pregabalin and Low-Back-Pain

Chronic low back pain (CLBP) is a global health problem, and gabapentin and pregabalin are often used in the treatment of patients without associated radiculopathy or neuropathy. Therefore, determining their efficacy and safety is of enormous value.. To examine the efficacy and safety of using gabapentin and pregabalin for CLBP without radiculopathy or neuropathy.. We performed a search on the CENTRAL, MEDLINE, EMBASE, LILACS, and Web of Science data bases for clinical trials, cohorts, and case-control studies that evaluated patients with CLBP without radiculopathy or neuropathy for at least eight weeks. The data were extracted and inserted into a previously-prepared Microsoft Excel spreadsheet; the outcomes were evaluated using the Cochrane RoB 2 tool, and the quality of evidence, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.. Of the 2,230 articles identified, only 5 were included, totaling 242 participants. In them, pregabalin was slightly less efficacious than amitriptyline, the combination of tramadol/acetaminophen, and celecoxib, and pregabalin added to celecoxib showed no benefit when compared to celecoxib alone (very low evidence for all). On the other hand, although one study with gabapentin did not support its use in a general sample of patients with low back pain, another found a reduction in the pain scale and improved mobility (moderate evidence). No serious adverse events were observed in any of the studies.. Quality information to support the use of pregabalin or gabapentin in the treatment of CLBP without radiculopathy or neuropathy is lacking, although results may suggest gabapentin as a viable option. More data is needed to fill this current gap in knowledge.. Dor lombar crônica (DLC) é um problema de saúde global, e a gabapentina e a pregabalina são frequentemente utilizadas no tratamento de pacientes sem radiculopatia ou neuropatia associada. Por isso, determinar sua eficácia e segurança é de enorme valor.. Examinar a eficácia e segurança do uso de gabapentina e pregabalina no tratamento da DLC sem radiculopatia ou neuropatia. MéTODOS:  Realizamos uma pesquisa nas bases de dados CENTRAL, MEDLINE, EMBASE, LILACS e Web of Science por ensaios clínicos, coortes e estudos de caso e controle que avaliassem pacientes com DLC sem radiculopatia ou neuropatia por pelo menos oito semanas. Os dados foram extraídos e inseridos em uma planilha previamente elaborada no programa Microsoft Excel; os desfechos foram avaliados com a ferramenta RoB 2 tool da Cochrane, e a qualidade das evidências, pelo sistema Grading of Recommendations Assessment, Development and Evaluation (GRADE).. Dos 2.230 artigos identificados, apenas 5 foram incluídos, com um total de 242 participantes. Neles, a pregabalina foi ligeiramente menos eficaz do que a amitriptilina, a combinação de tramadol/acetaminofeno, e o celecoxibe, assim como a pregabalina adicionada ao celecoxibe não mostrou benefício em comparação ao uso isolado de celecoxibe (evidência muito baixa para todos). Quanto à gabapentina, embora um estudo não respalde seu uso para uma amostra geral de pacientes com lombalgia, outro encontrou redução na escala de dor e melhora da mobilidade (evidência moderada). Nenhum evento adverso grave foi observado nos estudos. CONCLUSãO:  Há carência de informações de qualidade que sustentem o uso de pregabalina ou gabapentina no tratamento da DLC sem radiculopatia ou neuropatia, embora resultados possam sugerir que a gabapentina é uma opção viável. Mais dados são necessários para preencher essa atual lacuna no conhecimento.

Topics: Celecoxib; Gabapentin; Humans; Low Back Pain; Pregabalin; Radiculopathy

This SR aims to assess the effectiveness of pregabalin and gabapentin on pain and disability caused by acute sciatica and the adverse events associated with their clinical use.. Systematic review.. Electronic databases of Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and Clinical Trials.gov were searched from their inception until March 1st of 2021.. Randomized trials (RCT) with adults>18 years old with acute sciatica for a minimum of 1 week and a maximum of 1 year (at least moderate pain).. The outcomes were pain, disability and adverse events. Data was summarized using odds ratio and mean difference. GRADE was used to calculate the level of evidence.. Eight RCT involving 747 participants were included. The effect of pregabalin was assessed in 3 RCT and in one three-arm trial (pregabalin vs limaprost vs a combination of limaprost and pregabalin). Two trials assessed the effect of gabapentin compared with placebo and one compared with tramadol. One study assessed the effect of gabapentin vs pregabalin in a crossover head-to-head trial. A statistically significant improvement on leg pain at 2 weeks and leg pain with movement at 3 and 4 months was found in a RCT comparing gabapentin with placebo. There were no statistically differences on the remaining time periods assessed for leg pain, low back pain and functional disability.. This SR provides clear evidence for lack of effectiveness of pregabalin and gabapentin for sciatica pain management. In view of this, its routine clinical use cannot be supported.

