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. 2023 Aug 30;2023(8):CD009365. doi: 10.1002/14651858.CD009365.pub2

Aluko 2013.

Study characteristics
Methods Study design: RCT
Recruitment period: July 2008–June 2010
Recruitment mode: participants were recruited from within a primary care musculoskeletal physiotherapy service provider within the London borough of Hillingdon. This unit provided a central base of treatment for people across the borough who were referred by their GP.
Statistical analysis: outcome data analysed using multiple regression analysis where the baseline value was included as a covariate for each analysis. All data were skewed and log‐transformed, results are presented as the ratio geometric means with 95% CI. An ITT analysis was used with missing data replaced with the LOCF for incomplete data sets.
Sample size calculation: in the absence of a known published clinically significant difference for the major outcome measure of mean trunk sagittal acceleration resulting from CSEs, it was not possible to use a standardised calculation to determine the appropriate sample size. The sample size was therefore derived from a similar study previously published.
Participants Sample size: total: 33; EG1: 16; EG2: 17
Setting: primary care musculoskeletal physiotherapy service provider
Country: UK
Baseline characteristics
  • Age in years, mean (SD): EG1: 36.2 (9.8); EG2: 35.8 (9.1)

  • Sex, number (%) women: EG1: 13 women (81%); EG2: 15 women (88%)


Duration LBP: ≤ 6 weeks; 22 (67%) of participants had a previous episode of acute NSLBP
Inclusion criteria
  • Onset of acute NSLBP with maximum duration of 6 weeks


Exclusion criteria
  • Degenerative conditions affecting the spine, diabetes, pregnancy, underlying neurologic conditions, active treatment of an ongoing spinal condition

  • Active legal/compensation procedures

  • History of depression

  • History of multiple recurrent episodes of LBP

  • Involvement in other research studies

  • Not having English as primary language

Interventions EG1: core stability class + stabilisation exercises
  • Description: a core stability class consisting of both specific and global trunk exercises. Further instruction on 8 specific stabilisation muscles involving the transversus abdominis (TrA) and the lumbar multifidus (LM), abdominal hollowing while lying prone, alternate straight‐leg raise in supine, abdominal hollowing in sitting, Crook lying–alternate heel slide, 4‐point kneeling pelvic shift (side to side), trunk curl in crook lying, pelvic tilt in sitting, and alternate knee raise in sitting. 10 repetitions, 3 times/day.

  • Materials/equipment: no

  • Non‐exercise component: not reported

  • Frequency and duration: 10 repetitions, 3 times/day for 6 weeks

  • Delivery: supervised generic group lesson and unsupervised home programme

  • Provider: PT


EG2: core stability class
  • Description: core stability class consisting of both specific and global trunk exercises

  • Materials/equipment: no

  • Non‐exercise component: not reported

  • Frequency and duration: 3 times/day for 6 weeks

  • Delivery: supervised generic group lesson and unsupervised home programme

  • Provider: PT

Outcomes Note: outcomes not designated as major or minor outcomes
Pain: VAS (0–100)
  • Baseline, mean (SD): EG1: 36.4 (23.2); EG2: 31.4 (22.0)

  • 6 weeks, mean (SD): EG1: 31.8 (23.6); EG2: 26.7 (26.0)

  • 3 months, mean (SD): EG1: 25.9 (23.2) EG2: 27.1 (26.7)


Functional status: RMDQ
  • Baseline, mean (SD): EG1: 8.6 (5.0); EG2: 10.5 (5.0)

  • 6 weeks, mean (SD): EG1: 7.4 (5.4); EG2: 9.4 (5.8)

  • 3 months, mean (SD): EG1: 6.8 (5.1); EG2: 8.4 (6.0)


Other: trunk sagittal acceleration
Adverse events: not reported
Notes Authors' results and conclusions: the difference in pain and disability between the groups was statistically and clinically nonsignificant
Funding: no funding sources reported
Declaration of interest: no conflicts of interest reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The participants were randomly allocated"; "The randomisation was done by a colleague independent and blind to the study using concealed envelopes within which the group description was randomly placed within them."
Allocation concealment (selection bias) Low risk Quote: "The randomisation was done by a colleague independent and blind to the study using concealed envelopes."
Blinding
All outcomes ‐ Participants High risk No mention of attempts to blind participants or their perceptions of the potential effectiveness of the different interventions.
Blinding
All outcomes ‐ Healthcare providers High risk No mention of any attempts to blind care providers.
Blinding
All outcomes ‐ outcome assessors High risk The outcome measures were self‐reported and participants were unblinded.
Influence of co‐interventions Unclear risk Personal communication: participants were requested not to seek additional treatment and the treating physiotherapists did not offer additional treatment. However, the study did not record whether participants sought other therapies.
Group similarity at baseline Unclear risk Study measured age, sex, height, weight. There were no differences between groups. No other baseline measures were reported.
Compliance High risk Personal communication: compliance was acceptable compared to clinical practice: 7/16 participants did no exercises; 4 participants did exercises some days (6, 7, 17, or 23 days); 5 participants did exercises all or most days.
Timing of outcome assessments Low risk Measurements at 3 weeks, 6 weeks, and 3 months of follow‐up.
Incomplete outcome data (attrition bias)
Dropouts – all outcomes High risk Personal communication: flowchart with the number of dropouts: 11 in the exercise group, 11 in the control group.
Intention‐to‐treat‐analysis Low risk Quote: "An intention‐to‐treat analysis was used with missing data replaced with the Last Observation Carried Forward for incomplete data sets."
The number of dropouts does not differ between groups.
Selective reporting (reporting bias) Low risk Pain intensity and function reported; no published protocol available.
Other bias Unclear risk No funding sources were reported. No official disclosure regarding potential conflicts of interest.