Pekyavas 2016.
| Study characteristics | ||
| Methods | Study design: randomised controlled trial Setting: not reported Timing: not reported Interventions: four groups: 1. exercise (EX); 2. Kinesio Tape (KT) + EX; 3. Manual Therapy + KT + EX; 4. MT + KT + high‐intensity laser therapy (HILT) + EX Sample size: seventy‐five patients were recruited for the study. The power analysis indicated that 15 participants for each group were needed with 80% power and a 5% type 1 error. Analysis: per‐protocol analysis was executed. | |
| Participants | Criteria for defining the condition being treated: shoulder pain (5/10 points from visual analogue scale) and diagnosis of SAIS by a physical medicine and rehabilitation doctor
Restriction on duration of symptoms: symptoms for at least 3 months prior to admission
Exclusion criteria: soft tissue or bone problems affecting the shoulder; acute inflammation affecting the shoulder region; neurologic problems; scoliosis; systematic rheumatic problems; undergone orthopaedic problems or surgery affecting neck; obese (BMI > 30 kg/m2)
Baseline characteristics:
Overall cohort of participants:
Number of participants at enrolment: 75
Number randomised: 70
Number included in analyses: 70
Age (mean and SD): 47.1 ± 13.8 years
Diagnosis: subacromial impingement syndrome
Control: Exercise (EX)
Number randomised: 15
Number included in analyses: 15
Age: 40.6 ± 11.7 years
Mean (SD) pain (SPADI pain): 67.20 (11.48) Mean (SD) function (SPADI): 44.73 (17.17) Intervention: Kinesio Taping (KT) + exercise (EX) Number randomised: 20 Number included in analyses: 20 Age: 49.4 ± 12.6 years Mean (SD) pain (SPADI pain): 55.80 (21.16) Mean (SD) function (SPADI): 72.65 (30.13) Intervention: (KT) + (EX) + Manual Therapy (MT) Number randomised: 16 Number included in analyses: 16 Age: 45.4 ± 15.5 years Mean (SD) pain (SPADI pain): 74.43 (5.25) Mean (SD) function (SPADI): 111 (16.92) Intervention: (KT) + (EX) + (MT) + High‐Intensity Laser Therapy [HILT] Number randomised: 19 Number included in analyses: 19 Age: 51.1 ± 14.3 years Mean (SD) pain (SPADI pain): 76.42 (4.88) Mean (SD) function (SPADI): 114.89 (11.94) Pretreatment group differences: no statistically significant differences were observed between the groups at baseline. |
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| Interventions | Intervention: KT
Tape: not reported; taping method: Kase protocol; target: deltoid, supraspinatus, glenohumeral articulation; number of applications: 5; single application duration: 3 dd; provider: not reported. Co‐intervention: Home Exercise Program: All the patients were instructed to perform the active ROM, stretching, and strengthening exercise program including rotator cuff muscles, rhomboids, levator scapulae, and serratus anterior with a Thera‐Band at home at least seven times a week for 10–15 min. The exercises were taught by a physiotherapist, and all the patients did the exercises every day during the 3 weeks without fail.
Intervention: MT
Manual treatment consisted of deep friction massage on the supraspinatus muscle, radial nerve stretching, scapular mobilisation, glenohumeral joint mobilisation, and proprioceptive neuromuscular facilitation techniques. Co‐intervention: Home Exercise Program and kinesio taping
Intervention: HILT
HILT group received HILT with a neodymium‐yttrium aluminium garnet laser having a pulsating waveform produced by an HIRO® 3.0 device reaching very high power peaks (3 kW) with an Nd:YAG pulsed source (wavelength 1064 nm). The total dose of energy administered was approximately 2050 J. The total time taken to apply all the three stages of HILT was approximately 30 min. Co‐intervention: Home Exercise Program, kinesio taping and manual therapy Intervention: Home Exercise Program All the patients were instructed to perform the active ROM, stretching, and strengthening exercise program including rotator cuff muscles, rhomboids, levator scapulae, and serratus anterior with a Thera‐Band at home at least seven times a week for 10–15 min. The exercises were taught by a physiotherapist, and all the patients did the exercises every day during the 3 weeks without fail. |
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| Outcomes | Outcomes were assessed before and at the end of the treatment (15th day).
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: 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 | "online random allocation software program" |
| Allocation concealment (selection bias) | Unclear risk | "online random allocation software program". It was not clear how and who performed the allocation. |
| Blinding of participants (performance bias) | High risk | "All patients were assessed by an experienced physiotherapist, and the treatments were performed by another experienced physiotherapist in order to provide a single blind structure of the study". |
| Blinding of personnel (performance bias) | High risk | "All patients were assessed by an experienced physiotherapist, and the treatments were performed by another experienced physiotherapist in order to provide a single blind structure of the study". |
| Blinding of outcome assessment (detection bias) self‐reported outcomes | High risk | "All patients were assessed by an experienced physiotherapist, and the treatments were performed by another experienced physiotherapist in order to provide a single blind structure of the study". However, participants were not blinded. |
| Blinding of outcome assessment (detection bias) assessor‐reported outcomes | Low risk | Appropriate measurements for assessor‐reported outcome (i.e. active ROM) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Completed flow chart; no dropouts |
| Selective reporting (reporting bias) | Unclear risk | No protocol published |
| Unequal use of co‐intervention | High risk | Multi‐arm trial with KT in combination with other conservative treatment versus conservative treatment |