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Table 2 Characteristics and risk of bias assessment of included trials

From: Osteopathic intervention in chronic non-specific low back pain: a systematic review

Author Licciardone, 2003[21] Chown et al., 2008[26]
Participants N=91, 21-69yo N=239, 18-65yo
Randomised Yes Yes
Blinding Patients Patients and Assessors
Inclusion NSLBP for 3 months NSLBP for 3 months
Exclusion Red flags, neurological signs, surgery, workers comp, pregnancy, recent manipulation Red flags, radiculopathy, surgery, anti-coagulants
Intervention detail Senior osteopathic students One osteopath
Choice of soft tissue, MET, Art, HVT, SCS, cranio-sacral, myofascial technique Choice of soft tissue, MET, Art, HVT, functional, exercise, education, psychosocial, nutritional advice
Seven sessions over 5 months Five sessions over 3 months
Follow up at 1, 3 and 6 months Follow up 6 weeks and 12 months
Control Sham or no treatment Manipulative PT or group exercise
Outcome measures SF-36, VAS, RM, ODI, satisfaction questionnaire ODI, EuroQoL, Shuttle walk test, satisfaction questionnaire
Main results SF-36: (For osteopathy only)
1 month OMT >control (p=0.03) ODI - 5.0 (95% CI 1.6 – 8.4; SD 10.5; p<0.01):
3 months Sham > OMT/control (p=0.01) EQ-5D 0.11 (CI 0.02 to 0.19; SD 0.24; p<0.05):
6 months Sham > OMT/control (p=0.03) Group comparison not done
VAS pain:
1 month OMT/Sham >control (p=0.01/0.003)
3 months OMT/Sham >control (p=0.001/0.001)
6 months OMT/Sham >control (p=0.02/0.02)
RM no differences
OMT less co-treatments (p=0.03)
Risk of Bias score /12 Detail of point loss 7 9
Randomisation process not fully described Patients not blinded
Care provider not blinded Care provider not blinded
Drop out rate not fully described Compliance not acceptable
Co-interventions not avoided
Compliance not acceptable
Quality Issues Confounders in sham techniques, co-treatments Sample size reduced
Statistical analysis incomplete