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. 2021 Aug 8;2021(8):CD012720. doi: 10.1002/14651858.CD012720.pub2

Kaya 2011.

Study characteristics
Methods Study design: quasi‐RCT
Setting: not reported
Timing: September 2006 to December 2008
Interventions: therapeutic KT plus home exercise program (HEP) versus physical therapy modalities (ultrasound, transcutaneous electrical nerve stimulation (TENS), exercise, and hot pack) plus the same HEP
Sample size: 55 patients were enrolled in the study. The minimum sample size required for 80% statistical power and 5% significance level was 22 for each group. Estimated power for 55 subjects was calculated as 90.7%.
Analysis: per‐protocol analysis was executed. 
Participants Criteria for defining the condition being treated: pain before 150° of active shoulder elevation in any plane, positive empty can test indicating the possible supraspinatus involvement, positive Hawkins–Kennedy test indicating possible external impingement, subjective complaint of difficulty performing activities of daily living.
Restriction on duration of symptoms: shoulder pain which lasted more than 6 months

Inclusion criteria: age of 18‐70 years

Exclusion criteria: intra‐articular steroid injection, shoulder girdle fracture, glenohumeral dislocation/subluxation, acromioclavicular sprain, concomitant cervical symptoms consistent with radiculopathy, history of a shoulder surgery within the previous 12 weeks

Baseline characteristics:
Intervention: kinesio Taping (KT)
Number randomised: 30
Number included in analyses: 30
Age: 56.2 ± 7.2 years
Sex: ND
Diagnosis: subacromial impingement syndrome
Duration of symptoms: 6.3 ± 4.3 months
Mean (SD) pain (VAS 0‐100): 42 (29.5)
Mean (SD) function (DASH): 58.6 (16.5)
Comparator: physical therapy (PT)
Number randomised: 30
Number included in analyses: 25 (5 lost to follow‐up)
Age: 59.5 ± 7.9 years
Sex: ND
Diagnosis: subacromial impingement syndrome
Duration of symptoms: 7.2 ± 4.9 months
Mean (SD) pain (VAS 0‐100): 54 (28.3)
Mean (SD) function (DASH): 56.6 (17.8)
Pretreatment group differences: no between‐group differences were observed. 
Interventions Intervention: KT
Tape: Kinesio tape 2 in (5 cm); taping method: Kase protocol; target: deltoid, supraspinatus, teres minor; number of applications: 3; single application duration: 3 dd; provider: the same physician. Co‐intervention: home exercise program
HEP consisted of isometric exercises, range of motion, strengthening (serratus anterior, trapezius, and external rotation) and stretching (posterior shoulder and pectoralis minor), and relaxation of the trapezius twice a day.

Control: PT
A daily program of physical therapy modalities (ultrasound, transcutaneous electrical nerve stimulation (TENS), exercise, and hot pack). Intermittent ultrasound of 1 MHz and 1 W/cm2 for 5 min was used daily. TENS and hot pack were applied 20 min a day.
Co‐intervention: Home Exercise Program
HEP consisted of isometric exercises, range of motion, strengthening (serratus anterior, trapezius, and external rotation) and stretching (posterior shoulder and pectoralis minor), and relaxation of the trapezius twice a day.
Outcomes All measures were obtained at baseline, and at first (except for the DASH) and second weeks of the treatment
  • Disability of the arm: the disability of the arm, shoulder and hand scale (DASH)

  • Pain:

    • pain intensity scores at rest: 100 mm Visual Analogue Scale for pain (VAS). The patient was asked to mark the strength of his/her pain at rest on the horizontal line.

    • pain intensity scores during activity: 100 mm Visual Analogue Scale for pain (VAS) during active movements, including shoulder abduction, forward flexion, and internal and external rotations

    • pain intensity scores at night: 100 mm Visual Analogue Scale for pain (VAS)

  • Adverse events


Outcomes used in this review
The following outcomes were considered at the end of treatments:
  • Pain (VAS 0‐100)

  • Function (DASH)

  • Adverse events


 
Notes Funding: not reported
Conflict of interest: not reported
Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "Subjects were assigned to two groups according to their date of admittance".
"The lack of randomization and sequential allocation of patients are also other factors that weaken the power of this study".
Allocation concealment (selection bias) High risk "The lack of randomization and sequential allocation of patients are also other factors that weaken the power of this study".
Blinding of participants (performance bias) High risk Nature of delivered intervention
Blinding of personnel (performance bias) High risk Nature of delivered intervention
Blinding of outcome assessment (detection bias)
self‐reported outcomes High risk "KT was performed by the first author, and the assessments were carried out by the first and second authors". Participants were not blinded due to the nature of delivered interventions.
Blinding of outcome assessment (detection bias)
assessor‐reported outcomes Low risk No objective outcome planned and assessed
Incomplete outcome data (attrition bias)
All outcomes High risk "The possible existence of a drop out bias which may lead to over‐ or underestimation of our results"
Selective reporting (reporting bias) Unclear risk No published protocol
Unequal use of co‐intervention Low risk KT with co‐intervention versus conservative treatment with the same co‐intervention