Topics: Adolescent; Adult; Analgesics; Gabapentin; Humans; Low Back Pain; Pregabalin; Sciatica

The gabapentinoid drugs gabapentin and pregabalin were originally developed as antiseizure drugs but now are prescribed mainly for treatment of pain. For gabapentin, the only pain-related indication approved by the US Food and Drug Administration (FDA) is postherpetic neuralgia. For pregabalin, FDA-approved indications related to pain are limited to postherpetic neuralgia, neuropathic pain associated with diabetic neuropathy or spinal cord injury, and fibromyalgia. Despite these limited indications, gabapentin and pregabalin are widely prescribed off-label for various other pain syndromes. Such use is growing, possibly because clinicians are searching increasingly for alternatives to opioids.. This report summarizes the limited published evidence to support off-label gabapentinoid uses, describes clinical cases in which off-label use is problematic, and notes how review articles and guidelines tend to overstate gabapentinoid effectiveness.. Clinicians who prescribe gabapentinoids off-label for pain should be aware of the limited evidence and should acknowledge to patients that potential benefits are uncertain for most off-label uses.

Topics: Analgesics; Diabetic Neuropathies; Drug Approval; Fibromyalgia; Gabapentin; Humans; Low Back Pain; Minimal Clinically Important Difference; Neuralgia; Neuralgia, Postherpetic; Off-Label Use; Pain; Pain Measurement; Pregabalin; Radiculopathy; Sciatica; Spinal Cord Injuries

Chronic Low Back Pain (CLBP) is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG) and Gabapentin (GB) are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse. We aimed to assess the effectiveness and safety of gabapentinoids in adult CLBP patients.. Electronic databases of MEDLINE, EMBASE, and Cochrane were searched from their inception until December 20th, 2016. We included randomized control trials reporting the use of gabapentinoids for the treatment of CLBP of >3 months duration, in adult patients. Study selection and data extraction was performed independently by paired reviewers. Outcomes were guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief and safety as the primary outcomes. Meta-analyses were performed for outcomes reported in 3 or more studies. Outcomes were reported as mean differences (MDs) or risk ratios (RRs) with their corresponding 95% confidence intervals (CIs), and I2 in percentage representing the percentage variability in effect estimates that could be explained by heterogeneity. GRADE (Grading of Recommendations Assessment, Development, and Evaluation) was used to assess the quality of evidence.. Out of 1,385 citations, eight studies were included. Based on the interventions and comparators, studies were analyzed in 3 different groups. GB compared with placebo (3 studies, n = 185) showed minimal improvement of pain (MD = 0.22 units, 95% CI [-0.5 to 0.07] I2 = 0%; GRADE: very low). Three studies compared PG with other types of analgesic medication (n = 332) and showed greater improvement in the other analgesic group (MD = 0.42 units, 95% CI [0.20 to 0.64] I2 = 0; GRADE: very low). Studies using PG as an adjuvant (n = 423) were not pooled due to heterogeneity, but the largest of them showed no benefit of adding PG to tapentadol. There were no deaths or hospitalizations reported. Compared with placebo, the following adverse events were more commonly reported with GB: dizziness-(RR = 1.99, 95% CI [1.17 to 3.37], I2 = 49); fatigue (RR = 1.85, 95% CI [1.12 to 3.05], I2 = 0); difficulties with mentation (RR = 3.34, 95% CI [1.54 to 7.25], I2 = 0); and visual disturbances (RR = 5.72, 95% CI [1.94 to 16.91], I2 = 0). The number needed to harm with 95% CI for dizziness, fatigue, difficulties with mentation, and visual disturbances were 7 (4 to 30), 8 (4 to 44), 6 (4 to 15), and 6 (4 to 13) respectively. The GRADE evidence quality was noted to be very low for dizziness and fatigue, low for difficulties with mentation, and moderate for visual disturbances. Functional and emotional improvements were reported by few studies and showed no significant improvements.. Existing evidence on the use of gabapentinoids in CLBP is limited and demonstrates significant risk of adverse effects without any demonstrated benefit. Given the lack of efficacy, risks, and costs associated, the use of gabapentinoids for CLBP merits caution. There is need for large high-quality trials to more definitively inform this issue.. PROSPERO CRD42016034040.

Topics: Amines; Analgesics; Cyclohexanecarboxylic Acids; England; Gabapentin; gamma-Aminobutyric Acid; Humans; Low Back Pain; Pregabalin; Randomized Controlled Trials as Topic

