Miller 2009.
Study characteristics | ||
Methods | Study design: pilot single‐blind, randomised controlled trial Setting: outpatients who report to the Royal Newcastle Hospital, New South Wales, Australia Timing: not reported Interventions: scapular taping plus physical therapy versus physical therapy Sample size: twenty‐two people were recruited. Power calculations were not reported. Analysis: intention‐to‐treat analysis executed | |
Participants | Criteria for defining the condition being treated: unilateral shoulder pain and positivity at shoulder impingement test described by Hawkins and Kennedy
Restriction on duration of symptoms: pain of more than six weeks duration
Inclusion criteria: people aged between 18 and 70 years. Written and verbal competence in the English language
Exclusion criteria: cervical spine involvement in the disorder defined by active neck movement reproducing pain in the shoulder region; presence of a glenohumeral joint adhesive capsulitis as identified by a loss of passive shoulder motion into external rotation; history of previous shoulder surgery; physiotherapy treatment for this disorder in the past four weeks; steroid injection into or around the shoulder in the past two months; demonstrable neurological deficits; poor or fragile skin condition; report of past skin reaction associated with the use of adhesive tape
Baseline characteristics:
Intervention: Kinesio Taping (KT)
Number randomised: 10
Number included in analyses: 6 (4 lost to follow‐up)
Age (median (interquartile range)): 62 (51–67)
Sex: M 3; F 7
Diagnosis: subacromial impingement syndrome
Duration of symptoms (median (interquartile range)): 16 (7–26) weeks Median (IQR) pain (SPADI pain): 54.6 (43.6‐69.1) Median (IQR) function (SPADI): 47.7 (39.4‐62.8) Control: Physical therapy (PT) Number randomised: 12 Number included in analyses: 11 (1 lost to follow‐up) Age (median (interquartile range)): 54.5 (45.5–62.5) Sex: M 7; F 5 Diagnosis: subacromial impingement syndrome Duration of symptoms (median (interquartile range)): 17 (12–65) weeks Median (IQR) pain (SPADI pain): 60 (32.7‐67.3) Median (IQR) function (SPADI): 54.4 (27.2‐65.1) Pretreatment group differences: at baseline, the control group had a significantly lower median age and a greater number of male participants than the taped group. |
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Interventions | Intervention: KT Tape: 50 mm hypoallergenic polyacrylate adhesive bandage over which was laid a 38 mm premium non‐elastic zinc oxide adhesive tape; taping method: scapular taping; target: deltoid, lower trapezius; number of applications: 6; single application duration: 2 dd; provider: trained physiotherapists. Co‐intervention: routine physiotherapy treatment as indicated in an individual assessment of the participants' condition by their treating physiotherapist Control: Physical Therapy Routine physiotherapy treatment as indicated in an individual assessment of the participants' condition by their treating physiotherapist | |
Outcomes | Measurement occurred prior to randomisation at baseline and then at 2 weeks and 6 weeks following the commencement of treatment.
Outcomes used in this review The following outcomes were considered at the end of treatments:
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Notes | Financial support from the Division of Allied Health, Hunter Area Health Service, Australia Conflict of interest: not reported Trial registration: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation list was created using a random number table. |
Allocation concealment (selection bias) | Low risk | Sequentially numbered sealed opaque envelopes |
Blinding of participants (performance bias) | High risk | "A randomized, single‐blind clinical trial design was used..All participants were then assessed by a blinded research assistant using standard physiotherapy measures.." |
Blinding of personnel (performance bias) | High risk | "All participants were then assessed by a blinded research assistant using standard physiotherapy measures". |
Blinding of outcome assessment (detection bias) self‐reported outcomes | High risk | "All participants were then assessed by a blinded research assistant using standard physiotherapy measures". However, participants were not blinded. |
Blinding of outcome assessment (detection bias) assessor‐reported outcomes | Low risk | Appropriate measurements for assessor‐reported outcomes (i.e. active ROM) |
Incomplete outcome data (attrition bias) All outcomes | High risk | "One further limitation arose as a consequence of the differential rate of loss to follow‐up. Ideally, this pilot study should have been analyzed using an intention to treat analysis whereby all participants’ data would be included in the final analysis". |
Selective reporting (reporting bias) | Unclear risk | No protocol published |
Unequal use of co‐intervention | Low risk | KT with other conservative treatment versus the same conservative treatment |