Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy

BACKGROUND: Painful neuropathy is one of the most common long-term complications of diabetes mellitus and often proves difficult to relieve.METHODS: Patients with diabetic neuropathy with moderate or greater pain for at least 3 months, were evaluated for efficacy, safety and health-related quality of life (QOL) while receiving controlled-release (CR) oxycodone (OxyContin) or active placebo. Patients underwent washout from all opioids 2-7 days before randomization to 10 mg CR oxycodone or active placebo (0.25 mg benztropine) q12h. The dose was increased, approximately weekly, to a maximum of 40 mg q12h CR oxycodone or 1 mg q12h benztropine, with crossover to the alternate treatment after a maximum of 4 weeks. Acetaminophen, 325-650 mg q4-6h prn was provided as rescue.RESULTS: Thirty-six patients were evaluable for efficacy (21 men, 15 women, mean age 63.0+/-9.4 years). CR oxycodone resulted in significantly lower (P=0.0001) mean daily pain (21.8+/-20.7 vs. 48.6+/-26.6 mm VAS), steady pain (23.5+/-23.0 vs. 47.6+/-30.7 mm VAS), brief pain (21.8+/-23.5 vs. 46.7+/-30.8 mm VAS), skin pain (14.3+/-20.4 vs. 43.2+/-31.3 mm VAS), and total pain and disability (16.8+/-15.6 vs. 25.2+/-16.7; P=0.004). Scores from 6 of the 8 SF-36 domains and both summary scales, Standardized Physical Component (P=0.0002) and Standardized Mental Component (P=0.0338) were significantly better during CR oxycodone treatment. The number needed to treat to obtain one patient with at least 50% pain relief is 2.6 and clinical effectiveness scores favoured treatment with CR oxycodone over placebo (P=0.0001).CONCLUSION: CR oxycodone is effective and safe for the management of painful diabetic neuropathy and improves QOL.     

Acupuncture for treatment of persistent arm pain due to repetitive use: a randomized controlled clinical trial

OBJECTIVE: To compare true and sham acupuncture in their abilities to relieve arm pain and improve arm function in individuals with arm pain due to repetitive use. METHODS: Participants with persistent arm pain (N=123) were randomly assigned to true or sham acupuncture groups and received 8 treatments over 4 weeks. The primary outcome was intensity of pain (10-point scale) and secondary outcomes were arm symptoms, arm function, and grip strength. Outcomes were measured during treatment (at 2 and 4 wk) and 1 month after treatment ended. RESULTS: Arm pain scores improved in both groups during the treatment period, but improvements were significantly greater in the sham group than in the true acupuncture group. This difference disappeared by 1 month after treatment ended. The true acupuncture group experienced more side effects, predominantly mild pain at time of treatments. DISCUSSION: Sham acupuncture reduced arm pain more than true acupuncture during treatment, but the difference did not persist after 1 month. Mild side effects from true acupuncture may have blunted any positive treatment effects. Overall, this study did not find evidence to support the effectiveness of true acupuncture in treatment of persistent arm pain due to repetitive use.     

Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial

Chronic osteoarthritis (OA) pain of the knee is often not effectively managed with current non-pharmacological or pharmacological treatments. Radiofrequency (RF) neurotomy is a therapeutic alternative for chronic pain. We investigated whether RF neurotomy applied to articular nerve branches (genicular nerves) was effective in relieving chronic OA knee joint pain. The study involved 38 elderly patients with (a) severe knee OA pain lasting more than 3 months, (b) positive response to a diagnostic genicular nerve block and (c) no response to conservative treatments. Patients were randomly assigned to receive percutaneous RF genicular neurotomy under fluoroscopic guidance (RF group; n = 19) or the same procedure without effective neurotomy (control group; n = 19). Visual analogue scale (VAS), Oxford knee scores, and global perceived effect on a 7-point scale were measured at baseline and at 1, 4, and 12 weeks post-procedure. VAS scores showed that the RF group had less knee joint pain at 4 (p < 0.001) and 12 (p < 0.001) weeks compared with the control group. Oxford knee scores showed similar findings (p < 0.001). In the RF group, 10/17 (59%), 11/17 (65%) and 10/17 (59%) achieved at least 50% knee pain relief at 1, 4, and 12 weeks, respectively. No patient reported a post-procedure adverse event during the follow-up period. RF neurotomy of genicular nerves leads to significant pain reduction and functional improvement in a subset of elderly chronic knee OA pain, and thus may be an effective treatment in such cases. Further trials with larger sample size and longer follow-up are warranted.     

Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial

OBJECTIVE: To compare the efficacy and safety of celecoxib, a cyclooxygenase-2 (COX-2) inhibitor, with those of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and placebo in the treatment of osteoarthritis of the knee. METHODS: In this multicenter, randomized, double-blind, placebo-controlled trial, 1003 patients with symptomatic osteoarthritis of the knee were randomly assigned to receive celecoxib at doses of 50, 100, or 200 mg twice a day; naproxen, 500 mg twice a day; or placebo for 12 weeks. Patients were evaluated with standard measures of efficacy 2 to 7 days after discontinuing previous NSAID or analgesic therapy and after 2, 6, and 12 weeks of treatment with the study drug. RESULTS: Celecoxib treatment led to significant improvement in the signs and symptoms of osteoarthritis as determined by all efficacy measures. Significant pain relief occurred within 2 days of the initiation of treatment, and maximum anti-inflammatory and analgesic activity, evident within 2 weeks, was sustained throughout the 12-week study. All celecoxib doses were efficacious compared with placebo, although the 50-mg twice-daily dosage regimen was minimally effective. The higher doses of celecoxib (100 and 200 mg twice a day) were similarly efficacious, and the magnitude of improvement observed with these dosing regimens was comparable to that seen with naproxen at a dose of 500 mg twice a day. All doses of celecoxib and naproxen were well tolerated. CONCLUSION: COX-2 inhibition with celecoxib is an effective approach for the treatment of osteoarthritis, as seen by clinical improvement in signs and symptoms comparable to treatment with naproxen.     

Impact of controlled-release oxycodone on efficacy beliefs and coping efforts among osteoarthritis patients with moderate to severe pain

OBJECTIVES: This study examines the impact of controlled-release oxycodone (OxyContin) on cognitive-behavioral indicators of efficacy beliefs and coping efforts in patients with osteoarthritis who experience persistent pain. METHODS: This was a double-blind, placebo-controlled study of 104 male and female patients with osteoarthritis who experienced moderate to severe pain. Pain assessment, arthritis helplessness, and coping efforts were assessed before and after for treatment and placebo control groups. RESULTS: Examination of differences between treatment and control groups after 2 weeks revealed significant reductions in reported pain, improvements in coping efficacy, and reductions in helplessness and passive coping in response to controlled-release oxycodone treatment compared to placebo. Changes in pain partially mediated the effects on coping in subsequent assessments. DISCUSSION: The findings indicate that controlled-release oxyco- done treatment accounted for improvements in coping with pain beyond that of placebo controls. This medication may be most beneficial to osteoarthritis patients when incorporated as part of a multidisciplinary approach to pain management.     

盐酸羟考酮控释片治疗老年癌痛体会

目的 观察盐酸羟考酮控释片(商品名:奥施康定),治疗老年恶性肿瘤患者中、重度疼痛的临床效果及不良反应,明确该药在治疗老年癌痛中的有效性及安全性.方法 2005年3月至2009年2月中、重度疼痛老年恶性肿瘤患者(年龄≥60岁)106例,给予盐酸羟考酮控释片镇痛治疗,初始剂量10 mg/12 h,正在用吗啡类镇痛药者,按照口服吗啡1/2剂量换算,根据疼痛情况调整剂量,直至患者无痛或基本无痛,每位患者至少治疗4周以上.同时进行疼痛强度、睡眠、食欲、疲乏、精神状态、日常生活、理解配合程度评分及不良反应观察.结果 盐酸羟考酮控释片在老年癌痛患者最小有效剂量为10 mg/d,每日剂量≥200 mg的23例(21.7%),100～180 mg/d的30例(28.2%),10～90 mg/d的53例(50.0%).疼痛缓解率为97.2%,不良反应主要表现为消化道反应(便秘、恶心和呕吐),便秘较常见,需要药物干预者26例(24.53%).结论 盐酸羟考酮控释片治疗老年中、重度癌性疼痛疗效显著,耐受性良好,不良反应较少,能很好地改善老年癌症患者的生活质量.     