Chronic low back pain (CLBP) is a common condition and causes significant pain, distress and disability across the world. It is multifactorial in aetiology and is challenging to manage. Although the underlying mechanism of pain is predominantly non-specific, many argue that there is a substantial neuropathic pain element. Neuropathic pain is more severe, with significant disability. Gabapentinoids, including gabapentin and pregabalin, have proven efficacy in some neuropathic pain conditions. Despite no clear evidence, a substantial population of patients with CLBP are treated with gabapentinoids.. We aim to assess whether the use of gabapentinoids is effective and safe in the treatment of predominant CLBP, by conducting a systematic review and meta-analysis of randomised control trials (RCTs).. We will search the databases of MEDLINE, EMBASE and Cochrane for RCTs published in English language and have used gabapentinoids for the treatment of CLBP. Study selection and data extraction will be performed independently by paired reviewers using structured electronic forms, piloted between pairs of reviewers. The review outcomes will be guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief as the primary outcome. We propose to carry out meta-analysis if there are three or more studies in a particular outcome domain, using a random effects model. Pooled outcomes will be reported as weighted mean differences or standardised mean differences and risk ratios with their corresponding 95% CIs, for continuous outcomes and dichotomous outcomes, respectively. Rating of quality of evidence will be reported using GRADE summary of findings table.. The proposed systematic review will be able to provide valuable evidence to help decision-making in the use of gabapentinoids for the treatment of CLBP. This will help advance patient care and potentially highlight limitations in existing evidence to direct future research.. Being a systematic review, this study would not necessitate ethical review and approval. We plan to report and publish our study findings in a high impact medical journal, with online access.. CRD42016034040.

Topics: Amines; Chronic Pain; Cyclohexanecarboxylic Acids; Gabapentin; gamma-Aminobutyric Acid; Humans; Low Back Pain; Neuralgia; Pain Management; Pain Measurement; Pregabalin; Randomized Controlled Trials as Topic; Research Design; Systematic Reviews as Topic

Cost-effectiveness model from a Quebec societal perspective using meta-analyses of clinical trials.. To evaluate the cost-effectiveness of duloxetine in chronic low back pain (CLBP) compared with other post-first-line oral medications.. Duloxetine has recently received a CLBP indication in Canada. The cost-effectiveness of duloxetine and other oral medications has not previously been evaluated for CLBP.. A Markov model was created on the basis of the economic model documented in the 2008 osteoarthritis clinical guidelines of the National Institute for Health and Clinical Excellence. Treatment-specific utilities were estimated via a meta-analysis of CLBP clinical trials and a transfer-to-utility regression estimated from duloxetine CLBP trial data. Adverse event rates of comparator treatments were taken from the National Institute for Health and Clinical Excellence model or estimated by a meta-analysis of clinical trials in osteoarthritis using a maximum-likelihood simulation technique. Costs were developed primarily from Quebec and Ontario public sources as well as the published literature and expert opinion. The 6 comparators were celecoxib, naproxen, amitriptyline, pregabalin, hydromorphone, and oxycodone. Subgroup analyses and 1-way and probabilistic sensitivity analyses were performed.. In the base case, naproxen, celecoxib, and duloxetine were on the cost-effectiveness frontier, with naproxen the least expensive medication, celecoxib with an incremental cost-effectiveness ratio of $19,881, and duloxetine with an incremental cost-effectiveness ratio of $43,437. Other comparators were dominated. Key drivers included the rates of cardiovascular and gastrointestinal adverse events and proton pump inhibitor usage. In subgroup analysis, the incremental cost-effectiveness ratio for duloxetine fell to $21,567 for a population 65 years or older and to $18,726 for a population at higher risk of cardiovascular and gastrointestinal adverse events.. The model estimates that duloxetine is a moderately cost-effective treatment for CLBP, becoming more cost-effective for populations older than 65 years or at greater risk of cardiovascular and gastrointestinal events.. 1.

Topics: Age Factors; Aged; Amitriptyline; Analgesics; Cardiovascular Diseases; Celecoxib; Chronic Disease; Clinical Trials as Topic; Cost-Benefit Analysis; Duloxetine Hydrochloride; gamma-Aminobutyric Acid; Gastrointestinal Diseases; Humans; Hydromorphone; Low Back Pain; Markov Chains; Middle Aged; Models, Economic; Naproxen; Ontario; Osteoarthritis; Outcome Assessment, Health Care; Oxycodone; Pregabalin; Pyrazoles; Quality-Adjusted Life Years; Quebec; Sulfonamides; Thiophenes

During 2008, we selected 8 studies of interest. It seems important to continue to treat high tension for old patients. To give a good medication against pain, to maintain activity and to reassure patient is the treatment for acute back pain; surgery for spinal stenosis has better results than other treatments at two years of evolution. Pregabalin seems to provide clinically benefit to patients with fibromyalgia. Helicobacter pylori test and treat has the same results than proton pomp inhibitor in initial management of dyspepsia; extending triple therapy beyond 7 days is unlikely to be a clinical useful strategy. Syphilis testing algorithms using treponemal tests for initial screening could be inversed. Finally, selective reporting of clinical trials results for antidepressant are relatively frequent.

