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Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings.

ABSTRACT: Background: Despite high prevalence of chronic neck pain in Japan and the negative impact pain has on patient's quality of life (QoL), the therapeutic value of pregabalin for chronic neck pain with a neuropathic pain (NeP) component has not been assessed in a typical Japanese health care setting. Methods: An 8-week, non-interventional, multicenter, observational study of Japanese adults (?20 years) with chronic refractory cervical pain including a NeP element (for ?12 weeks) and sleep disturbance on the Pain-Related Sleep-Interference Scale (PRSIS) ?1 (from 0 "does not interfere with sleep" to 10 "completely interferes"). Patients received either usual care with conventional analgesics or pregabalin (150-600 mg/day) for 8 weeks. "Usual care" with analgesics or other treatment(s) was determined based on physician's best clinical judgment. Primary endpoint was change from baseline to week 8 in PRSIS. Secondary endpoints included: change from baseline to week 4 in PRSIS, and to week 4 and 8 in pain Numerical Rating Scale (NRS; from 0 "no pain" to 10 "worst possible pain"), and on the Neck Disability Index (NDI). Other assessments of QoL were undertaken. Safety was monitored. Results: Overall, 369 patients received pregabalin (n=145) or usual care (n=224). The median (range) dose of pregabalin was 49.6 (25.0-251.5) mg/day. Least-squares mean change in PRSIS from baseline to week 8 favored pregabalin (-1.167 vs -0.269; treatment difference -0.898 [95% CI -1.262, -0.535], P<0.001). Similar observations were seen at week 4 in favor of pregabalin versus usual care (P<0.001). Pregabalin significantly improved pain NRS and NDI scores at weeks 4 and 8 (all P<0.001). Improvements in QoL versus usual care were also observed. Pregabalin was generally well tolerated. Conclusion: In this open-label study, pregabalin improved PRSIS and resulted in clinically meaningful reductions in pain in Japanese patients with NeP associated with chronic cervical pain. ClinicalTrials.gov identifier: NCT02868359.

SUBMITTER: Taguchi T

PROVIDER: S-EPMC6506009 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings.

Taguchi Toshihiko T Nozawa Kazutaka K Parsons Bruce B Yoshiyama Tamotsu T Ebata Nozomi N Igarashi Ataru A Fujii Koichi K

Journal of pain research 20190503

<b>Background:</b> Despite high prevalence of chronic neck pain in Japan and the negative impact pain has on patient's quality of life (QoL), the therapeutic value of pregabalin for chronic neck pain with a neuropathic pain (NeP) component has not been assessed in a typical Japanese health care setting. <b>Methods:</b> An 8-week, non-interventional, multicenter, observational study of Japanese adults (≥20 years) with chronic refractory cervical pain including a NeP element (for ≥12 weeks) and sl ...[more]

PMID: 31118759

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Project description:BackgroundRegarding musculoskeletal conditions, patient's psychological distress, are shown to be associated with higher disability. Cervical radiculopathy (CR) and carpal tunnel syndrome (CTS), are two conditions caused by entrapment of cervical nerve roots and carpal median nerve, respectively. This study aims to investigate the association of psychological factors including depression, anxiety, and pain catastrophizing, with measures of upper limb patient-reported and performance-based disability, in patients with CR, and compare the obtained results with our similar study on CTS.MethodsIn a cross-sectional study, we recruited 92 patients with CR, and investigated their disability level using patient-reported questionnaires (Quick Disabilities of the Arm, Shoulder and Hand (DASH) and pain Likert Scale) and by measuring grip and pinch strength. We also assessed their psychological status with Hospital Anxiety and Depression Scale questionnaire for depression (HADS-D) and anxiety (HADS-A) and also Pain Catastrophizing Scale (PCS) tools. We performed correlational coefficient analysis between disability and psychological scores and regression analysis of dependent variables (Pain, DASH, grip and pinch scores) and independent (psychological) variables. Finally, Z observed value was calculated to compare correlational coefficients between two diseases of CTS and CR.ResultsThe results of the correlational coefficient analysis indicate that all three HADS-A, HADS-D and PCS scores correlated with DASH score (r = 0.49, 0.37, 0.38 for HADS-A, HADS-D and PCS, respectively; p < 0.001 for all three). HADS-A also significantly correlated with VAS pain score (r = 0.41, P < 0.001) and grip strength (r = - 0.25, P = 0.016). Linear regression analysis revealed that anxiety has a notable value for DASH and VAS pain scores as well as grip strength. Fisher's r correlation coefficient to z transformation, revealed that there was no difference between two diseases of CTS and CR in terms of the resulted r coefficients from correlational coefficient analysis between disability and psychological distress.ConclusionIt is concluded that psychological disorders are associated with disability in CR patients, with anxiety also correlating with objective disability parameter of grip strength. Finally, both CTS and CR patients' disabilities associate with anxiety, depression, and catastrophysing thinking in a similar manner.Level of evidenceLevel IV (cross-sectional study).

