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

Simsek 2013.

Study characteristics
Methods Study design: a randomised, double‐blind, controlled clinical trial
Setting: not reported
Timing: not reported
Interventions: therapeutic kinesio taping and exercise therapy versus sham kinesio taping and exercise therapy
Sample size: thirty‐eight (25 female, 13 male) patients with SIS were randomly divided into therapeutic KT (n = 19) and sham KT (n = 19) groups. A minimum of 17 patients per group was necessary for 80% statistical power.
Analysis: intention‐to‐treat analysis executed
Participants Criteria for defining the condition being treated: pain interfering with the patient’s daily routine and positivity at Neer and Hawkin’s impingement tests
Restriction on duration of symptoms: pain lasting for one month or longer
Inclusion criteria: patients between the ages of 18 and 70
 
Exclusion criteria: calcific tendinitis and degenerative arthritis in plain roentgenograms, pathological findings in addition to subacromial effusion in MR images, a history of shoulder, waist and chest surgery, fracture or dislocation of the affected shoulder, cervical problems accompanied by radicular symptoms, inflammatory joint disease, and physiotherapy for the shoulder within last three months

Baseline characteristics:
Overall cohort of participants:
Number of participants at enrolment: 38
Number randomised: 38
Number included in analyses: 38
Age: 51 years, range: 18 to 69 years
Sex: M 13; F 25
Diagnosis: subacromial impingement syndrome
 
Intervention: Kinesio Taping (KT)
Number randomised: 19
Number included in analyses: 19
Age: 48 years
Sex: M 8; F 11
Dominant shoulder affected: 52%
Duration of symptoms: 10.37 ± 8.26 months
Mean (SD) pain (VAS 0‐10): 2.74 (2.73)
Mean (SD) function (DASH): 46.15 (19.83)
Control: Sham Taping (ST)
Number randomised: 19
Number included in analyses: 19
Age: 53 years
Sex: M 5; F 14
Dominant shoulder affected: 63%
Duration of symptoms: 10.37 ± 6.65 months
Mean (SD) pain (VAS 0‐10): 3.21 (2.92)
Mean (SD) function (DASH): 52.69 (16.42)
Pretreatment group differences: shoulder flexion strength, active ROM in flexion, painless ROM during internal rotation
Interventions Interventions:
Tape: kinesio tape 2 in (5 cm); taping method: Kase protocol; target: deltoid, supraspinatus; number of applications: 4; single application duration: 3 dd; provider: certified physiotherapist. 
Co‐intervention: patients were given exercises defined by Hughston and Riivald. All exercises were begun with 5 repeats and increased to 15 repeats, as tolerated. Training was performed once a day, for 5 days a week under supervision of a physiotherapist and lasted two weeks. Patients were asked to repeat the exercises as one set during weekdays and two sets on weekends at home.
Control: sham kinesio tape
Co‐intervention: patients were given exercises defined by Hughston and Riivald. All exercises were begun with 5 repeats and increased to 15 repeats, as tolerated. Training was performed once a day, for 5 days a week under supervision of a physiotherapist and lasted two weeks. Patients were asked to repeat the exercises as one set during weekdays and two sets on weekends at home.
Outcomes All assessments were performed before the treatment and on the 5th and 12th days:
  • function:

    • disabilities of the arm

    • Shoulder and Hand (DASH) questionnaire

    • Constant score

  • pain on motion: visual analogue scale (VAS) (0‐10)

  • free of pain active range of motion: goniometer

  • pain at night: visual analogue scale (VAS) (0‐10)

  • pain at rest: visual analogue scale (VAS) (0‐10)

  • active range of motion (ROM) (shoulder flexion, extension, abduction, internal and external rotation): goniometer

  • muscle strength: baseline ®hand dynamometer (Fabrication Enterprises Inc., NY, USA) (isometric)


Outcomes used in this review
The following outcomes were considered at the end of treatments:
  • Pain (VAS 0‐10)

  • Pain on motion (VAS 0‐10)

  • Active range of motion ‐ free of pain (ROM)

  • Function (DASH)

  • Muscle strength: baseline ®hand dynamometer (Fabrication Enterprises Inc., NY, USA) (isometric)

Notes Funding: Scientific Research Project Fund of Cumhuriyet University
Conflict of interest: none
Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Thirty‐eight (25 female, 13 male) patients with SIS were randomly divided into therapeutic KT (n = 19) and sham KT (n = 19) groups". No information for judgement
Allocation concealment (selection bias) Unclear risk "Thirty‐eight (25 female, 13 male) patients with SIS were randomly divided into therapeutic KT (n = 19) and sham KT (n = 19) groups". No information for judgement
Blinding of participants (performance bias) Unclear risk Poor reporting prevented any judgement.
Blinding of personnel (performance bias) Unclear risk Poor reporting prevented any judgement.
Blinding of outcome assessment (detection bias)
self‐reported outcomes Unclear risk "Assessments were performed before the treatment and on the 5th and 12th days by a researcher blinded to the information about the patient and the group". However, no information for blinding of participants was present.
Blinding of outcome assessment (detection bias)
assessor‐reported outcomes Low risk Appropriate measurements for assessor‐reported outcomes (i.e. ROM and muscle strength). "Assessments were performed before the treatment and on the 5th and 12th days by a researcher blinded to the information about the patient and the group".
Incomplete outcome data (attrition bias)
All outcomes Unclear risk It was not clear whether participants were lost to follow‐up. 
Selective reporting (reporting bias) Unclear risk No protocol published
Unequal use of co‐intervention Low risk KT with co‐intervention versus sham taping with the same co‐intervention