Topics: Acute Disease; Age Factors; Aged, 80 and over; Algorithms; Ambulatory Care; Analgesics; Angiotensin-Converting Enzyme Inhibitors; Antidepressive Agents; Antihypertensive Agents; Depression; Fibromyalgia; gamma-Aminobutyric Acid; Helicobacter Infections; Helicobacter pylori; Humans; Hypertension; Indapamide; Internal Medicine; Low Back Pain; Meta-Analysis as Topic; Perindopril; Pregabalin; Randomized Controlled Trials as Topic; Spinal Stenosis; Syphilis

Topics: Administration, Cutaneous; Amines; Analgesics; Analgesics, Opioid; Antidepressive Agents; Arthritis; Chemotherapy, Adjuvant; Chronic Disease; Cyclohexanecarboxylic Acids; Diabetic Neuropathies; Diagnosis, Differential; Gabapentin; gamma-Aminobutyric Acid; Humans; Lidocaine; Low Back Pain; Pain; Pain Measurement; Pain, Postoperative; Practice Guidelines as Topic; Pregabalin; Wounds and Injuries

Although various pharmacological and nonpharmacological treatments are available for the chronic low back pain (CLBP), there is no consensus on the best optimal treatment for this condition. This study aimed to investigate the efficacy of co-administration of pregabalin and agomelatine versus pregabalin with placebo to treat CLBP.. Forty-six CLBP patients without the surgical indication referred to the outpatient orthopedic clinic of Rasoul-e-Akram Hospital, Tehran, Iran, were randomly divided into two study groups: Group A [pregabalin (75 mg twice per day) + placebo] and Group B [pregabalin (75 mg twice per day) + agomelatine (25 mg per night)]. Patients were evaluated at weeks 0, 4, and 8. Outcome measures were the Persian versions of the Brief Pain Inventory (BPI) interference scale, Roland-Morris Disability Questionnaire (RMDQ), The Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Survey (SF-36), and General Health Questionnaire-28 (GHQ-28) were used.. At weeks 4 and 8 after the intervention, all evaluated measures showed significant improvement in both study groups (P < 0.01). The mean improvement of GHQ-28 was 3.7 ± 1.22 in group A and 13.1 ± 4.71 in group B. This difference was statistically significant (P = 0.003). Other outcomes did not vary substantially between the two research groups. Agomelatine treatment was well tolerated, with no significant adverse effects seen in patients. Liver tests of all patients were routine during the study period. Major adverse effect was not seen in any patient. The prevalence of Minor side effects was not significantly different between two study groups.. Compared with the pregabalin and placebo, co-administration of pregabalin and agomelatine had no added effect on improving pain scores in CLBP patients. However, the patients' general health was significantly improved after the combined administration of pregabalin and agomelatine.. The study protocol was registered in the Iranian Registry of Clinical Trials before starting the study (NO.IRCT20200620047852N1, Registration date: 23/06/2020).

Topics: Acetamides; Double-Blind Method; Humans; Iran; Low Back Pain; Naphthalenes; Pain Measurement; Pregabalin; Treatment Outcome

Although both pregabalin and gabapentin are known to be useful for treating lumbar radiating pain and reducing the incidence of surgery, the oral corticosteroids sometimes offer a dramatic effect on severe radiating pain despite the lack of scientific evidence.. A total of 54 patients were enrolled among 703 patients who complained of lumbar radiating pain. Twenty patients who received an oral corticosteroid was classified as group A and 20 patients who received the control drugs (pregabalin or gabapentin) as group B. Oswestry Disability Index (ODI), Revised Roland Morris disability questionnaire (RMDQ), Short Form 36 (SF-36) questionnaire, lumbar radiating pain, objective patient satisfaction, and objective improvement of patients or physicians were assessed at 2, 6, and 12 weeks after medication.. No difference in the sex ratio and age was observed between the groups (p = 0.70 and p = 0.13, respectively). Group A showed greater improvement in radiating pain after 2, 6, and 12 weeks than group B (p < 0.001, p = 0.001, and p < 0.001, respectively). No differences were observed between the groups in satisfaction at the beginning and 12 weeks after taking the medication (p = 0.062 and p = 0.061, respectively) and in objective improvement of patients and physicians (p = 0.657 and p = 0.748, respectively). Group A was less disabled and had greater physical health scores than group B (p = 0.014 and p = 0.017, respectively).. Oral corticosteroids for the treatment of lumbar radiating pain can be more effective in pain relief than gabapentin or pregabalin. The satisfaction of patients and physicians with the drug and objective improvement status were not inferior to that with gabapentin or pregabalin.

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Amines; Analgesics; Cyclohexanecarboxylic Acids; Female; Gabapentin; gamma-Aminobutyric Acid; Humans; Low Back Pain; Lumbosacral Region; Male; Middle Aged; Patient Satisfaction; Pregabalin; Quality of Life; Radiculopathy; Surveys and Questionnaires; Young Adult

