Toya 1994.
| Methods | Study design: RCT; Unit of allocation: Patients; Method of randomisation: a computer generated schedule; Allocation concealment: adequate; Blindedness: Double‐blinded | |
| Participants | randomised = 130; analysed 115, 41 of whom had LBP and were included in this review Recruitment of patients: patients attending their respective institution on an outpatient basis; Enrollment dates: Not stated; between the ages of 18 to 82 y; Sex: Male and female; Ethnicity: Not stated; Work status: Not stated; Diagnosis of LBP: Not stated, Lumbar pain group(41 patients) consisted of Lumbago(23), Ischiatic neuralgia(9), Lumbar musculofascial pain(2), herniated disc(3), lumbar spondylosis(4); Duration of pain: not stated; Previous treatments: no limitations, a wash‐out period was done on any patient on medications; Exclusion criteria: not stated | |
| Interventions | Both arms of the trial were included: LLLT(16) and sham(25).
Intervention group: laser, single session, no other treatments allowed; Laser medium:Ga‐Al‐As diode laser ; Laser model: OhLase‐3D1(Proli, Japan); Wave length(nm): 830 nm; Laser mode: continuous; Output power: 60 mW; Laser class: Not stated; Spot diameter(cm): 0.16 cm; Exposure time(seconds): 5 to 10 min (mean of 9.18 min); Anatomic locations: On painful area Control group: Sham irradiation with a deactivated laser radiation, but the electrical circuit, timer and alarm worked as usual and controlled by a locked remote centralised computer |
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| Outcomes | Measurements by: a blinded therapist ; Measured variables: pain graded as exacerbation, little or no change, fair, good, excellent; Follow up sessions: immediately and one day after treatment; Intention‐to‐treat analysis: no | |
| Notes | Total score: 9 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | |
| Allocation concealment? | Low risk | A ‐ Adequate |
| Blinding? All outcomes ‐ patients? | Low risk | |
| Blinding? All outcomes ‐ providers? | Low risk | |
| Blinding? All outcomes ‐ outcome assessors? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | High risk | |
| Similarity of baseline characteristics? | Unclear risk | Unclear from text |
| Co‐interventions avoided or similar? | Low risk | |
| Compliance acceptable? | Low risk | |
| Timing outcome assessments similar? | Low risk | |