Tolerability and efficacy of tapentadol extended release in elderly patients ≥75 years of age with chronic osteoarthritis knee or low back pain

Objective: Management of chronic pain in elderly adult patients is often complicated by analgesic medication–related side effects. This post hoc analysis of pooled data evaluated the tolerability and analgesic efficacy of tapentadol extended release (ER) compared with oxycodone controlled release (CR) in elderly adult patients (≥75 years of age) with moderate to severe, chronic osteoarthritis knee or low back pain.Methods: Data were pooled from three similarly designed, randomized, double-blind, placebo- and active-controlled, phase 3 studies of tapentadol ER for moderate to severe, chronic osteoarthritis knee (NCT00421928, NCT00486811) or low back (NCT00449176) pain, and data for patients ≥75 years of age were evaluated. Each study consisted of a 3-week titration and 12-week maintenance period. Patients received placebo, tapentadol ER (100-250 mg bid), or oxycodone HCl CR (20-50 mg bid). Tolerability was evaluated using adverse event reporting. Efficacy was evaluated using pain intensity ratings (11-point numerical rating scale).Results: For patients ≥75 years of age (n = 210), incidences of gastrointestinal treatment-emergent adverse events (TEAEs) overall and TEAEs of vomiting and the composite of nausea and/or vomiting were significantly lower in the tapentadol ER group compared with the oxycodone CR group (all p ≤ 0.0206). Tapentadol ER treatment was associated with significant reductions in pain intensity from baseline to week 15 compared with placebo (p = 0.0075); differences between the oxycodone CR and placebo groups failed to reach statistical significance (p = 0.1195), likely related to a higher treatment discontinuation rate in the oxycodone CR group. No significant differences were observed between the tapentadol ER and oxycodone CR groups in the change in pain intensity from baseline to week 15 (p = 0.2135). Conclusions: In elderly adult patients ≥75 years of age with moderate to severe, chronic osteoarthritis knee or low back pain, tapentadol ER (100-250 mg bid) provided significant pain relief compared with placebo and had a better overall gastrointestinal tolerability profile than oxycodone CR.

Download Full-text

A Preliminary Study of the Objective Measurement of Compliance Rates for Semirigid Lumbar-Support Use in Patients with Chronic Nonspecific Low Back Pain: How Important Is the Compliance Rate?

Asian Spine Journal ◽

10.4184/asj.2017.11.5.748 ◽

2017 ◽

Vol 11 (5) ◽

pp. 748-755 ◽

Cited By ~ 2

Author(s):

Maryam Hekmatfard ◽

Mohammad Ali Sanjari ◽

Nader Maroufi ◽

Hassan Saeedi ◽

Esmail Ebrahimi ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Rating Scale ◽

Compliance Rate ◽

Low Back ◽

Fear Avoidance ◽

Fear Avoidance Beliefs ◽

Lumbar Support ◽

Mean Compliance

<sec><title>Study Design</title>Clinical pilot study.</sec><sec><title>Purpose</title>To objectively evaluate the compliance rate of lumbar-support use in patients with chronic nonspecific low back pain, as well as to assess low back pain intensity, disability, and fear-avoidance beliefs.</sec><sec><title>Overview of Literature</title>Wearing time is an important factor in the assessment of the efficacy of lumbar-support use in patients with chronic nonspecific low back pain. Previous studies have measured lumbar-support wearing time based on subjective assessment, and these evaluations are not easily verifiable and are usually overestimated by subjects.</sec><sec><title>Methods</title>Twelve subjects with chronic nonspecific low back pain who had been wearing semirigid lumbar supports for 6 weeks were evaluated. Compliance was objectively monitored using temperature sensors integrated into the semirigid lumbar supports. Subjects wore their lumbar supports for 8 hour/day on workdays and 3 hour/day on holidays during the first 3 weeks. During the next 3 weeks, subjects were gradually weaned off the lumbar supports. Pain intensity was measured using a numerical rating scale. The Oswestry disability index was used to assess the subjects' disability. Fear-avoidance behavior was evaluated using a fear-avoidance beliefs questionnaire.</sec><sec><title>Results</title>The mean compliance rate of the subjects was 78.16%±13.9%. Pain intensity was significantly lower in patients with a higher compliance rate (<italic>p</italic>=0.001). Disability index and fear-avoidance beliefs (functional outcomes) significantly improved during the second 3-weeks period of the treatment (<italic>p</italic><0.001, <italic>p</italic>=0.02, respectively).</sec><sec><title>Conclusions</title>The compliance rate of patients wearing lumbar supports is a determining factor in chronic low back pain management. Wearing semirigid lumbar supports, as advised, was associated with decreased pain intensity, improved disability index scores, and improved fear-avoidance beliefs in patients with chronic nonspecific low back pain.</sec>

