Glaviano 2016.
Methods | Double‐blinded, randomised sham‐controlled trial Trial protocol registration: not reported |
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Participants |
Country: United States Setting: laboratory (single NMES session) Data collection period: not described Inclusion criteria: age between 15 and 65, atraumatic knee pain (greater than 3 months), pain with more than 2 of the following activities: jumping, kneeling, prolonged sitting, quadriceps contraction, running, squatting, or stair climbing or when pressure was placed on the patella. Participants were required to score less than 85 of 100 on the Anterior Knee Pain Scale. Exclusion criteria: previous knee surgery, ligamentous instability, meniscal injury, or other sources of anterior knee pain, such as patellar tendinitis, bursitis, or patella subluxation. Contraindications to electrical stimulation: implanted biomedical devices, history of neuropathy, muscular abnormality, hypersensitivity to electrical stimulation, or active infection where the electrodes would be placed. Mean duration of symptoms: not reported People who presented bilateral complaints were included, but only the most symptomatic knee was treated. Study participants: 22 people with patellofemoral pain assigned and assessed
Mean age (SD): 26.0 (7.9) years Gender (number of women/men): 15/7 |
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Interventions |
Comparison: NMES versus placebo Treatment duration: single session (15‐minute treatment) Treatment setting: laboratory Details of interventions:
At the end of the intervention, the PENS electrodes were removed, and the participants were instructed to perform 2 functional movements. Outcome data were collected for both tasks.
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Outcomes |
Outcomes analysed in the study and used in this review:
Follow‐up assessments: immediately at the end of the single‐session treatment (after completing the single‐leg squat and lateral step‐down) |
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Notes | Description of condition: patellofemoral pain The trial authors provided additional information on random sequence generation, allocation concealment, and blinding (participants, personnel, and assessors) via email (12 August 2016). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Available information did not permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Quote: "One researcher concealed treatment interventions in envelopes, which were randomly allocated to participants before enrolment." The authors did not mention if the envelopes were sealed and opaque. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "sham controlled laboratory study" Since the authors did not exclude people who had received previous NMES therapy, it is difficult to affirm that the blinding was effective. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "At the conclusion of the 15‐minute treatment, electrodes were removed, the blinded researcher left the laboratory, and the primary researcher returned to the laboratory to conduct post‐intervention assessments" It is not clear if the outcome assessor was blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the study. |
Selective reporting (reporting bias) | High risk | No study protocol available. It is unclear if the results included all expected outcomes. This study did not consider adverse event as an outcome. Another report of this study that included a subgroup of 15 females presented the same baseline characteristics (age, height, mass, anterior knee pain score, and VAS pain knee) as those for the 22 participants in the study. |
Other bias | Unclear risk | Although the baseline characteristics were balanced between groups, we are uncertain whether these are correct. The pain scores (1.9 in both groups) were below the threshold ("more than 2") for inclusion in the trial. |