| Methods |
Study design: RCT; Unit of allocation: Patients; Method of randomisation: block randomisation with a manual schedule; Allocation concealment: adequate; Blindedness: Double blind |
| Participants |
Randomized = 61; Analysed = 58
Recruitment of patients: referral from local physicians; Enrollment dates: Not stated; Age: Between the ages of 20 and 60 years; Sex: Male and female; Ethnicity: Not stated; Work status: Not stated; Diagnosis of LBP: pain in the lumbosacral area of the spine of more than 12 weeks' duration, may or may not have referred characteristics; Duration of pain: More than 12 weeks; Previous treatments: No limitations; Exclusion criteria: Patients with degenerative disc disease, disc herniation, fracture, spondylosis, and spinal stenosis, neurological deficits, abnormal laboratory findings, systemic or psychiatric illness, and pregnancy |
| Interventions |
Three arms of the study were included: LLLT+exercise(21), sham+exercise(20), and LLLT alone(20)
LLLT protocol: 12 sessions (i.e., twice a week for 6 weeks); Laser medium:Gallium‐Aluminum‐Arsenide (GaAlAs) laser; Laser model: not stated; Wave length(nm): 810 nm; Laser mode: continuous; Output power: 50 mW; Laser class: IIIb; Spot diameter(cm): 0.53 cm; Exposure time: 2 min for each point (totally 10 points); Anatomic locations: In each session, a series of standardised fields including eight points in the paravertebral region (L2 to S2‐S3) were irradiated by a single laser probe in contact mode; Sham laser: inactive laser probe.
Exercise protocol: The first exercise session was conducted by a physiotherapist and were continued at home, taught by the physiotherapist and confirmed by a family member. Exercises included strengthening, stretching, mobilising, co‐ordination, and stabilising of the abdominal, back, pelvic, and lower limb muscles, dependent on the clinical findings. |
| Outcomes |
Measurements by: A physicians blinded to group allocation; Measured variables: Pain(10‐cm visual analogue scale), lumbar range of motion(Schober Test), disability(10‐item Oswestry disability questionnaire); Follow up sessions: at Week 6 (after the last session of intervention) and at Week 12; Intention‐to‐treat analysis: yes |
| Notes |
Total score: 10 |
| 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? |
Low risk |
|
| Similarity of baseline characteristics? |
Low risk |
|
| Co‐interventions avoided or similar? |
Unclear risk |
Unclear from text |
| Compliance acceptable? |
Low risk |
|
| Timing outcome assessments similar? |
Low risk |
|
