Table 3 Overview of included randomised clinical trials of osteopathic manipulative treatment for low back pain

Aim of the study

Can OMT provide a specified effect on the functional impairment and pain of patients with chronic lumbar back pain?

Comparison of OMT with standard care for patients with low back pain.

Is one to one physiotherapy or physiotherapy-led group exercise as effective as one to one osteopathy for patients with chronic low back pain?

Examination of efficacy of OMT in relieving acute low back pain and improving functioning in military personnel.

Comparison of OMT with SWD and placebo SWD in nonspecific low back pain.

Duration of pain

At least 6 months

At least 3 weeks, but less than 6 months

More than 3 months

Acute = minimum of 30 days hiatus of pain from previous LBP episodes

At least 2 months, but less than 12 months

Reported inclusion/exclusion criteria

Yes/Yes

Yes/Yes

Yes/Yes

Yes/Yes

Yes/Yes

Outcome Measurement

1. Roland Morris life quality score, 2. VAS, 3. SF-36 (modified), 4. Side effects

1. VAS, 2. RMDQ, 3. OPQ, 4. ROM, 5. Straight-leg raising

1. ODI, 2. EuroQol EQ-5D, 3. VAS, 4. Shuttle walk test

1. QVAS, 2. RMDQ, 3. SF-36, 4. Patient expectation questionnaire

1. VAS (daytime and nocturnal scores), 2. Spinal flexion, 3. Return to work, 4. Recovery, 5. Analgesic consumption

No. of patients/dropouts

57/10

178/23

239/85⁴

60/3

109/4¹/ 5²/12³

No. of patients/mean age

a. Intervention

a = 29/40.4 years

a = 83/28.5 years

a = 79/43.5 years

a = 30/26.3 years

a = 41/34 years

b. Control

b = 28/41.8 years

b = 72/37.0 years

b = 80/44.3 years

b = 30/27.1 years

b = 34/35 years

c. Control

c = 80/42.5 years

c = 34/40 years

Treatment (No.)

a. Intervention

a = OMT (5)

a = OMT (8)

a = OMT (5)

a = OMT (4) + usual care

a = OMT (4)

b. Control

b = Sham treatment (5)

b = Standard medical therapies (8)

b = Physiotherapy (5)

b = Usual care

b = SWD (12)

c. Control

c = Group exercise (5)

c = Placebo SWD (12)

Period

60 days

12 weeks

3 months

4 weeks

4 weeks

Authors’ conclusion

‘OMT – in comparison to the sham treatment - shows statistically significant and clinically important improvements regarding primary and secondary outcome measures.’

‘Osteopathic manual care and standard medical care have similar clinical results in patients with subacute low back pain. However, the use of medication is greater with standard care.’

‘All three treatments indicated comparable reductions in mean (95% CI) ODI at 6-week follow-up....One-to-one therapies provided evidence of greater patient satisfaction.’

‘The study supports the effectiveness of OMT in reducing acute LBP pain in active duty military personnel.’

‘These observations indicate that neither osteopathic manipulation nor SWD was superior to placebo treatment.’

Author/Year

Gundermann 2013

Heinze 2006

Licciardone 2003

Licciardone 2009

Licciardone 2013

Country

Germany

Germany

United States

United States

United States

Aim of the study

To evaluate the effectiveness of osteopathic treatment in pregnant women suffering from LBP.

Determination of the efficacy of OMT applied to subacute lumbar back pain.

Determination of the efficacy of OMT as a complementary treatment for chronic nonspecific LBP.

Examination of OMT for back pain and related symptoms during the third trimester of pregnancy.

To study the efficacy of OMT and UST for chronic low back pain.

Duration of pain

At least 1 week

Between 4 weeks and 6 months

At least 3 months

Not specified

At least 3 months

Reported inclusion/exclusion criteria

Yes/Yes

Yes/Yes

Yes/Yes

Yes/Yes

Yes/Yes

Outcome Measurement

1. VAS, 2.Frequency of pain, 3. RMDQ, 4. Questionnaire (postpartum).

1. NRS for current and average level of pain, 2. RMDQ

1. SF-36, 2. VAS, 3. RMDQ, 4. Work disability, 5.Satisfaction with back care

1. Back pain on an 11-point scale, analysed like a 10-cm VAS for pain, 2. RMDC

1. VAS, 2. RMDQ, 3. SF-36 general health score, 4. Lost work days, 5.Satisfaction with back care, 5. Co-treatments.

No. of patients/ Dropouts

41/2

60/2

91/25

146/2 (Prior first visit)

