Taverna 1990.
Methods |
Design: Parallel group, two‐arm double‐blind randomised controlled trial (Italy) Interventions: Low‐level laser therapy (LLLT) or placebo laser therapy Sample size calculation: Not reported Analysis: Intention‐to‐treat analysis Source of funding: Not reported |
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Participants |
Number of participants: 40 (20 per group) Baseline characteristics: Age, sex and duration of symptoms not reported Inclusion criteria: 1. Diagnosed with scapulohumeral periarthritis Exclusion criteria: Not reported |
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Interventions |
Laser therapy (N=20) Components of intervention: Low‐level laser therapy (1000Hz, 24mW). Trialists irradiated painful points (where the pain occurs spontaneously and with a ratio more or less closely with the damaged structures), the points of greater access (points which may also not evoke a painful response, or even pressure, but where the emitted beam can penetrate better into the tissues and effectively reach treatment areas) and to a lesser extent the trigger points (points that, when excited, trigger pain in a target area that never corresponds to the trigger point) Dosage: 15 to 20 minutes Frequency of administration: Daily for six days Provider: Orthopaedic physician Placebo laser therapy (N=20) Participants received the same interventions as described above, except that placebo laser therapy was provided |
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Outcomes | Outcomes assessed at the end of six days treatment. No primary outcome was reported by the trialists 1. Patient‐reported improvement in pain and function, rated as "excellent result" = improvement of 80% or more; "good result" = improvement between 60% to 80%; "reasonable result" = improvement between 40% to 60%; or "insufficient result" = improvement less than 40% 2. Adverse events |
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Notes | Article is written in Italian. MP used Google Translate to translate into English. Quality of translation was good. There were 40 additional participants in this RCT who had cervical osteoarthritis (their data has not be included in this table). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "For each type of pathology we divided the patients, using the table of random numbers, into two groups: treated and untreated with IR laser..." (Google Translate translation of Italian article) Comment: An adequate method was used to generate the allocation sequence |
Allocation concealment (selection bias) | Unclear risk | Comment: No information on how the allocation sequence was concealed was reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "... and all were subjected to the same number of sessions and the same application diagrams with the apparatus of laser emission both cases "in function", with the same sounds (acoustic marks bearer of power is on) and bright light (pointing), a subgroup was actually treated while the other was used as a control being turned OFF prior to the application through the laser diode removed from the handpiece" (Google Translate translation of Italian article) Comment: Participants, but not personnel, were blind to treatment |
Blinding of outcome assessment (detection bias) Self‐reported outcomes | Low risk | Comment: Blinded participants self‐reported pain and function |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Quote: "The evaluation was conducted before treatment and at the end of the same, and the results were evaluated by one of A. not aware of the subgroup to which the patient belonged (treated or placebo)" (Google Translate translation of Italian article) Comment: Assessors of adverse events were probably blind to treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: No dropouts, losses to follow‐up or exclusions were reported, and outcome data was reported as being based on the number of randomised participants |
Selective reporting (reporting bias) | Unclear risk | Comment: Outcome data was fully reported for all outcomes specified in the methods section of the publication, but without a trial protocol it is unclear whether other outcomes were measured but not reported based on the results |
Other bias | Low risk | Comment: No other sources of bias identified |