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

Thelen 2008.

Study characteristics
Methods Study design: prospective, randomised, double‐blinded, clinical trial using a repeated‐measures design
Setting: the Cadet Physical Therapy Clinic at the United States Military Academy or Keller Army Community Hospital at West Point, NY
Timing: September 2006 to September 2007
Interventions: 2 groups: therapeutic KT group or sham KT group
Sample size: forty‐two subjects clinically diagnosed with rotator cuff tendonitis/impingement were recruited. A priori power analysis demonstrated the need for at least 26 subjects per group, given a standard deviation of 25 mm (VAS), a difference in pain intensity between groups of 20 mm on the VAS, an alpha level of.05, and with power set at 80%.
Analysis: to account for the missing data, the authors performed an intention‐to‐treat analysis utilising the last‐observation‐carried‐forward (LOCF) model. This technique involves using the last recorded value for each outcome measure and applying it to the remaining missing value(s).
Participants Criteria for defining the condition being treated: pain onset prior to 150° of active shoulder elevation in any plane, positive Empty can test indicating 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 not longer than 6 months

Inclusion criteria: being 18 to 50 years of age

Exclusion criteria: shoulder girdle fracture, glenohumeral dislocation/subluxation, acromioclavicular sprain, concomitant cervical spine symptoms, a history of shoulder surgery within the previous 12 weeks
Baseline characteristics:
Intervention: Kinesio Tape ‐ KT
Number of participants at enrolment: 21
Number randomised: 21
Number included in analyses: 21 (3 lost to follow‐up)
Age: 21.3 ± 1.7 years
Sex: M 19; F 2
Diagnosis: Shoulder pain
Duration of symptoms (d): 19 (5‐35)
Mean (SD) pain (VAS 0‐100): 44.1 (20.1)
Mean (SD) function (SPADI): 37.4 (15.2)
Comparator: Sham Tape ‐ ST
Number of participants at enrolment: 21
Number randomised: 21
Number included in analyses: 21 (4 lost to follow‐up)
Age: 19.8 ± 1.5 years
Sex: M 17; F 4
Diagnosis: Shoulder pain
Duration of symptoms (d): 8 (5‐30)
Mean (SD) pain (VAS 0‐100): 43.9 (21.7)
Mean (SD) function (SPADI): 34 (13.9)
Pretreatment group differences: no meaningful differences existed between groups at baseline.
Interventions Intervention: Kinesio Taping
Tape: Kinesio tape 2 in (5 cm); taping method: Kase protocol; target: deltoid, supraspinatus, glenohumeral articulation; number of applications: 2; single application duration: 6 dd; provider: certified clinician
Control: Sham Taping
In this study, authors used an alternative sham taping application. The sham group sites were selected because they were the most common locations of perceived pain by patients with rotator cuff tendonitis or impingement.
 
Outcomes
  • Shoulder pain and disability: Shoulder Pain and Disability Index (SPADI). The minimal clinically important change defined as greater than a 10‐point decrease in score. SPADI was measured at baseline, 3 days and 6 days after tape application.

  • Pain intensity at the endpoint of pain‐free active shoulder ROM: the authors utilised a 100 mm VAS to record the pain intensity experienced at the endpoint of the pain‐free active ROM test.

  • Pain at rest: 0 to 100 mm visual analogue scale (VAS), measured at baseline, immediately after taping, 3 days and 6 days after tape application

  • Pain‐free active range of motion (ROM): shoulder ROM measurements of forward flexion, abduction, and scapular plane elevation were taken using a standard goniometer. ROM measurements were obtained at baseline, immediately after taping, 3 days and 6 days after tape application.

  • Adverse events


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

  • Pain‐free active range of motion (ROM)

  • Function (SPADI)

  • Adverse events

Notes Funding: none
Conflict of interest: none
Trial registration: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Subjects were assigned to 1 of 2 groups using a random‐number generator and allocation was concealed".
Allocation concealment (selection bias) Low risk "Subjects were assigned to 1 of 2 groups using a random‐number generator and allocation was concealed".
Blinding of participants (performance bias) Low risk "Although the taping applications looked different, they were well concealed under short‐sleeve clothing. Therefore, we do not believe that blinding of the subjects was compromised".
Blinding of personnel (performance bias) High risk "Prospective, randomised, double‐blinded, clinical trial"
Blinding of outcome assessment (detection bias)
self‐reported outcomes Low risk "To avoid bias, the second author, who was blinded to the group assignment, measured outcomes". In addition, "although the taping applications looked different, they were well concealed under short‐sleeve clothing. Therefore, we do not believe that blinding of the subjects was compromised".
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 Low risk No high percentage and unbalanced loss to follow‐up
Selective reporting (reporting bias) Unclear risk No published protocol
Unequal use of co‐intervention Low risk No co‐interventions

AAOS:American Academy of Orthopaedic Surgeons (AAOS)ACJ:Acromioclavicular Joint (ACJ)ADL:Activities of daily livingANOVA:Analysis of varianceASES‐100:American Shoulder and Elbow Surgeons (ASES) Shoulder Score BMI:Body Mass IndexBPI:Brief Pain InventoryC‐M: Constant–Murley scale

cm: centimeter

CTT: control Tension Taping DASH:Disability of the Arm, Shoulder and Handdd:daysEMG: ElectromyographyESWT:Extracorporeal Shock Wave TherapyEX:exerciseFLEX‐SF:Self‐reported flexi‐level scale of shoulder functionGH:Glenohumeral jointHEP:Home Exercise ProgramHILT:High‐intensity laser therapyKT: Kinesio TapingIQR: Interquartile range 
ITT:increasing Tension Taping

ITT: Intention‐to‐treat analysis

LOCF: Last‐observation‐carried‐forwardMCID:Minimal clinically important differenceMMSE:Mini‐Mental State ExaminafionMRC:Medical Research Council scaleMRI:Magnetic resonance imaging MT:Manual Therapy NA:Not availableNR:Not reportedNEER:Neer's TestNHP:Nottingham Health ProfileNPRS:Numeric pain rating scalesNSAID:Nonsteroidal anti‐inflammatory drugOSS:Oxford Shoulder ScorePAM: Passive accessory movementsPCT:Precut kinesiology tapePENN:PENN Shoulder ScorePT:Physical therapyRC:Rotator cuffRCT:Randomized controlled trialRoCT:rotator cuff tendinopathyROM:Range of MotionRSP:Round shoulder positionSAI:: subacromial impingement SAIS:subacromial impingement syndromeSD:Standard DeviationSET:Supervised exercise therapySF‐12:12‐item Short Form SurveySIS:Shoulder Impingement SyndromeSPADI:Shoulder Pain Disability IndexSSRQ:Subjective Shoulder Rating QuestionnaireSST:Simple Shoulder TestST:Sham TapingT(0)(1)(2)(3):Time pointTB‐KT:TheraBand Kinesiology TapeTENS:transcutaneous electrical nerve stimulationTTDPM:Threshold to detect passive motionUS:UltrasoundVAS:Visual Analogue ScaleWBS:Wong‐Baker Face Rating ScaleWORC:Western Ontario Rotator Cuff inde