 6 months

  • Failure of conservative treatment including physiotherapy and glucocorticoid injection


Exclusion criteria
  • Previous elbow trauma or surgery

  • Local injection or recent steroid in the past 3 months

  • History of inflammatory arthropathy

  • Tendon tear


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
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
Outcomes Outcomes were reported at baseline and at 2 months and 6 months
Outcomes
  • Mean pain measured on a visual analogue scale. Score scale from 0 (no pain) to 10 (maximum pain)

  • Mean elbow function measured by the Nirschl staging system. Score scale from 0 (constant pain at rest, poor function) to 80 (no pain, improved function)

  • Treatment success as defined by 25% reduction in pain on a visual analogue scale

  • Adverse events

  • Withdrawals due to adverse events


Outcomes included in this review
  • Mean pain measured on a visual analogue scale

  • Mean elbow function measured by the Nirschl staging system

  • Treatment success as defined by 25% reduction in pain on a visual analogue scale

  • Adverse events

  • Withdrawals due to adverse events


Time points included in this review
2 months and 6 months
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
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