Download Full-text

A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/9502718 ◽

2017 ◽

Vol 2017 ◽

pp. 1-9 ◽

Cited By ~ 3

Author(s):

Xue Zhang ◽

Yang Wang ◽

Zhao Wang ◽

Chao Wang ◽

Wentao Ding ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Rating Scale ◽

Leg Pain ◽

Secondary Outcome ◽

Low Back ◽

Medium Frequency

Objective. To investigate the short- and long-term effects of electroacupuncture (EA) compared with medium-frequency electrotherapy (MFE) on chronic discogenic sciatica.Methods. One hundred participants were randomized into two groups to receive EA (n=50) or MFE (n=50) for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI), patient global impression (PGI), drug use frequency, and EA acceptance.Results. The mean changes in the average leg pain numerical rating scale (NRS) scores were 2.30 (1.86–2.57) and 1.06 (0.62–1.51) in the EA and MFE groups at week 4, respectively. The difference was significant (P<0.001). The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70–2.53) and 0.36 (−0.05–0.78) from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred.Conclusions. EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifierChiCTR-IPR-15006370.

Download Full-text

Dose Conversion Between Tapentadol Immediate and Extended Release for Low Back Pain

January 2018 - Pain Physician ◽

10.36076/ppj.2010/13/61 ◽

2010 ◽

Vol 1;13 (1;1) ◽

pp. 61-70

Author(s):