Effects of a foot-ankle muscle strengthening program on pain and function in individuals with knee osteoarthritis: a randomized controlled trial

BackgroundFoot-ankle exercises could improve pain and function of individuals with KOA and need to be tested.ObjectiveTo investigate whether an 8-week foot-ankle muscle strengthening program is effective for individuals with KOA to reduce pain and improve function.MethodsIn this randomized controlled trial, individuals diagnosed with clinical and radiographic KOA were randomized into the intervention (supervised foot-ankle strengthening exercise program three times a week for 8 weeks) or control (usual care and recommendations of the healthcare team) group. Effectiveness was assessed by changes in clinical and functional outcomes between baseline and 8 weeks with pain as the primary outcome. ANCOVA tests using the intervention group as a reference and sex, body mass index, and baseline values as covariates assessed between-group differences.ResultsThe intervention group showed lower pain scores (−4.4 units; 95%CI = −7.5, −1.1), better function (−7.1 units; 95%CI = −12.7, −1.4), higher total functional score (−11.9 units; 95%CI = −20.7, −3.1), with confidence intervals indicating a potential for the differences to be clinically meaningful, and better scores for the 30-s chair stand test (2.7 repetitions; 95%CI = 1.1, 4.1), with a confidence interval indicating a moderate clinically meaningful difference, compared to the controls.ConclusionThe 8-week foot-ankle exercise program showed positive, and potentially clinically meaningful, effects on knee pain and physical function among individuals with KOA, when compared to usual care.Trial registrationNCT04154059. https://clinicaltrials.gov/ct2/show/NCT04154059     

Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study.

Controlled-release oral formulations of oxycodone and morphine are both suitable analgesics for moderate to severe pain. They were compared in cancer-pain patients randomized to double-blind treatment with controlled-release oxycodone (n = 48) or controlled-release morphine (n = 52) every 12 h for up to 12 days. Stable analgesia was achieved by 83% of controlled-release oxycodone and 81% of controlled-release morphine patients in 2 days (median). Following titration to stable analgesia, pain intensity (0=none to 3=severe) decreased from baseline within each group (p 相似文献   

Radial nerve mobilization decreases pain sensitivity and improves motor performance in patients with thumb carpometacarpal osteoarthritis: a randomized controlled trial

Villafañe JH, Silva GB, Bishop MD, Fernandez-Carnero J. Radial nerve mobilization decreases pain sensitivity and improves motor performance in patients with thumb carpometacarpal osteoarthritis: a randomized controlled trial.ObjectiveTo examine the effects of radial nerve mobilization on pain sensitivity and motor performance in subjects with secondary thumb carpometacarpal osteoarthritis.DesignRandomized controlled trial. Treatment and placebo were given for 4 weeks. Measurements were taken before intervention, after 1 month (first follow-up), and after 2 months (second follow-up).SettingPatients from the Department of Physical Therapy, Azienda Sanitaria Locale 3, Collegno (Italy).ParticipantsParticipants (N=60; age range, 70–90y) with right-dominant hand secondary thumb carpometacarpal osteoarthritis without other motor-related pathology. All patients completed the study. No patients were withdrawn from the study.InterventionsSliding mobilization of the proximal-distal radial nerve or intermittent ultrasound therapy, used as placebo.Main Outcome MeasuresWe hypothesized that radial nerve mobilization induces hypoalgesia and increases strength in secondary thumb carpometacarpal osteoarthritis. We measured pressure pain threshold (PPT) at the trapeziometacarpal joint, the tubercle of the scaphoid bone, and the unciform apophysis of the hamate bone by algometry. Tip pinch strength and tripod pinch strength were measured by a mechanical pinch gauge.ResultsTreatment increased PPT by 3.33±.24kg/cm² (P<.001) in the trapeziometacarpal joint and was maintained until first follow-up and second follow-up. Also, PPT in the scaphoid bone and hamate bone was increased (P<.001 and P<.02, respectively). Variables in the placebo group remained unchanged. Tip pinch strength increased by 2.22±.22kg (P<.04) and tripod pinch strength by 2.83±.24kg (P<.019).ConclusionsRadial nerve mobilization decreases pain sensitivity in the trapeziometacarpal joint and increases tip pinch strength.     