455/93

No. of patients/mean age

a. Intervention

a = 21/29 years

a = 28/42.1 years

a = 48/49 years

a = 49/23.8 years

a = 230/41 (median) years

b. Control

b = 20/31 years

b = 32/44.3 years

b = 23/52 years

b = 48/23.7 years

b = 225/40

c. Control

c = 20/49 years

c = 49/23.8 years

(median) years

Treatment (No.)

a. Intervention

a = OMT (4)

a = OMT (2–3) + heat & PT (6)

a = OMT (7) + UC

a = UOBC + OMT (7)

a = OMT ⁵ (6)

b. Control

b = Untreated

b = Heat & PT (6)

b = Sham manipulation (7) + UC

b = UOBC + SUT (7)

b = Sham OMT ⁵ (6)

c. Control/Period

c = UC

c = UOBC

7 weeks

6 weeks

5 months

10 weeks

8 weeks

Authors’ conclusion

‘Four osteopathic treatments over a period of 8 weeks led to statistically significant and clinically relevant positive changes of pain intensity and frequency in pregnant women suffering from low back pain.’

‘In the area of pain, as well as in the area of the disabilities a clinically relevant improvement could be achieved.’

OMT and sham manipulation ‘both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain’.

‘Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy’.

‘The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.’

Author/Year

Mandara 2008

Peters 2006

Recknagel 2007

Schwerla 2012

Vismara 2012

Country

Italy

Germany

Germany

Germany

Italy

Aim of the study

To compare the effects of OMT with sham manipulative treatment (SMT) on patient’s self-reported pain and disability.

Assessment whether OMT influences the pain-symptomatology of women with pregnancy related low back pain.

Investigation whether OMT had an effect on women with post-partum persistent unspecific backache.

To evaluate the effectiveness of osteopathic treatment in women suffering from persistent low back pain after childbirth.

Is OMT combined with specific exercises more effective than specific exercises alone in obese female patients with chronic low back pain?

Duration of pain

More than 3 month

At least 1 week

At least 3 months, not more than 24 months

After childbirth for at least 3 months and at most 20 months

More than 6 months

Reported inclusion/exclusion criteria

No/No

Yes/Yes

Yes/Yes

Yes/Yes

Yes/Yes

Outcome Measurement

1. VAS, 2. ODI

1. VAS, 2. Quebec Back Pain disability scale

1. VAS, 2. OPQ, 3. Regions of dysfunction

1. VAS, 2. OPQ. 3. Different specific health problems

1. Kinematic of thoracic/ lumbar spine/pelvis during forward flexion, 2. VAS, 3. RMDQ, 4. LBP-DQ

No. of patients/Dropouts

94/6

60/3

40/1

80/3

21/2

No. of patients/mean age

a. Intervention

a = 44/NS

a = 30/30.6 years

a = 20/34.5 years

a = 39/33.9 years

a = 8/42.0 years

b. Control

b = 50/NS

b = 30/30.2 years

b = 19/34.4 years

b = 40/33.3 years

b = 11/44.7 years

c. Control

Treatment (No.)

a. Intervention

a = OMT + Usual care (6)

a = OMT (4)

a = OMT (4)

a = OMT (4)

a = OMT (1) + SE (10)

b. Control

b = SMT + Usual care (6)

b = No treatment

b = No treatment

b = Untreated

b = SE (10)

c. Control/Period

6 weeks

4 weeks

8 weeks

8 weeks

NS

Authors’ conclusion

‘…OMT appears to provide benefits over and above usual care for the treatment of CLBP. The improvement in the OMT compared to the SMT demonstrated that placebo effects… do not justify per se the results of this study.’

‘Four osteopathic treatments… could cause a clinically relevant influence on the pain-symptomatology and on the interference of daily life of pregnant women with pain in the pelvic and/or lumbar area’.

OMT ‘for women with persistent, unspecific backache post-partum brings about a clinically relevant improvement of the pain symptoms and a reduction of the impediment on daily life’.

‘Four osteopathic treatments over a period of eight weeks led to statistically significant and clinically relevant positive changes of pain intensity and effects of low back pain on everyday activities in women suffering from low back pain after childbirth’

‘OMT + SE showed to be effective in improving biomechanical parameters of the thoracic spine in obese patients with chronic LBP …’