To evaluate the effectiveness and tolerability of tapentadol PR monotherapy versus tapentadol PR/pregabalin combination therapy for severe, chronic low back pain with a neuropathic component.. Eligible patients had painDETECT "unclear" or "positive" ratings and average pain intensity ≥ 6 (11-point NRS-3 [average 3-day pain intensity]) at baseline. Patients were titrated to tapentadol PR 300 mg/day over 3 weeks. Patients with ≥ 1-point decrease in pain intensity and average pain intensity ≥ 4 were randomized to tapentadol PR (500 mg/day) or tapentadol PR (300 mg/day)/pregabalin (300 mg/day) during an 8-week comparative period.. In the per-protocol population (n = 288), the effectiveness of tapentadol PR was clinically and statistically comparable to tapentadol PR/pregabalin based on the change in pain intensity from randomization to final evaluation (LOCF; LSMD [95% CI], -0.066 [-0.57, 0.43]; P < 0.0001 for noninferiority). Neuropathic pain and quality-of-life measures improved significantly in both groups. Tolerability was good in both groups, in line with prior trials in the high dose range of 500 mg/day for tapentadol PR monotherapy, and favorable compared with historical combination trials of strong opioids and anticonvulsants for combination therapy. The incidence of the composite of dizziness and/or somnolence was significantly lower with tapentadol PR (16.9%) than tapentadol PR/pregabalin (27.0%; P = 0.0302).. Tapentadol PR 500 mg is associated with comparable improvements in pain intensity and quality-of-life measures to tapentadol PR 300 mg/pregabalin 300 mg, with improved central nervous system tolerability, suggesting that tapentadol PR monotherapy may offer a favorable treatment option for severe low back pain with a neuropathic component.

Topics: Adult; Aged; Analgesics; Chronic Pain; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Internationality; Low Back Pain; Male; Middle Aged; Neuralgia; Pain Management; Phenols; Pregabalin; Severity of Illness Index; Tapentadol; Treatment Outcome

Pregabalin and opioids are used to treat chronic low back pain (LBP). No previous investigations have compared the efficacy of pregabalin and that of opioids for chronic LBP.. We performed a randomized controlled trial of pregabalin and opioids in 65 consecutive patients aged 65 years or older who had chronic LBP. Each agent was administered randomly in different phases. Pain and activities of daily living (ADL) were evaluated after 4 weeks of treatment using the visual analog scale, Japanese Orthopaedic Association score, Roland Morris Disability Questionnaire, short-form McGill Pain Questionnaire, EuroQol quality-of-life scale, and geriatric depression scale. Neuropathic pain was evaluated using a neuropathic pain screening questionnaire.. The effectiveness rate was 73.3% for pregabalin and 83.3% for opioid, showing no significant difference. The mean durations until the onset of effect were 10.2 and 6.1 days, respectively, albeit without significant difference. Pregabalin was effective for LBP with neuropathic pain, whereas opioids were effective for non-neuropathic pain. The improvement of ADL was greater with opioids than with pregabalin. Pregabalin was effective for LBP in patients with lower limb symptoms, whereas opioids were effective for those without lower limb symptoms.. Aside from screening tests, consideration of neuropathic pain and lower extremity symptoms may be an integral component in the selection of the appropriate medication for chronic LBP. Moreover, the therapeutic objectives, including pain relief and/or improvement of ADL, should be specified.

Topics: Activities of Daily Living; Aged; Aged, 80 and over; Analgesics, Non-Narcotic; Analgesics, Opioid; Female; Humans; Low Back Pain; Male; Neuralgia; Pain Measurement; Pregabalin; Treatment Outcome

There is no head on comparison of amitriptyline (AMT) and pregabalin (PG) in relieving pain and disability in chronic low backache (CLBA). This randomized controlled trial reports the efficacy and safety of AMT and PG in CLBA.. Patients with CLBA, 15-65 years of age without specific cause and significant neurological deficit were included. Severity of pain was assessed by Visual Analogue Scale (VAS) and disability by Oswestry Disability Index (ODI). Patients were followed up at 6 and 14 weeks and their VAS score, ODI and side effect were noted. Primary outcome was pain relief (>50% improvement in VAS score) at 14 weeks and secondary outcome were reduction in ODI (>20%) and side effects.. 200 patients with CLBA were randomized to AMT (n=103) and PG (n=97) using random numbers. The VAS score and ODI improved significantly following AMT and PG at 6 and 14 weeks compared to baseline. The improvement in pain (57.3% Vs 39.2%; P=0.01) and disability (65% Vs 49.5%; P=0.03) however was more in AMT group. The composite side effects were similar in both groups.. AMT and PG are effective in CLBA but AMT reduced pain and disability significantly compared to PG.

Topics: Adolescent; Adult; Aged; Amitriptyline; Analgesics, Non-Narcotic; Chronic Disease; Disability Evaluation; Female; gamma-Aminobutyric Acid; Humans; Low Back Pain; Male; Middle Aged; Pain Measurement; Pregabalin; Treatment Outcome; Young Adult

The efficacy and safety of the association of celecoxib [a selective cyclooxygenase-2 (COX-2) inhibitor] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms.. In this prospective randomized trial, 36 patients received three consecutive 4-week treatment regimes, randomly assigned: celecoxib plus placebo, pregabalin plus placebo, and celecoxib plus pregabalin. All patients were assessed by using a visual analogue scale (VAS, 0-100 mm) and the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale by an investigator blinded to the administered pharmacological treatment.. Celecoxib and pregabalin were effective in reducing low-back pain when patients were pooled according to LANSS score. The association of celecoxib and pregabalin was more effective than either monotherapy in a mixed population of patients with chronic low-back pain and when data were pooled according to LANSS score. Adverse effects of drug association and monotherapies were similar, with reduced drug consumption in the combined therapy.. Combination of celecoxib and pregabalin is more effective than monotherapy for chronic low-back pain, with similar adverse effects.