Mila S. Etropolski

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Chronic Low Back Pain ◽

Extended Release ◽

Immediate Release ◽

Low Back ◽

Open Label ◽

Double Blind ◽

The Mean

Background: Tapentadol, a novel, centrally acting analgesic with 2 mechanisms of action (µopioid receptor agonism and norepinephrine reuptake inhibition), has been developed in an immediate-release (IR) and an extended-release (ER) formulation. Determination of the safety and equianalgesic ratios for conversion between formulations is important for physicians with patients taking tapentadol IR who may want to switch to tapentadol ER, or vice versa, for any reason. Objectives: To test whether the total daily dose (TDD) of tapentadol IR may be directly converted into a comparable TDD of tapentadol ER, and vice versa, with equivalent efficacy and comparable safety. Study Design: Randomized, double-blind, 2-period (2 weeks each) crossover study. Setting: Study centers (N = 13) in the United States. Methods: Patients with moderate to severe chronic low back pain received tapentadol IR 50, 75, or 100 mg every 4 or 6 hours (maximum TDD, 500 mg) during the 3-week open-label period to identify an optimal, stable dose of tapentadol IR for each patient. Patients were then randomized in a 1:1 ratio to receive, during the first 2-week double-blind period, either the optimal dose of tapentadol IR identified during the open-label period or a TDD of tapentadol ER (100, 150, 200, or 250 mg bid) that was as close as possible to the TDD of tapentadol IR from the open-label period. During a subsequent, 2-week double-blind period, patients received whichever formulation was not received during the first double-blind period. The primary endpoint was the mean average daily pain intensity (on an 11-point numerical rating scale) during the last 3 days of each double-blind treatment period. If the 95% confidence intervals (CIs) of the least squares mean difference between formulations were within the range of −2 to 2, the formulations were considered equivalent. Results: Of the 88 patients who were randomized, 72 completed both double-blind treatments, and 60 were included in the per-protocol analysis. The mean (standard deviation [SD]) pain intensity score decreased from 7.3 (1.19) pre-treatment to 4.2 (2.13) after 3 weeks of open-label treatment with tapentadol IR and remained constant throughout double-blind treatment (3.9 or 4.0 each week) for both formulations. The mean (SD) of the average pain intensity scores over the last 3 days of double-blind treatment was 3.9 (2.17) with tapentadol IR and 4.0 (2.29) with tapentadol ER, for an estimated difference of 0.1 (95% CI, −0.09 to 0.28). For both tapentadol IR and tapentadol ER, the median TDD administered was 300.0 mg, and acetaminophen was used by 39.5% and 45.2% of patients, respectively. The incidence of treatment-emergent adverse events during double-blind treatment was similar between the tapentadol IR and tapentadol ER groups. Limitations: Use of rescue medication theoretically could have influenced pain measurements, but in practice, pain measurements did not differ between treatments. Conclusions: Approximately equivalent TDDs of tapentadol IR and tapentadol ER provided equivalent analgesic efficacy for the relief of moderate to severe chronic low back pain and were similarly well tolerated, allowing for direct conversion between the 2 formulations. Key words: Chronic low back pain, conversion, efficacy, equivalence, extended release, immediate release, opioid, safety, tapentadol

Download Full-text

Perbedaan Kemandirian Activity Of Daily Living Antara Penderita Low Back Pain Intensitas Nyeri Ringan Dengan Penderita Low Back Pain Intensitas Nyeri Sedang Di Desa Sobokerto Kecamatan Ngemplak Kabupaten Boyolali

Jurnal Keterapian Fisik ◽

10.37341/jkf.v1i1.66 ◽

2016 ◽

Vol 1 (1) ◽

Author(s):

Wawan Ridwan Mutaqin ◽

Rina Kurnia

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Rating Scale ◽

The Body ◽

P Value ◽

Back Side ◽

Low Back ◽

Moderate Pain ◽

Cross Sectional

Abstract: Low Back Pain, Pain Intensity, ADL Independency Level. The research aimed to reveal the dissimilarity of ADL independency on people with lower back pain (LBP) which varied from mild to moderate pain intensity. LBP means continuous pain which persists on the back side of the body span from lower ribs bone to coccyx bone and expand from upper back to the crotch. The research was comparing the level of independency in people with varied LBP intensity. The research conducted in Sobokerto, Ngemplak, Boyolali involving 50 respondents consisted of 25 respondents with mild pain intensity and 25 respondents with moderate pain intensity. Numeric Rating Scale (NRS) used as the research instrument to measure pain intensity and Barthel Index used as the tool to measure ADL independency level. The research designed is cross sectional and Mann Whitney U were used as the analytical method. The data were analyzed with the use of SPSS 16 for windows. P value obtained as 0.000 (< 0.05) troughs the analytical test of Mann Whitney U. The research depicts clear evidence of different level on performing ADL independency in people with LBP within mild and moderate pain intensity.

Download Full-text

Clinically significant changes in pain along the Pain Intensity Numerical Rating Scale in patients with chronic low back pain

PLoS ONE ◽

10.1371/journal.pone.0229228 ◽

2020 ◽

Vol 15 (3) ◽

pp. e0229228 ◽

Cited By ~ 3

Author(s):

Hidenori Suzuki ◽

Shuichi Aono ◽

Shinsuke Inoue ◽

Yasuaki Imajo ◽

Norihiro Nishida ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Chronic Low Back Pain ◽

Rating Scale ◽

Numerical Rating Scale ◽

Low Back ◽

Numerical Rating ◽

Clinically Significant

Download Full-text

Efficacy of the McKenzie Method in Patients With Chronic Nonspecific Low Back Pain: A Protocol of Randomized Placebo-Controlled Trial

