Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial

Kim, Ho-Joong; Kim, Jin Hyok; Park, Ye Soo; Suk, Kyung Soo; Lee, Jae Hyup; Park, Moon Soo; Moon, Seong Hwan

doi:10.1016/j.spinee.2016.02.049

Cited by 29 publications

(66 citation statements)

References 32 publications

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“…In previous studies, the noninferiority margin of the ODI has been set at the same value as the minimal important change value, 11,12 which was proposed to be 10 points for the ODI and 2 points for the NRS. 13 However, a noninferiority margin of 10 points for the ODI appeared to be generous.…”

Section: Methodsmentioning

confidence: 99%

Expansive Suspension Laminoplasty Using a Spinous Process–Splitting Approach for Lumbar Spinal Stenosis: Surgical Technique and Outcomes Over 8 Years of Follow-up

Kakiuchi¹,

Wada

Harada

et al. 2018

JAAOS Glob Res Rev

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Introduction:To maximize the benefits of posterior decompression for severe multilevel lumbar spinal stenosis, we refined the expansive laminoplasty technique using a spinous process–splitting approach. This study tests the hypothesis that the surgical benefit of adequate decompression with posterior element preservation is maintained in the long term, over 8 years of follow-up.Methods:Fifty-eight patients were followed up yearly for 8 years. Eight patients having nonlumbar spine surgery or Parkinson disease were excluded. The noninferiority of the 8-year versus peak-year outcomes was tested, with margins of 5 points for the Oswestry disability index and 1 point for the numeric rating scales (NRSs).Results:In the 50 patients available for follow-up, the peak values of the mean improvements from baseline within the first 7 years were 35.8, 5.7, 5.9, and 2.8 points for the Oswestry disability index, low back pain NRS, leg pain NRS, and leg numbness NRS, respectively. The 95% lower confidence limits for the differences between the mean improvements from baseline at 8 years and the peak year were within the noninferiority margins for each scale.Conclusion:Our technique was associated with substantial improvement from baseline for each scale. The initial improvements in function and symptoms were maintained for 8 years.

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Section: Methodsmentioning

confidence: 99%

Expansive Suspension Laminoplasty Using a Spinous Process–Splitting Approach for Lumbar Spinal Stenosis: Surgical Technique and Outcomes Over 8 Years of Follow-up

Kakiuchi¹,

Wada

Harada

et al. 2018

JAAOS Glob Res Rev

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“…Nonsurgical treatment is appropriate for patients with mild to moderate symptoms. Commonly used treatment strategies include bed rest for a short period of approximately 1 week, medication (anti-inflammatory drugs, oral adrenal corticosteroids, muscle relaxants, prostaglandin E1 analogs, antidepressants, and anticonvulsants such as gabapentin), lumbar exercise (isometric flexion exercise and hyperextension exercise), physical therapy, orthosis usage, thermal therapy, ultrasound, massage, electrical stimulation, and traction therapy [ 21 , 32 ].…”

Section: Nonoperative Treatmentmentioning

confidence: 99%

Lumbar Spinal Stenosis: Pathophysiology and Treatment Principle: A Narrative Review

et al. 2020

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Patients with lumbar spinal stenosis may exhibit symptoms such as back pain, radiating pain, and neurogenic claudication. Although long-term outcome of treatments manifests similar results for both nonsurgical and surgical treatments, positive effects such as short-term improvement in symptoms and decreased fall risk may be expected with surgery. Surgical treatment is basically decompression, and a combination of treatments can be added depending on the degree of decompression and the accompanying instability. Recently, minimally invasive surgery has been found to result in excellent outcomes in the treatment of lumbar spinal stenosis. Therefore, better treatment effects can be anticipated with an approach aimed at understanding the overall pathophysiology and treatment methods of lumbar spinal stenosis.

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“…However the superiority of pregabalin did not last throughout all observational period. A recent double -blind, randomized study showed that the efficacy of limaprost for LSS -induced leg pain was similar to that of pregabalin at time points of 4 and 8 weeks with an improvement from baseline over time 22) . That temporal superiority for pregabalin in the current study implies the possibility of a gradual analgesic effect of limaprost or just mirroring natural history of CSR with the treatment of NSAIDs ; however, the exact explanation is beyond the obtained results.…”

Section: Discussionmentioning

confidence: 94%

“…Clinical studies reported that oral administration of PGE 1 , limaprost, improved neurological symptoms, walking ability, and quality of life (QOL) in patients with lumbar spinal stenosis (LSS) 19 -21) . In addition, a recent randomized controlled trial showed that limaprost was not inferior to pregabalin in LSS 22) . These findings lead us to propose a therapeutic potential of limaprost for CSR, taking into account the similar neural pathogenesis caused by nerve root compression.…”

Section: Introductionmentioning

confidence: 99%

Comparisons between the efficacy of limaprost alfadex and pregabalin in cervical spondylotic radiculopathy : design of a randomized controlled trial

Onda

Kimura

2018

FJMS

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Background : Cervical spondylotic radiculopathy (CSR) is a relatively common neurological disease caused by the mechanical compression of nerve roots. Limaprost, a prostaglandin E 1 derivative, functions as a vasodilator and has been used in the treatment of lumbar spinal stenosis in Japan. However, the effects of limaprost in cervical radiculopathy remain unclear. Our aim was to compare the efficacy of limaprost with that of pregabalin, which is widely used for the treatment of neuropathic pain. Methods : In this randomized trial, patients with CSR received either limaprost or pregabalin orally for 8 weeks, along with nonsteroidal anti -inflammatory drugs. The primary outcomes were assessed using a numerical rating scale of pain and numbness, both at rest and during movement. Secondary outcomes were assessed using Short Form -36, provocation tests, painDETECT questionnaire, and subjective global assessment. The obtained data were evaluated according to the per -protocol analysis principle. Results : A total of 46 patients were enrolled in this study, and 35 were available for analysis. A greater reduction in pain score was observed in neck pain during movement, and scapular and arm pain both at rest and during movement in the pregabalin -treated group up to 4 weeks. In the limaprost -treated group, numbness of the arm during movement showed a marked alleviation compared to the pregabalin -treated group at 8 weeks. There were no apparent differences between the two groups in terms of the secondary outcomes. Conclusions : Although pregabalin provided an earlier pain relief than limaprost, limaprost was superior to pregabalin in treating arm numbness. Limaprost might be one of the effective therapeutic options for CSR in primary care settings.

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Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial

Cited by 29 publications

References 32 publications

Expansive Suspension Laminoplasty Using a Spinous Process–Splitting Approach for Lumbar Spinal Stenosis: Surgical Technique and Outcomes Over 8 Years of Follow-up

Expansive Suspension Laminoplasty Using a Spinous Process–Splitting Approach for Lumbar Spinal Stenosis: Surgical Technique and Outcomes Over 8 Years of Follow-up

Lumbar Spinal Stenosis: Pathophysiology and Treatment Principle: A Narrative Review

Comparisons between the efficacy of limaprost alfadex and pregabalin in cervical spondylotic radiculopathy : design of a randomized controlled trial

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