Participants
|
N=91, 21-69yo
|
N=239, 18-65yo
|
Randomised
|
Yes
|
Yes
|
Blinding
|
Patients
|
Patients and Assessors
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Inclusion
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NSLBP for 3 months
|
NSLBP for 3 months
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Exclusion
|
Red flags, neurological signs, surgery, workers comp, pregnancy, recent manipulation
|
Red flags, radiculopathy, surgery, anti-coagulants
|
Intervention detail
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Senior osteopathic students
|
One osteopath
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Choice of soft tissue, MET, Art, HVT, SCS, cranio-sacral, myofascial technique
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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
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Sham or no treatment
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Manipulative PT or group exercise
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Outcome measures
|
SF-36, VAS, RM, ODI, satisfaction questionnaire
|
ODI, EuroQoL, Shuttle walk test, satisfaction questionnaire
|
Main results
|
SF-36:
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(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 |