Prospective, randomized, 3-way cross-over study 4-weeks treatment with each therapy
12 week
18–75 years Chronic LBP for >6 months due to disc prolapse, lumbar spondylosis, and/or spinal stenosis Minimum VAS >40 mm (on a scale of 0–100 mm) Patients with neurological disease excluded
Mixed
Celecoxib 3–6 mg/kg/die + placebo and Pregabalin 1 mg/kg/die for the first week, then 2–4 mg/kg/die + placebo and Celecoxib 3–6 mg/kg/die + pregabalin 1 mg/kg/die for the first week, then 2–4 mg/kg/die
Combination therapy was more effective than either monotherapy for mean pain reduction (assessing using 0–100 mm VAS)
Chronic LBP (46 months) Moderate to severe (>3 on a 0–10 VAS) Pain not responsive to previous systemic or local analgesic treatment
Osteoarticular, nociceptive pain (Group A) or neuropathic pain (Group B)
Group A Previous treatment discontinued: Oxycodone 5 mg + paracetamol 325 mg/8 hours Group B Previous treatment (except gabapentin). Fixed combination of oxycodone 5mg + paracetamol 325 mg/8 hours
Group A 73.9% and 78.3% (assessed using 0–10 VAS), respectively Group B All patients reported improved or stable neuropathic pain symptoms except pain preventing sleep
Significant reductions in pain(assessed using 0–100 VAS) were observed after month 1 Significant reductions in painafter month 2 were only observed in the combination group
18–65 years Lumbar radiculopathy Average leg pain score >4 (0–10 cm VAS) Patients with polyneuropathy and peripheral vascular disease associated with symptoms of numbness, or patients with burning painin the lower extremities, were excluded
Neuropathic
Morphine 15–90 mg and Nortriptyline 25–100 mg and Morphine 15–90 mg nortriptyline 25–100 mg
No significant reductions in mean leg pain (assessed using 0–10 VAS) or other leg or back pain were observed in any treatment group Pain reduction relative to placebo was 14% for nortriptyline, 7% for morphine, and 7% for combination therapy
21-day washout period, 91-day double-blind treatment period
> 18 years Chronic LBP Pain intensity >40 (0–100 mm VAS) Patients with neurologic deficits in lower extremities, symptomatic disk herniation, severe spinal stenosis, or spondy lolisthesis excluded
Nociceptive
Tramadol 37.5–300 mg + paracetamol 325–2600 mg or Placebo
Mean final pain intensity scores (assessed using 0–100 mm VAS) were significantly lower with combination therapy (47.4) than with placebo (62.9; ), as were mean final pain relief scores (assessed on 6-point Likertscale: 1.8 and 0.7, resp., )