Topics: Adult; Aged; Analgesics; Celecoxib; Chronic Disease; Cyclooxygenase 2 Inhibitors; Drug Therapy, Combination; Female; gamma-Aminobutyric Acid; Humans; Low Back Pain; Male; Middle Aged; Pain Measurement; Pregabalin; Pyrazoles; Single-Blind Method; Sulfonamides; Treatment Outcome

Pain intensity is frequently measured on an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=worst possible pain. However, it is difficult to interpret the clinical importance of changes from baseline on this scale (such as a 1- or 2-point change). To date, there are no data driven estimates for clinically important differences in pain intensity scales used for chronic pain studies. We have estimated a clinically important difference on this scale by relating it to global assessments of change in multiple studies of chronic pain. Data on 2724 subjects from 10 recently completed placebo-controlled clinical trials of pregabalin in diabetic neuropathy, postherpetic neuralgia, chronic low back pain, fibromyalgia, and osteoarthritis were used. The studies had similar designs and measurement instruments, including the PI-NRS, collected in a daily diary, and the standard seven-point patient global impression of change (PGIC), collected at the endpoint. The changes in the PI-NRS from baseline to the endpoint were compared to the PGIC for each subject. Categories of "much improved" and "very much improved" were used as determinants of a clinically important difference and the relationship to the PI-NRS was explored using graphs, box plots, and sensitivity/specificity analyses. A consistent relationship between the change in PI-NRS and the PGIC was demonstrated regardless of study, disease type, age, sex, study result, or treatment group. On average, a reduction of approximately two points or a reduction of approximately 30% in the PI-NRS represented a clinically important difference. The relationship between percent change and the PGIC was also consistent regardless of baseline pain, while higher baseline scores required larger raw changes to represent a clinically important difference. The application of these results to future studies may provide a standard definition of clinically important improvement in clinical trials of chronic pain therapies. Use of a standard outcome across chronic pain studies would greatly enhance the comparability, validity, and clinical applicability of these studies.

Topics: Adult; Aged; Aged, 80 and over; Anticonvulsants; Chronic Disease; Controlled Clinical Trials as Topic; Female; Fibromyalgia; gamma-Aminobutyric Acid; Humans; Low Back Pain; Male; Middle Aged; Neuralgia; Osteoarthritis; Pain Measurement; Pregabalin; Treatment Outcome

Lumbar radiculopathy can be presented as low back pain and radiating pain. Transforaminal epidural steroid injection (TFESI) has been used to treat radicular pain, and after the injection, additional medications such as gabapentinoids including pregabalin (PGB) and gabapentin (GBP) can be administered to relieve remnant pain. However, little is known about the effectiveness of gabapentinoids in relieving pain after transforaminal epidural steroid injection. This study was conducted to compare the effect of pregabalin and gabapentin in lumbar radiculopathy patients who underwent transforaminal epidural steroid injection. One hundred seven patients who received TFESI and had taken PGB or GBP after the intervention at Daegu Catholic University Medical Center from January 2013 to August 2021 were included in this study. Visual Analogue Scale (VAS) was evaluated in all patients. Among 107 patients, 57 (53.3%) patients took PGB and 50 (46.7%) patients took GBP after TFESI. The PGB and GBP groups showed reduced VAS scores according to visit (P < .001). However, no statistically significant differences in VAS scores according to the types of medication (P = .811) and change aspects according to visit were observed between the PGB and GBP groups (P = .947). The study findings suggest that both pregabalin and gabapentin can be equally used to reduce pain in lumbar radiculopathy patients who underwent TFESI. Further studies with larger sample size are needed to generalize the findings of this study.

Topics: Gabapentin; Humans; Injections, Epidural; Low Back Pain; Lumbar Vertebrae; Nerve Block; Pregabalin; Radiculopathy; Steroids; Treatment Outcome

We compared the reduction in pain and opioid consumption in patients with chronic spinal pain on concomitant gabapentinoids and opioids with patients using opioids only.. This was a retrospective chart review of patients with chronic neck or low back pain who were on opioids with at least a 24-month follow-up.. Single-center pain clinic in an urban setting.. 167 patients with chronic spinal pain lasting at least six months.. Patients on gabapentin or pregabalin were included in the gabapentinoid group, while the other patients were included in the non-gabapentinoid group. Primary outcome was assessment of pain scores measured via a numeric rating scale (NRS), and secondary outcomes were response to the treatment (>2 point reduction on NRS) and daily opioid use measured in morphine milliequivalents.. Pain scores were reduced in the first six months and plateaued after that in both groups. At the end of 24 months, the average pain score was 6.71 in the gabapentinoid group, while the average pain score was 7.18 in the non-gabapentinoid group. There was no statistical significance between the groups (p = 0.28). There was no difference in response to treatment in gabapentinoid group (33.3%) when compared with non-gabapentinoid group (32.7%). We also failed to find any significant difference in daily opioid usage between the two groups.. Gabapentinoids may not lead to reduction in pain or opioid consumption in patients with chronic spinal pain. A careful approach must be adopted while prescribing gabapentinoids in the chronic spinal pain patient population.

