Evcik 2010.
Methods | Prospective, single‐centre, single‐blinded, randomised controlled trial | |
Participants | Based in Turkey. No recruitment/study dates documented.
We assume participants are 'mixed civilian' but this is not actually stated. 86 participants were recruited (72 female, 14 male; mean age 42 years, range 17 to 80 years) diagnosed with patellofemoral pain syndrome by physicians and an orthopaedic surgeon. Two groups: Knee sleeve group: n = 41 (female 35, male 6; age 42.2 years (SD 15.3, range 17 to 80); mean duration of symptoms 24.2 months (SD 13.6, range 1 to 80)) Control group: n = 45 (female 37, male 8; age 41.0 years (SD 9.3, range 20 to 59); mean duration of symptoms 18.2 months (SD 13.2, range 1 to 72)) Inclusion criteria: Anterior or retropatellar knee pain when walking up and down stairs, squatting, kneeling or prolonged sitting for at least 4 weeks were enrolled in this study. In addition, they should have pain in at least 2 of the following physical tests: patellar compression test, in which pressure is applied over the patella while the knee is fully extended, Clarke’s test (physician places his/her hand over the patient’s patella, presses gently downwards, as the patient contracts the quadriceps muscle and the test is positive if pain occurs, which indicates patellofemoral joint problems), patellar apprehension test (the physician should be aware that patients with a history of subluxation or dislocation of the patella might feel very uncomfortable at this point and try to stop the physician from completing the test) and palpation of the posterior medial‐lateral borders of the patella. Hypermobility, measurement of Q‐angle and patellar tilt test were also applied. All participants underwent weight‐bearing anteroposterior telemetric X‐ray evaluation and tangential knee radiography in 30 and 45 degrees of flexion. Patellar subluxation (which was demonstrated by measuring the lateral PF angle), subchondral sclerosis and presence of degenerative changes were determined from these radiographs. All participants were diagnosed as having PFPS based on history, physical examination, and radiological evaluation Exclusion criteria: People with tibiofemoral compartment osteoarthritis, knee effusion, inflammatory joint pathology, infection, previous knee arthroplasty, lower extremity fracture history and severe cardiovascular diseases were excluded from the study. After the physical examination, full blood count, erythrocyte sedimentation rate (ESR), C‐reactive protein (CRP) and biochemical markers were evaluated in order to determine the presence of other systemic inflammatory diseases. |
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Interventions |
Knee sleeve group: Received the control group's exercise programme in addition to an Altex Patellar Knee support (Altex Patellar knee support AL‐2285C), which is a neoprene sleeve with a patella cut‐out. This was worn whilst performing the exercises as well as during the day for the six‐week study period. The knee support was only removed at night for sleeping Control group: A home‐based exercise therapy including a standardised protocol developed by a physiotherapist. This consisted of isometric and isotonic programmes for quadriceps muscles, performed five times per week. All participants performed 10 repetitions per day for six weeks. All participants provided with an exercise sheet, outlining the programme. All participants were reviewed at 2‐weekly intervals to monitor compliance to allocated treatment. |
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Outcomes | Outcomes assessed at baseline and at 6 weeks post‐commencement of the sleeve and exercise interventions Outcomes evaluated included:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Consecutive admission to the outpatient clinic. Materials and Methods (Page 101) participants were "randomly allocated to either" group, with "randomisation made according to the consecutive admissions of the patients to the outpatient clinic" This appears to be quasi‐randomised |
Allocation concealment (selection bias) | High risk | Not documented whether allocation was concealed but this seems unlikely. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of physiotherapist: Materials and Methods section (page 101): “only the therapist who applied the therapy was aware of the therapy”. Although it would be logistically difficult to blind the participants or study personnel to the intervention, the standardisation of the intervention with the exercise sheet detailing the home‐exercise programme attempted to reduce physiotherapist's potential bias. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The assessor was blinded to group allocation. Methods section (page 101): "the physician was blinded to the treatment program". However, no safeguards were described and subjective outcomes reported by the patients were not blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Results section (page 102): "all patients completed the regular exercise program", therefore none appeared lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. However, all outcomes presented within the Results section (page 103) and Table 2, as previously discussed in the Methods section. |
Other bias | Low risk | No other potential bias identified |