Physical Therapy ◽

10.2522/ptj.20140208 ◽

2015 ◽

Vol 95 (2) ◽

pp. 267-273 ◽

Cited By ~ 8

Author(s):

Alessandra Narciso Garcia ◽

Lucíola da Cunha Menezes Costa ◽

Mark J. Hancock ◽

Matheus Oliveira de Almeida ◽

Fabrício Soares de Souza ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Low Back ◽

Numerical Rating ◽

Mckenzie Method ◽

And Function

Background The McKenzie method is widely used as an active intervention in the treatment of patients with nonspecific low back pain. Although the McKenzie method has been compared with several other interventions, it is not yet known whether this method is superior to placebo in patients with chronic low back pain. Objective The purpose of this trial is to assess the efficacy of the McKenzie method in patients with chronic nonspecific low back pain. Design An assessor-blinded, 2-arm, randomized placebo-controlled trial will be conducted. Setting This study will be conducted in physical therapy clinics in São Paulo, Brazil. Participants The participants will be 148 patients seeking care for chronic nonspecific low back pain. Intervention Participants will be randomly allocated to 1 of 2 treatment groups: (1) McKenzie method or (2) placebo therapy (detuned ultrasound and shortwave therapy). Each group will receive 10 sessions of 30 minutes each (2 sessions per week over 5 weeks). Measurements The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6, and 12 months after randomization. The primary outcomes will be pain intensity (measured with the Pain Numerical Rating Scale) and disability (measured with the Roland-Morris Disability Questionnaire) at the completion of treatment. The secondary outcomes will be pain intensity; disability and function; kinesiophobia and global perceived effect at 3, 6, and 12 months after randomization; and kinesiophobia and global perceived effect at completion of treatment. The data will be collected by a blinded assessor. Limitations Therapists will not be blinded. Conclusions This will be the first trial to compare the McKenzie method with placebo therapy in patients with chronic nonspecific low back pain. The results of this study will contribute to better management of this population.

Download Full-text

Effects of bridging and V-sitting exercises on pain intensity and disability of patients with non-specific chronic low-back pain

European Journal of Clinical and Experimental Medicine ◽

10.15584/ejcem.2021.2.4 ◽

2021 ◽

Vol 19 (2) ◽

pp. 137-144

Author(s):

Adesola O. Ojoawo ◽

◽

Abdullai A. Igbemo ◽

Timothy Adeyemi ◽

Matthew OB. Olaogun ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Chronic Low Back Pain ◽

Rating Scale ◽

Exercise Group ◽

Low Back ◽

Pain Disability ◽

Alpha Level ◽

Disability Questionnaire

Introduction. Exercises are important in the management of non-specific chronic low-back pain (NSCLBP). Aim. The study compared the effects of bridging and V-sitting exercises on pain and disability of patients with NSCLBP. Material and methods. 34 patients with NSCLBP recruited for the study were allocated into V-sitting (VSG) and Bridging Exercise group (BEG) equally. Participants in VSG and BEG groups performed V-sitting and bridging exercises respectively for 10 seconds, three times in a week for three weeks under a supervision of one of the authors. Each participants underwent ten sessions per a treatment regimen. Pain intensity and disability were assessed at the pre-intervention, second and third weeks using verbal rating scale and Rolland Morris Low Back Pain Disability Questionnaire prospectively. Data were analyzed using descriptive and inferential statistics, alpha level was set at 0.05 Results. There was a significant reduction in the third week (P < 0.001) in both VSG and BEG group of pain intensity and disability comparing the pre intervention, second and third week values. There was a significant reduction in the 3rd week VSG’s pain intensity (F=27.34 P<0.001) and disability (F=14.96, P<0.001) compared with BEG. Conclusion. V-sitting and bridging exercises were effective in management of patients with NSCLP, but V-sitting seems more effective.

