A randomized, open-label, multicenter trial comparing once-a-day AVINZA® (morphine sulfate extended-release capsules) versus twice-a-day OxyContin® (oxycodone hydrochloride controlled-release tablets) for the treatment of chronic, moderate to severe low back pain: Improved physical functioning in the ACTION trial

2007 ◽  
Vol 3 (1) ◽  
pp. 35 ◽  
Author(s):  
Richard L. Rauck, MD ◽  
Stephen A. Bookbinder, MD ◽  
Timothy R. Bunker, MD ◽  
Christopher D. Alftine, MD ◽  
Steven Gershon, MD ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Physical Functioning ◽  
Mental Component Summary ◽  
Extended Release ◽  
Bodily Pain ◽  
Multicenter Trial ◽  
Low Back ◽  
Once Daily ◽  
Evaluation Phase

This multicenter trial compared the efficacy, safety, and effect on quality of life and work limitation of once-daily extended-release morphine sulfate capsules (AVINZA9, A-MQD) and twice-daily controlled-release oxycodone HCl tablets (OxyContin9, O-ER) in subjects with chronic, moderate to severe low back pain. After randomization and a period of opioid dose titration, subjects (n = 266) underwent an eight-week evaluation phase and an optional four-month extension phase (n = 174 in extension phase). Subjects were assessed using the 12-item Short-Form Health Survey9 (SF-12) and the Work Limitations Questionnaire9 (WLQ). In both groups, significant improvements were observed in the SF-12 mean scores for physical functioning (p < 0.001), role physical (p < 0.0001), bodily pain (p < 0.0001), physical summary (p < 0.001), and mental component summary (p < 0.005). At the end of the titration period, greater relative improvements from baseline were seen in the SF-12 section on physical components in the A-MQD group versus the O-ER group, with significant differences observed for physical functioning (p = 0.0374), role physical (p = 0.0341), bodily pain (p = 0.0001), and physical summary (p = 0.0022). In both groups, SF-12 mean scores improved significantly for mental health (p < 0.01), role emotional (p < 0.01), social functioning (p < 0.0005), vitality (p < 0.005), and the mental component summary (p < 0.005), but no significant differences were noted between the two groups. Both groups reported improvement from baseline in WLQ physical demands scores, with no significant differences noted between the two groups. At the end of the evaluation phase, fewer subjects were unable to work due to illness or treatment in the A-MQD group than in the OER group (8.5percent versus 19.4percent, respectively; p = 0.0149). In conclusion, compared to twice-daily OxyContin, once-daily AVINZA resulted in significantly better and earlier improvement of physical function and ability to work.

scholarly journals A randomized, open-label study of once-a-day AVINZA® (morphine sulfate extended-release capsules) versus twice-a-day OxyContin® (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: The extension phase of the ACTION trial

2006 ◽  
Vol 2 (6) ◽  
pp. 325 ◽  
Author(s):  
Richard L. Rauck, MD ◽  
Stephen A. Bookbinder, MD ◽  
Timothy R. Bunker, MD ◽  
Christopher D. Alftine, MD ◽  
Richard Ghalie, MD ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Extended Release ◽  
Extension Phase ◽  
Low Back ◽  
Open Label ◽  
Pain Scores ◽  
Evaluation Phase ◽  
Morphine Equivalent

Study design and objective: The ACTION ® trial, an open-label, randomized, multicenter, two-part study, compared the efficacy and safety of two sustained-release opioids (SROs), AVINZA (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin® (O-ER), oxycodone modified-release tablets given twice a day, in subjects with chronic, moderate to severe low back pain. The first part of the study, the evaluation phase, was followed by an optional four-month extension phase aimed at evaluating the long-term stability of pain control, SRO dose, and quality of sleep.Results: Three hundred and ninety-two subjects were enrolled in the study; 220 completed the evaluation phase, and 174 entered the extension phase. During the latter phase, subjects in the A-MQD group (n = 79) continued to report lower pain scores, better quality of sleep, lower daily morphine-equivalent doses (means of 86 mg versus 119 mg), and a comparable usage of ibuprofen compared to subjects in the O-ER group (n = 95). The incidence and severity of elicited opioid side effects were similar between the two groups.Conclusions: Both study drugs resulted in significant pain relief and improved sleep in SRO-naive patients with chronic low back pain, and this outcome was attained with a stable daily SRO dose. In patients who completed opioid dose titration, AVINZA performed significantly better than OxyContin in reducing pain scores and improving sleep—with a lower morphine-equivalent daily dose—during both the evaluation and extension phases.

