Table 2 Characteristics and risk of bias assessment of included trials

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