Miller 1997.
Methods | Prospective, single‐centre, non‐blinded, randomised controlled trial | |
Participants | Based in USA. No recruitment/study dates documented. 59 participants (data for 51: 13 females, 38 males). All participants were military cadets. Unclear who diagnosed and determined eligibility. Three groups: Palumbo sleeve group: n = 18 (3 female, 15 male; age not reported; duration of symptoms within 3 weeks of starting training) Cho‐Pat knee strap group: n = 13 (2 female, 11 male; age not reported; duration of symptoms within 3 weeks of starting training) Control group: n = 20 (8 female, 12 male; age not reported; duration of symptoms within 3 weeks of starting training) No further information on baseline characteristics available Inclusion criteria: Complaint of anterior knee pain within first three weeks of military training Exclusion criteria: Lack of desire to remain in basic training; previous surgery; history patellar dislocation; previously known knee disorders; abnormalities on physical examination; abnormal radiographs |
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Interventions |
Palumbo sleeve group: Participants received all interventions provided in the control group in addition to the provision, fitting and instruction to wear the Palumbo Brace throughout all military training activities Cho‐Pat knee strap group: Participants received all interventions provided in the control group in addition to the provision, fitting and instruction to wear the Cho‐Pat Knee Strap throughout all military training activities 'Brace wear was monitored throughout the study to ensure compliance." (p11 of article) Control group: Enrolled in physical therapy consisting of an exercise programme of closed‐chain quadriceps strengthening exercises and a lower limb tissue flexibility (stretching) programme; ibuprofen prescribed (800 milligrams) 3 times daily; and completion of basic military physical training. The trainees were allowed to substantially modify their activities at the risk of being 'disenrolled' from their 2 months training. |
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Outcomes | Participants were evaluated weekly from baseline to 8 weeks post‐randomisation. The main outcome assessed was the Patient Pain Profile Questionnaire, which incorporates a VAS score, a measure of participant's desire to remain in training and a measure of their desire to remain in training if their knee pain resolves. |
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Notes | The total number of recruits able to complete the training was also documented and the relevant reasons for attrition explained | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not clearly documented. Materials and Methods (page 11): participants “were then randomised into the groups”. |
Allocation concealment (selection bias) | Unclear risk | No clear documentation as to whether randomisation was performed through a concealed method. Materials and Methods (page 11): participants “were then randomised into the groups”. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No information was provided regarding whether participants or study personnel/clinicians were blinded to group allocation. Due to the nature of the intervention, it would have been logistically difficult to blind participants to the bracing interventions. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The paper did not detail whether assessors were blinded to group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Participant attrition was documented with all participants accounted for. Materials and methods page 12: "four participants were excluded from the study due to insufficient follow‐up. Four additional patients failed to complete basic training leaving 51 patients in the study cohort". While the % losses were similar in the three groups (13% to 14%), some bias could result from differing reasons for missing data. |
Selective reporting (reporting bias) | High risk | The Materials and Methods section states a number of outcome measurements were collected (Page 11). These included: "thigh circumference, effusion, popliteal angle, compression test, localised tenderness, apprehension test, Q‐Angle, range of motion, Lachmann test, anterior drawer, varus/valgus instability and McMurray’s tests.” However, these were not reported. The paper also only reported findings from the initial 3‐week follow‐up period, neglecting to provide data from weeks 4 to 8. No explanation was provided for this discrepancy in reporting. |
Other bias | Unclear risk | Baseline characteristics not provided for all randomised participants. |