Miccinilli 2018.
Study characteristics | ||
Methods | Study design: monocentric prospective double‐blind randomised controlled trial Setting: outpatients who report to the Department of Physical and Rehabilitation Medicine of Campus Bio‐Medico, University of Rome Timing: between September 2016 and December 2017 Interventions: KT application plus standardised rehabilitative protocol of exercises versus sham KT application plus the same standardised rehabilitative protocol of exercises Sample size: 42 patients were randomised; 40 participants completed the study. Power calculation was not reported. Analysis: per‐protocol analysis was executed. | |
Participants | Criteria for defining the condition being treated: radiologic diagnosis of rotator cuff tendinopathy (RoCT) with evidence of pathognomonic signs at musculoskeletal echography or magnetic resonance; clinical positivity to at least one of the specific shoulder tests for RoCT shoulder pain
Exclusion criteria: total tendon lesion; previous fracture or shoulder dislocation; presence of skin lesions contraindicating the application of KT; coexisting elbow, forearm, wrist, hand and fingers pathologies; history of neoplasm; cognitive impairment (MMSE < 24); diabetes mellitus; statin use; diagnosis of anxiety‐depressive syndrome
Baseline characteristics:
Intervention: Kinesio Taping (KT)
Number randomised: 21
Number included in analyses: 21
Age: 61 ± 12 years
Sex: M 9; F 12
Diagnosis: rotator cuff tendinopathy
Median (IQR) pain (NRS 0‐10): 3 (1‐3) Median (IQR) function (Constant score): 44 (40‐53) Control: Sham Taping (ST) Number randomised: 21 Number included in analyses: 19 Age: 64 ± 10 years Sex: M 9; F 10 Diagnosis: rotator cuff tendinopathy Median (IQR) pain (NRS 0‐10): 2 (1‐3.5) Median (IQR) function (Constant score): 42 (38‐51.5) Pretreatment group differences: no between‐group differences were observed. |
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Interventions | Intervention: KT Tape: not reported; taping method: Kase protocol; target: deltoid, glenohumeral articulation, rhomboid; number of applications: 6; single application duration: 2 dd; provider: physiotherapist Co‐interventions: 10 sessions of rehabilitative treatment, from Monday to Friday for two consecutive weeks, consisting of:
Control: ST Decompressive deltoid‐like application, functional‐like application and a rhomboid‐like application. Taping was positioned without tensioning, with limb in neutral position, without joint involvement (exclusion of the humeral head for the deltoid‐like application, exclusion of the vertebral column for the rhomboid‐like application) Co‐interventions: 10 sessions of rehabilitative treatment, from Monday to Friday for two consecutive weeks, consisting of:
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Outcomes | Measures pre/post‐treatment:
Outcomes used in this review The following outcomes were considered at the end of treatments:
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Notes | Funding: not reported Conflict of interest: not reported Trial registration: not reported Adverse events: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "subjects were randomly assigned to two groups by another examiner using the envelope system (1:1)". Insufficient information for judgement |
Allocation concealment (selection bias) | Low risk | "subjects were randomly assigned to two groups by another examiner using the envelope system (1:1)". Insufficient information for judgement |
Blinding of participants (performance bias) | Unclear risk | "The examiner was blind to real/sham taping treatment. However, the blinding of participants was unclear". |
Blinding of personnel (performance bias) | High risk | "Even if the physiotherapist involved in rehabilitative treatment was blind to the type of taping application, the application of KT can be recognized for shaping application". |
Blinding of outcome assessment (detection bias) self‐reported outcomes | Unclear risk | "The examiner was blind to real/sham taping treatment. However, the blinding of participants was unclear". |
Blinding of outcome assessment (detection bias) assessor‐reported outcomes | Low risk | The examiner was blind to real/sham taping treatment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No high percentage and unbalanced loss to follow‐up. No information for intention‐to‐treat analysis |
Selective reporting (reporting bias) | High risk | No protocol published; discrepancy between Methods and Results sections in outcomes declared |
Unequal use of co‐intervention | Low risk | KT with co‐intervention versus sham taping with the same co‐intervention |