Download Full-text

Efficacy of Tapentadol ER for Managing Moderate to Severe Chronic Pain

January 2018 - Pain Physician ◽

10.36076/ppj.2013/16/27 ◽

2013 ◽

Vol 1;16 (1;1) ◽

pp. 27-40 ◽

Cited By ~ 6

Author(s):

Marc Afilalo

Keyword(s):

Chronic Pain ◽

Low Back Pain ◽

Back Pain ◽

Knee Pain ◽

Tolerability Profile ◽

Low Back ◽

Phase 3 ◽

Osteoarthritis Pain ◽

Osteoarthritis Knee ◽

One Year

Background: Chronic non–cancer-related pain affects a large proportion of the adult population and is often difficult to manage effectively. Although opioid analgesics have been used to relieve chronic pain of different etiologies, opioids are associated with a range of side effects that may reduce patient quality of life and lead to reduced compliance with treatment.Tapentadol is a centrally acting analgesic with 2 mechanisms of action, µ-opioid receptor agonism and norepinephrine reuptake inhibition, that is available in an extended-release formulation for the management of chronic pain. Objective: To review the efficacy of tapentadol extended release (ER) for the management of moderate to severe chronic nociceptive and neuropathic pain. Methods: Efficacy results are summarized for four 15-week phase 3 studies of tapentadol ER in patients with moderate to severe chronic osteoarthritis knee pain (2 studies; ClinicalTrials.gov Identifiers: NCT00421928 and NCT00486811), low back pain (NCT00449176), and pain related to diabetic peripheral neuropathy (DPN; NCT00455520); a one-year phase 3 study of tapentadol ER in patients with moderate to severe chronic osteoarthritis pain or low back pain (NCT00361504); and a pooled analysis of data from the 15-week studies in patients with osteoarthritis knee pain or low back pain. A summary of the comparative tolerability for tapentadol ER and the active comparator used in these studies, oxycodone controlled release (CR), is provided. Results: Results of these studies showed that tapentadol ER (100 - 250 mg bid) was effective for the management of moderate to severe chronic osteoarthritis knee pain, low back pain, and pain related to DPN. Tapentadol ER (100 - 250 mg bid) has been shown to provide comparable pain relief to oxycodone HCl CR (20 - 50 mg bid) for chronic osteoarthritis knee pain and low back pain over up to one year of treatment. Tapentadol ER (100 - 250 mg bid) was associated with an improved tolerability profile, particularly gastrointestinal tolerability profile, and with lower rates of treatment discontinuations and adverse event-related discontinuations compared with oxycodone HCl CR (50 - 250 mg bid) over up to one year of treatment in patients with osteoarthritis knee pain and low back pain. Limitations: Differences in the design and duration of these phase 3 studies may limit comparisons of the efficacy results; nevertheless, this summary of efficacy results demonstrates the broad efficacy of tapentadol ER for different types of nociceptive and neuropathic pain. Conclusions: Tapentadol ER (100 - 250 mg bid) is effective for moderate to severe osteoarthritis pain, low back pain, and pain related to DPN and provides efficacy similar to that of oxycodone HCl CR (20 - 50 mg bid) for patients with osteoarthritis and low back pain. Tapentadol ER treatment has been associated with better gastrointestinal tolerability and compliance with therapy than oxycodone CR, which suggests that tapentadol ER may be a better option for the long-term management of chronic pain. Key words: Chronic pain, tapentadol ER, osteoarthritis pain, low back pain, diabetic peripheral neuropathy, oxycodone CR, opioid, analgesic

Download Full-text

Six-month, open-label study of hydrocodone extended release formulated with abuse-deterrence technology: Safety, maintenance of analgesia, and abuse potential

Journal of Opioid Management ◽

10.5055/jom.2016.0326 ◽

2016 ◽

Vol 12 (2) ◽

pp. 139 ◽

Cited By ~ 4

Author(s):

