Table 1 Summary of trials.
| Â | Hoehler 1981 [42] | Gibson 1985 [43] | Cleary 1994 [47] |
|---|---|---|---|
Years conducted | 1973–1979 | ... | 1991–1992 |
Country | United States | United Kingdom | United Kingdom |
Setting | University clinic | Hospital outpatient clinic | Ambulatory clinic |
No. of subjects randomized | 95 | 109 | 30* |
Comparison | OMT vs soft tissue massage and sham manipulation | OMT vs short-wave diathermy OMT vs detuned short-wave diathermy | OMT vs sham manipulation |
Subject characteristics | |||
   Age, y |  |  |  |
Mean ± SD | OMT, 30.1 ± 8.4 Controls, 32.1 ± 9.8 | OMT, 34 ± 14 Short-wave diarthermy controls, 35 ± 16 Detuned short-wave diathermy controls, 40 ± 16 | Overall age range, 50–60 |
   Sex |  |  |  |
% male | OMT, 59 Controls, 59 | OMT, 49 Detuned short-wave diathermy controls, 68 Short-wave diarthermy controls, 53 | OMT, 0 Controls, 0 |
   Type of low back pain | Referred patients with acute or chronic low back pain | Referred patients with low back pain of greater than 2 months' and less than 12 months' duration | Recruited subjects with chronic low back pain in conjunction with menopausal symptoms |
OMT protocol | |||
   Technique | High-velocity, low-amplitude thrust only | Variety of techniques | Low-force techniques |
   No. of treatments |  |  |  |
Mean ± SD | OMT, 4.8 ± 2.7 Controls, 3.9 ± 2.5 | 4, per protocol | 10, per protocol |
Outcomes assessment | Blinded | Blinded | Assessment independent of treatment, blinding not specified |
No. of pain contrasts | 3 | 6 (3 for each of the two OMT vs control treatment comparisons) | 1 |
Type of pain outcome | Dichotomous pain outcomes | Dichotomous pain outcomes | Dichotomous pain outcome |
Timing of pain contrasts | Â | Â | Â |
   Short-term | First treatment and mean, 20–30 days following randomization | 2 and 4 weeks | ... |
   Intermediate-term | Mean, 41–51 days following randomization | ... | ... |
   Long-term | ... | 12 weeks | 15 weeks |
| Â | Andersson 1999 [44] | Burton 2000 [45] | Licciardone 2003 [46] |
Years conducted | 1992–1994 | ... | 2000–2001 |
Country | United States | United Kingdom | United States |
Setting | Health maintenance organization | Hospital orthopedic department | University clinic |
No. of subjects randomized | 178 | 40 | 91 |
Comparison | Usual care and OMT vs usual care only | OMT vs chemonucleolysis | Usual care and OMT vs usual care and sham manipulation Usual care and OMT vs usual care only |
Subject characteristics | Â | Â | Â |
   Age, y |  |  |  |
Mean ± SD | OMT, 28.5 ± 10.6 Controls, 37.0 ± 11.0 | Overall, 41.9 ± 10.6 | Usual care and OMT, 49 ± 12 Usual care and sham manipulation controls, 52 ± 12 Usual care only controls, 49 ± 12 |
   Sex |  |  |  |
% male | OMT, 41 Controls, 44 | Overall, 48 | Usual care and OMT, 31 Usual care and sham manipulation controls, 43 Usual care only controls, 35 |
   Type of low back pain | Patients with low back pain of 3 or more weeks' and less than 6 months' duration | Recruited patients with low back pain and sciatica; mean duration, 30 and 32 weeks in OMT and chemonucleolysis groups, respectively | Recruited subjects with low back pain of at least 3 months' duration |
OMT protocol | Â | Â | Â |
   Technique | Variety of techniques, individualized to patient | Variety of techniques, individualized to patient | Variety of techniques, individualized to subject |
   No. of treatments |  |  |  |
Mean ± SD | 8, per protocol | Mean for OMT, 11; range 6–18 | 7, per protocol |
Outcomes assessment | Blinded | Blinded | Blinded |
No. of pain contrasts | 1 | 3 | 6 (3 for each of the two OMT vs control treatment comparisons) |
Type of pain outcome | Pain scale | Pain scales | Pain scales |
Timing of pain contrasts | Â | Â | Â |
   Short-term | ... | 2 weeks | 1 month |
   Intermediate-term | 12 weeks | 6 weeks | 3 months |
   Long-term | ... | 12 months | 6 months |