The ACTION study: A randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA®) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin®) for the treatment of chronic, moderate to severe low back pain

2006 ◽  
Vol 2 (3) ◽  
pp. 155 ◽  
Author(s):  
Richard L. Rauck, MD ◽  
Stephen A. Bookbinder, MD ◽  
Timothy R. Bunker, MD ◽  
Christopher D. Alftine, MD ◽  
Richard Ghalie, MD ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Control ◽  
Extended Release ◽  
Morphine Sulfate ◽  
Dose Titration ◽  
Low Back ◽  
Open Label ◽  
Opioid Dose ◽  
Evaluation Phase

This large, open-label, randomized, parallel-group, multicenter study compared two oral sustained-release opioids (SROs)—AVINZA® (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin® (O-ER), oxycodone modified-release tablets given twice a day—in SRO-naive subjects ages 30 to 70 with chronic, moderate to severe low back pain. Of the 392 subjects enrolled and randomized, 266 (132 in the AMQD group and 134 in the O-ER group) completed the opioid dose titration phase and entered an eight-week evaluation phase. During the evaluation phase, A-MQD achieved significantly better pain control than O-ER, as demonstrated by a greater decrease from baseline in pain scores obtained four times daily during weeks one, four, and eight (p = 0.002). The number of breakthrough-pain rescue medication doses adjusted for the number of patient days was significantly lower in the A-MQD group (p < 0.0001). Better pain control with A-MQD was achieved with a significantly lower daily opioid dose than with O-ER (mean 69.9 mg and 91 mg morphine equivalents, respectively; p = 0.0125). Quality of sleep was significantly better with A-MQD for the entire evaluation phase (p = 0.0026). The incidence and severity of elicited opioid side effects were similar in the two groups. This trial demonstrated that once-daily A-MQD provides consistent around-the-clock pain relief in patients with low back pain. In patients who completed opioid dose titration, A-MQD was significantly better than O-ER for reducing pain and improving sleep, while requiring a lower daily opioid dose.

scholarly journals Implementation of Clinical Guidelines on Physical Therapy for Patients With Low Back Pain: Randomized Trial Comparing Patient Outcomes After a Standard and Active Implementation Strategy

2005 ◽  
Vol 85 (6) ◽  
pp. 544-555 ◽  
Author(s):  
Geertruida E Bekkering ◽  
Maurits W van Tulder ◽  
Erik JM Hendriks ◽  
Marc A Koopmanschap ◽  
Dirk L Knol ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Physical Therapy ◽  
Patient Outcomes ◽  
Physical Functioning ◽  
Clinical Guidelines ◽  
Physical Therapists ◽  
Low Back ◽  
Active Strategy ◽  
Active Implementation

Abstract Background and Purpose. An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain. The effect of this strategy on patients' physical functioning, coping strategy, and beliefs regarding their low back pain was studied. Subjects. One hundred thirteen primary care physical therapists treated a total of 500 patients. Methods. The physical therapists were randomly assigned to 1 of 2 groups. The control group received the guidelines by mail (standard passive method of dissemination). The intervention group, in contrast, received an additional active training strategy consisting of 2 sessions with education, group discussion, role playing, feedback, and reminders. Patients with low back pain, treated by the participating therapists, completed questionnaires on physical functioning, pain, sick leave, coping, and beliefs. Results. Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks. Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up. Discussion and Conclusion. The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain. Active implementation strategies are not recommended if patient outcomes are to be improved.

scholarly journals Adherence to Clinical Practice Guidelines for Low Back Pain in Physical Therapy: Do Patients Benefit?