Project description:BackgroundVirtual reality-based training has found increasing use in neurorehabilitation to improve upper limb training and facilitate motor recovery.ObjectiveThe aim of this study was to directly compare virtual reality-based training with conventional therapy.MethodsIn a multi-center, parallel-group randomized controlled trial, patients at least 6 months after stroke onset were allocated either to an experimental group (virtual reality-based training) or a control group receiving conventional therapy (16x45 minutes within 4 weeks). The virtual reality-based training system replicated patients´ upper limb movements in real-time to manipulate virtual objects. Blinded assessors tested patients twice before, once during, and twice after the intervention up to 2-month follow-up for dexterity (primary outcome: Box and Block Test), bimanual upper limb function (Chedoke-McMaster Arm and Hand Activity Inventory), and subjective perceived changes (Stroke Impact Scale).Results54 eligible patients (70 screened) participated (15 females, mean age 61.3 years, range 20-81 years, time since stroke 3.0±SD 3 years). 22 patients were allocated to the experimental group and 32 to the control group (3 drop-outs). Patients in the experimental and control group improved: Box and Block Test mean 21.5±SD 16 baseline to mean 24.1±SD 17 follow-up; Chedoke-McMaster Arm and Hand Activity Inventory mean 66.0±SD 21 baseline to mean 70.2±SD 19 follow-up. An intention-to-treat analysis found no between-group differences.ConclusionsPatients in the experimental and control group showed similar effects, with most improvements occurring in the first two weeks and persisting until the end of the two-month follow-up period. The study population had moderate to severely impaired motor function at entry (Box and Block Test mean 21.5±SD 16). Patients, who were less impaired (Box and Block Test range 18 to 72) showed higher improvements in favor of the experimental group. This result could suggest that virtual reality-based training might be more applicable for such patients than for more severely impaired patients.Trial registrationClinicalTrials.gov NCT01774669.

Project description:ObjectiveTo evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy.DesignRandomised controlled trial.SettingNeurology outpatient clinics in three Dutch hospitals.Participants205 patients with symptoms and signs of cervical radiculopathy of less than one month's durationInterventionsTreatment with a semi-hard collar and taking rest for three to six weeks; 12 twice weekly sessions of physiotherapy and home exercises for six weeks; or continuation of daily activities as much as possible without specific treatment (control group).Main outcome measuresTime course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks.ResultsIn the wait and see group, arm pain diminished by 3 mm/week on the visual analogue scale (beta=-3.1 mm, 95% confidence interval -4.0 to -2.2 mm) and by 19 mm in total over six weeks. Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction (collar: beta=-1.9 mm, -3.3 to -0.5 mm; physiotherapy: beta=-1.9, -3.3 to -0.8), resulting in an extra pain reduction compared with the control group of 12 mm after six weeks. In the wait and see group, neck pain did not decrease significantly in the first six weeks (beta=-0.9 mm, -2.0 to 0.3). Treatment with the collar resulted in a weekly reduction on the visual analogue scale of 2.8 mm (-4.2 to -1.3), amounting to 17 mm in six weeks, whereas physiotherapy gave a weekly reduction of 2.4 mm (-3.9 to -0.8) resulting in a decrease of 14 mm after six weeks. Compared with a wait and see policy, the neck disability index showed a significant change with the use of the collar and rest (beta=-0.9 mm, -1.6 to -0.1) and a non-significant effect with physiotherapy and home exercises.ConclusionA semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy. Trial registration Clinical trials NCT00129714.

Dataset Information

Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings.

Publications

Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings.

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