Topics: Analgesics, Opioid; Gabapentin; Humans; Low Back Pain; Pregabalin; Retrospective Studies

Pregabalin and gabapentin are similar compounds with analgesic, anticonvulsant, and anxiolytic characteristics. Due to these pharmacological features, they are commonly used throughout the world in neuropathic pain treatment and anxiety disorders. Mild to moderate side effects of the central nervous system, such as dizziness and somnolence, are important factors in deciding to terminate the use of pregabalin. Studies have also reported that the use of dose-dependent pregabalin resulted in peripheral edema and weight gain. Described in this case report is hearing loss occurring after an increase in the drug dose of a patient using pregabalin.In this case, we wanted to present the occuring hearing-loss after an increase in the drug dose of the patient already using pregabalin.

Topics: Aged; Analgesics; Diagnosis, Differential; Hearing Loss; Humans; Low Back Pain; Male; Pregabalin

Topics: Adult; Cross-Over Studies; Gabapentin; Humans; Low Back Pain; Pregabalin; Sciatica

Topics: Adult; Cross-Over Studies; Gabapentin; Humans; Low Back Pain; Pregabalin; Sciatica

Topics: Humans; Low Back Pain; Peer Review; Physiatrists; Pregabalin; Sciatica

Topics: Aged; Analgesics; Chemical and Drug Induced Liver Injury; Chronic Pain; Female; Humans; Low Back Pain; Pregabalin

In this report we describe a patient who developed liver failure due to new administration of pregabaline.. A 76-year old woman was admitted with a sacral fracture after conservative treatment in a trauma surgery ward for further rehabilitative treatment.. At admittance the patient complaint of lower back pain. Physical examination revealed unsteadiness in walking tests. Laboratory tests revealed mildly elevated infection parameters (CRP 0.67 mg / dl) and alkaline phosphatase (191U / I).. Physical training was initiated. Multimodal therapy for pain was continued with tilidin / naloxon, which had been started at the trauma surgery ward. Due to persistent pain and its radicular nature additional pregabaline treatment was initiated. Ten days thereafter the patient developed nausea without vomiting and subsequently (day 15) jaundice. Blood examination revealed elevated liver enzymes (ALT 246U / I, AST 86U / I, GGT 2068U / I and bilirubine 6 mg / dl). Abdominal sonography and MRCP were normal. After discontinuation of pregabaline treatment nausea disappeared within several days and liver enzymes declined to normal values within several weaks.. Pregabaline should be taken into account as cause of acute liver failure.

Topics: Aged; Analgesics; Chemical and Drug Induced Liver Injury; Diagnosis, Differential; Female; Humans; Liver Failure, Acute; Low Back Pain; Pregabalin

The anti-seizure drug pregabalin is currently used for peripheral neuropathic pain, including degenerative lumbar disease with a neuropathic component. Although there are many reports associated with pregabalin, treatment outcome in low back pain (LBP) patients with depression remains uncertain. This study investigated the outcomes of pregabalin in LBP patients with depression.. We assessed 64 patients (29 men and 35 women) using a Visual Analogue Scale, a Self-Rating Depression Scale (SDS) and the Oswestry Disability Index (ODI). Mean age was 63.3 years (range 20-81), and mean duration of disease was 69.8 months (range 3-576). The patients were divided into two groups according to SDS: normal (n = 37) and depressed group (n = 27).. Pregabalin significantly reduced both SDS and ODI in the depressed group (p < 0.05). Effect size was larger for both SDS and ODI in the depressed group than in the normal group. Pain was significantly relieved, even in the depressed group (p < 0.01). Pain reduction was achieved by the direct effect of pregabalin, as well as indirect effects attributed to change in depressive symptoms. Although both somnolence and dizziness were detected, the use of hypnotic agents was decreased in half of cases. Somnolence did not influence the analgesic effects of the drug or psychotic state.. This investigation indicated that pregabalin is safe and effective for reducing both LBP and mood disturbance in patients with depression.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics; Depression; Disability Evaluation; Dose-Response Relationship, Drug; Female; Follow-Up Studies; gamma-Aminobutyric Acid; Humans; Low Back Pain; Lumbar Vertebrae; Male; Middle Aged; Outpatients; Pregabalin; Psychometrics; Retrospective Studies; Spinal Diseases; Surveys and Questionnaires; Time Factors; Treatment Outcome; Visual Analog Scale; Young Adult

Topics: Analgesics; Drug Industry; gamma-Aminobutyric Acid; Humans; Low Back Pain; Medicalization; Neuralgia; Pregabalin