Martin E. Hale, MD ◽

Yuju Ma, MS ◽

Richard Malamut, MD

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Pain Intensity ◽

Chronic Low Back Pain ◽

Extended Release ◽

Study Drug ◽

Dose Titration ◽

Controlled Study ◽

Low Back ◽

Open Label

Objective: To evaluate long-term safety, maintenance of analgesia, and aberrant drug-related behaviors of hydrocodone extended release (ER) formulated with CIMA® Abuse-Deterrence Technology.Design: Phase 3, multicenter, open-label extension.Setting: Fifty-six US centers.Patients: Adults with chronic low back pain completing a 12-week placebo-controlled study of abuse-deterrent hydrocodone ER were eligible. One hundred eighty-two patients enrolled and received ≥1 dose of study drug, 170 entered open-label treatment, and 136 completed the study.Interventions: Patients receiving hydrocodone ER in the 12-week, placebo-controlled study continued their previous dose unless adjustment was needed; those previously receiving placebo (n = 78) underwent dose titration/adjustment to an analgesic dose (15-90 mg every 12 hours). Patients received 22 weeks of open-label treatment.Main outcome measures: Safety: adverse events (AEs). Maintenance of analgesia: worst pain intensity (WPI) and average pain intensity (API) at each study visit. Aberrant drug behavior: study drug loss and diversion. Results: AEs were reported for 65/182 (36 percent) patients during dose titration/adjustment and 88/170 (52 percent) during open-label treatment. No treatment-related serious AEs were reported. There were no clinically meaningful trends in other safety assessments, including physical examinations and pure tone audiometry. One patient receiving hydrocodone ER 30 mg twice daily experienced a severe AE of neurosensory deafness that was considered treatment related. Mean WPI and API remained steady throughout open-label treatment. Six (3 percent) patients reported medication loss, and 5 (3 percent) reported diversion.Conclusions: Abuse-deterrent hydrocodone ER was generally well tolerated in patients with chronic low back pain, maintained efficacy, and was associated with low rates of loss and diversion.

Download Full-text

Efficacy of Mobile Health in Patients with Low Back Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials (Preprint)

10.2196/preprints.26095 ◽

2020 ◽

Author(s):

Mingrong Chen ◽

Tingting Wu ◽

Meina Lv ◽

Zongwei Fang ◽

Zhiwei Zeng ◽

...

Keyword(s):

Low Back Pain ◽

Back Pain ◽

Usual Care ◽

Pain Intensity ◽

Mobile Health ◽

Rating Scale ◽

Meta Analysis ◽

Numeric Rating Scale ◽

Cochrane Library ◽

Low Back

BACKGROUND Low back pain is one of the most common health problems and a main cause of disability, which imposes a great burden on patients. Mobile health (mHealth) affects many aspects of people's lives, and it has progressed rapidly, showing promise as an effective intervention for patients with low back pain. However, the efficacy of mHealth interventions for patients with low back pain remains unclear; thus, further exploration is necessary. OBJECTIVE The purpose of this study was to evaluate the efficacy of mHealth interventions in patients with low back pain, compared to usual care. METHODS We searched for studies published in English before October 2020 in PubMed, EMBASE, Web of Science, and the Cochrane Library. Two researchers independently scanned the literature, extracted data, and assessed the methodological quality of the included studies. We used RevMan 5.4 software to perform the meta-analysis. RESULTS A total of 10 studies with 1003 participant, met the inclusion criteria. The simultaneous use of mHealth and usual care showed a greater reduction in pain intensity than usual care alone, as measured by the Numeric Rating Scale (mean difference [MD] -0.85, 95% CI -1.29 to -0.40; P<.001), and greater efficacy in reducing disability, as measured by the Rolland-Morris Disability Questionnaire (MD -1.58, 95% CI -2.33 to -0.83; P<.001). CONCLUSIONS The simultaneous interventions of mHealth and usual care has greater efficacy than usual care alone in reducing pain intensity and disability in patients with low back pain.

Download Full-text