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. |
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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 |
Outcomes used in this review The following outcomes were considered at the end of treatments:
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Notes | Funding: none Conflict of interest: none Trial registration: not reported |
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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 living ANOVA:Analysis of variance ASES‐100:American Shoulder and Elbow Surgeons (ASES) Shoulder Score BMI:Body Mass Index BPI:Brief Pain Inventory C‐M: Constant–Murley scale
cm: centimeter
CTT: control Tension Taping DASH:Disability of the Arm, Shoulder and Hand dd:days EMG: Electromyography ESWT:Extracorporeal Shock Wave Therapy EX:exercise FLEX‐SF:Self‐reported flexi‐level scale of shoulder function GH:Glenohumeral joint HEP:Home Exercise Program HILT:High‐intensity laser therapy KT: Kinesio Taping IQR: Interquartile range ITT:increasing Tension Taping
ITT: Intention‐to‐treat analysis
LOCF: Last‐observation‐carried‐forward MCID:Minimal clinically important difference MMSE:Mini‐Mental State Examinafion MRC:Medical Research Council scale MRI:Magnetic resonance imaging MT:Manual Therapy NA:Not available NR:Not reported NEER:Neer's Test NHP:Nottingham Health Profile NPRS:Numeric pain rating scales NSAID:Nonsteroidal anti‐inflammatory drug OSS:Oxford Shoulder Score PAM: Passive accessory movements PCT:Precut kinesiology tape PENN:PENN Shoulder Score PT:Physical therapy RC:Rotator cuff RCT:Randomized controlled trial RoCT:rotator cuff tendinopathy ROM:Range of Motion RSP:Round shoulder position SAI:: subacromial impingement SAIS:subacromial impingement syndrome SD:Standard Deviation SET:Supervised exercise therapy SF‐12:12‐item Short Form Survey SIS:Shoulder Impingement Syndrome SPADI:Shoulder Pain Disability Index SSRQ:Subjective Shoulder Rating Questionnaire SST:Simple Shoulder Test ST:Sham Taping T(0)(1)(2)(3):Time point TB‐KT:TheraBand Kinesiology Tape TENS:transcutaneous electrical nerve stimulation TTDPM:Threshold to detect passive motion US:Ultrasound VAS:Visual Analogue Scale WBS:Wong‐Baker Face Rating Scale WORC:Western Ontario Rotator Cuff inde