Topics: Acute Disease; Analgesics; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Chronic Disease; Controlled Clinical Trials as Topic; Early Ambulation; gamma-Aminobutyric Acid; Humans; Iatrogenic Disease; Low Back Pain; Magnetic Resonance Imaging; Neuralgia; Pregabalin; Time Factors

Topics: Adult; Analgesics; Delirium; Female; gamma-Aminobutyric Acid; Hallucinations; Humans; Low Back Pain; Pregabalin; Psychoses, Substance-Induced

Degeneration of the interverterbral disk is as a cause of low-back pain is increasing. To gain insight into relationships between biological processes, structural alterations and behavioral pain, we created an animal model in rats.. Disk degeneration was induced by removal of the nucleus pulposus (NP) from the lumbar disks (L4/L5 and L5/L6) of Sprague Dawley rats using a 0.5-mm-diameter microsurgical drill. The degree of primary hyperalgesia was assessed by using an algometer to measure pain upon external pressure on injured lumbar disks. Biochemical and histological assessments and radiographs of injured disks were used for evaluation. We investigated therapeutic modulation of chronic pain by administering pharmaceutical drugs in this animal model.. After removal of the NP, pressure hyperalgesia developed over the lower back. Nine weeks after surgery we observed damaged or degenerated disks with proteoglycan loss and narrowing of disk height. These biological and structural changes in disks were closely related to the sustained pain hyperalgesia. A high dose of morphine (6.7 mg/kg) resulted in effective pain relief. However, high doses of pregabalin (20 mg/kg), a drug that has been used for treatment of chronic neuropathic pain, as well as the anti-inflammatory drugs celecoxib (50 mg/kg; a selective inhibitor of cyclooxygenase 2 (COX-2)) and ketorolac (20 mg/kg; an inhibitor of COX-1 and COX-2), did not have significant antihyperalgesic effects in our disk injury animal model.. Although similarities in gene expression profiles suggest potential overlap in chronic pain pathways linked to disk injury or neuropathy, drug-testing results suggest that pain pathways linked to these two chronic pain conditions are mechanistically distinct. Our findings provide a foundation for future research on new therapeutic interventions that can lead to improvements in the treatment of patients with back pain due to disk degeneration.

Topics: Animals; Disease Models, Animal; gamma-Aminobutyric Acid; Intervertebral Disc Degeneration; Low Back Pain; Lumbar Vertebrae; Pain Measurement; Pregabalin; Rats; Rats, Sprague-Dawley

low back pain is one of the most common reasons for outpatient consultation in both the primary-care and specialized-care settings. However, few studies have explored the effect of pregabalin in this context.. to prospectively analyse the effect of adding pregabalin on costs and consequences in the treatment of refractory low back pain in routine medical practice.. a secondary analysis was carried out in patients aged >or=18 years with a 6-month history of chronic refractory low back pain who had participated in a previous prospective, naturalistic, 12-week, two-visit study (RADIO study). The analysis compared patients receiving pregabalin with those receiving usual care. Severity of pain, healthcare resources utilization, lost workday equivalents due to pain, and related cost-adjusted reductions were assessed. The year of costing for all cost data reported in the study was 2007.. data from a total of 683 patients (49.5% women, mean age 55.0 years), 82.6% of whom were receiving pregabalin, were analysed. Pregabalin was associated with a higher covariable-adjusted reduction in severity of pain, i.e. mean (SD) -3.4 (2.0) compared with -2.0 (2.1) points with usual care on a 10-point neuropathic pain questionnaire (p < 0.001), and a 61.6% response rate (defined as >/=50% reduction in pain from baseline) compared with 37.3% with usual care (p < 0.001). This resulted in fewer lost workday equivalents in the pregabalin group versus usual care (27.8 vs 34.6, p = 0.002), which produced more significant adjusted reductions in indirect costs, i.e. mean (SD) -euro961.8 (euro1242.9) compared with -euro625.8 (euro1169.2) with usual care (p = 0.004). The cost of pregabalin, i.e. mean (SD) euro303.8 (euro175.8) compared with euro37.1 (euro97.0) for usual care (p < 0.001), was offset by larger reductions in the other cost components. While the adjusted total costs were substantially reduced in both groups, pregabalin-treated patients showed more significant reductions, i.e. mean (SD) -euro991.5 (euro1702.3) compared with -euro579.3 (euro2410.3) with usual care (p = 0.023).. compared with usual care, addition of pregabalin to existing therapy for refractory low back pain was associated with a larger reduction in pain severity and lost workday equivalents. The acquisition cost of pregabalin was offset by a higher reduction in the indirect components of cost, resulting in a significant decrease in total costs.

Topics: Adult; Aged; Analgesics; Female; gamma-Aminobutyric Acid; Health Care Costs; Humans; Low Back Pain; Male; Middle Aged; Orthopedic Procedures; Pregabalin; Prospective Studies

Topics: Analgesics; Calcium Channels; Central Nervous System; Clinical Trials as Topic; gamma-Aminobutyric Acid; Humans; Low Back Pain; Neuralgia; Pain Measurement; Pregabalin; Prospective Studies; Radiculopathy; Treatment Outcome