2010 ◽  
Vol 90 (8) ◽  
pp. 1111-1122 ◽  
Author(s):  
Geert M. Rutten ◽  
Saskia Degen ◽  
Erik J. Hendriks ◽  
Jozé C. Braspenning ◽  
Janneke Harting ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Physical Therapy ◽  
Physical Functioning ◽  
Guideline Adherence ◽  
Internal Validity ◽  
Small Sample ◽  
Low Back ◽  
Process Of Care ◽  
Dutch Version

BackgroundVarious guidelines for the management of low back pain have been developed to enhance the effectiveness and efficiency of care. Evidence that guideline-adherent care results in better health outcomes, however, is not conclusive.ObjectiveThe main objective of this study was to assess whether a higher percentage of adherence to the Dutch physical and manual therapy guidelines for low back pain is related to improved outcomes. The study further explored whether this relationship differs for the individual steps of the process of care and for distinct subgroups of patients.DesignThis was an observational prospective cohort study (2005–2006) in the Netherlands that included a sample of 61 private practice therapists and 145 patients.MethodsTherapists recorded the process of care and the number of treatment sessions in Web-based patient files. Guideline adherence was assessed using quality indicators. Physical functioning was measured by the Dutch version of the Quebec Back Pain and Disability Scale, and average pain was measured with a visual analog scale. Relationships between the percentage of guideline adherence and outcomes of care were evaluated with regression analyses.ResultsHigher percentages of adherence were associated with fewer functional limitations (β=−0.21, P=.023) and fewer treatment sessions (β=−0.27, P=.005).LimitationsThe relatively small self-selected sample might limit external validity, but it is not expected that the small sample greatly influenced the internal validity of the study. Larger samples are required to enable adequate subgroup analyses.ConclusionsThe results indicate that higher percentages of guideline adherence are related to better improvement of physical functioning and to a lower utilization of care. A proper assessment of the relationship between the process of physical therapy care and outcomes may require a comprehensive set of process indicators to measure guideline adherence.

scholarly journals Tapentadol Extended Release in the Treatment of Severe Chronic Low Back Pain and Osteoarthritis Pain

2018 ◽  
Vol 7 (1) ◽  
pp. 37-57 ◽  
Author(s):  
Joseph V. Pergolizzi ◽  
Robert Taylor ◽  
Jo Ann LeQuang ◽  
Robert B. Raffa ◽  
John Bisney
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Chronic Low Back Pain ◽  
Extended Release ◽  
Low Back ◽  
Osteoarthritis Pain

Longer-Term Clinical and Economic Benefits of Offering Acupuncture to Patients with Chronic Low Back Pain Assessed as Suitable for Primary Care Management – 3 Month Clinical Outcomes from a Controlled Trial of 241 Patients

2002 ◽  
Vol 20 (2-3) ◽  
pp. 121-137
Author(s):  
H Macpherson ◽  
K Thomas ◽  
J Brazier ◽  
M Fitter ◽  
L Thorpe ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Control Group ◽  
Low Back ◽  
Randomised Controlled ◽  
Pragmatic Randomised Controlled Trial

Objectives To undertake a pragmatic randomised controlled trial to test the hypothesis that a population of patients with persistent low back pain, when given access to an acupuncture service, gain more relief from pain than those offered usual management only, for equal or less cost. Methods The study is a pragmatic randomised controlled trial (n=241). Suitable patients are identified by their general practitioners. Patients randomised to the experimental arm are offered the option of referral for up to 10 individualised treatments from one of six qualified acupuncture practitioners. The control group continues to receive usual management from their general practitioner. The primary scale used for measuring change is the Bodily Pain (SF–36) at 3 months and 12 months post randomisation. The main outcome is cost-effectiveness at 12 months. Results A total of 43 general practitioners participated in the trial and 241 patients were randomised. All patients randomised to the option of acupuncture chose to receive treatment. Clinical outcomes at 3 months show that the SF-36 Bodily Pain scores improved by 29.4 and 24.9 points in the acupuncture and normal management group respectively (p=0.125). Patients in the acupuncture group reported lower levels of worry at three months (p<0.001). Conclusions It is possible to conduct a large pragmatic randomised controlled trial of acupuncture in a primary care setting. Acupuncture is seen as an acceptable treatment by patients with low back pain. Clinical outcomes at three months suggest that the acupuncture group are in less pain than the control group.

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