Efficacy and safety of controlled-release versus immediate-release oxycodone: randomized, double-blind evaluation in patients with chronic back pain.

OBJECTIVE: To compare the efficacy and safety of controlled-release oxycodone given every 12 hours with immediate-release oxycodone given four times daily in patients with persistent back pain. DESIGN: Randomized, double-blind, active-controlled, two-period crossover trial. PATIENTS: Fifty-seven adult outpatients with stable, chronic, moderate-to-severe low back pain despite analgesic therapy were enrolled; 47 were randomized; 11 discontinued for side effects, most commonly nausea and vomiting. INTERVENTIONS: Controlled-release oxycodone tablets given every 12 hours; immediate-release oxycodone tablets given four times daily; dose titration with controlled-release or immediate-release for up to 10 days; double-blind treatment for 4-7 days each. OUTCOME MEASURES: Patients' pain scores (0 = none, 1 = slight, 2 = moderate, 3 = severe). RESULTS: Pain intensity decreased from moderate to severe at baseline to slight at the end of titration with both oxycodone formulations. The daily oxycodone dose was 40 mg or less in 68% of patients. During double-blind treatment, mean pain intensity was maintained at 1.2 (0.1 SE) with controlled-release and at 1.1 (0.1 SE) with immediate-release oxycodone. The most common adverse events were constipation, nausea, pruritus, somnolence, and dizziness. CONCLUSIONS: Controlled-release oxycodone given every 12 hours was comparable with immediate-release oxycodone given four times daily in efficacy and safety, and it provides convenient, twice-daily, around-the-clock treatment for selected patients with persistent back pain that is inadequately controlled by nonopioids or as-needed opioid therapy.     

Program of therapeutic exercises associated with electrotherapy in patients with chronic neck pain: Protocol for a randomized controlled trial

Conservative treatment is the most common clinical management for the proper rehabilitation of patients with chronic neck pain, and there is a trend towards the use of therapeutic exercise. However, some uncertainty about the efficacy of therapeutic exercises remains, and it is necessary to conduct more studies with high methodological rigor, especially in regard to multimodal treatment, as in the combination of therapeutic exercises with electrotherapy. Thus, the objective of this study will be to evaluate the clinical effects of adding high- and low-frequency transcutaneous electrical nerve stimulation (TENS) in a program of specific therapeutic exercises for the treatment of patients with chronic neck pain. Sixty participants will be randomized into three groups: therapeutic exercise + placebo TENS group (n = 20), therapeutic exercise + high-frequency TENS group (n = 20), and therapeutic exercise + low-frequency TENS group (n = 20). Eight treatment sessions will be performed, and participants will be evaluated before and after the eight sessions and four weeks after the end of treatment. The Numerical Rating Pain Scale, Neck Disability Index, Pain-Related Catastrophizing Thoughts Scale, and Tampa Scale for Kinesiophobia will be used for participant evaluations. In the statistical analysis, a linear mixed model will be applied considering interaction between time and group factors. The addition of this electrotherapeutic modality to a therapeutic exercise program is expected to generate clinical improvements for patients with chronic neck pain, and if the results demonstrate benefits in the treatment group, this form of care could be used.     

Lamotrigine in spinal cord injury pain: a randomized controlled trial

The objective was to investigate the effectiveness of lamotrigine for the treatment of spinal cord injury pain and clinical signs of neuronal hyperexcitability. Thirty patients with spinal cord injury (SCI) and at or below level neuropathic pain participated in a randomized double blind, placebo-controlled, crossover trial. A 1-week baseline period was followed by two treatment periods of 9 weeks duration with lamotrigine slowly increased to a maximum of 400 mg or placebo separated by a 2-week washout period. The primary outcome measure was the change in median pain score from baseline week to the last week of treatment. Secondary outcome measures included thresholds to standardized sensory stimuli using quantitative sensory testing. Twenty-two patients completed the trial. We found no statistically significant effect of lamotrigine as evaluated in the total sample. However, in patients with incomplete SCI, lamotrigine significantly reduced pain at or below SCI level. Patients with brush evoked allodynia and wind-up-like pain in the area of maximal pain were more likely to have a positive effect to lamotrigine than patients without these evoked pains (7 of 7 vs. 1 of 14). Lamotrigine was generally well tolerated. While this trial showed no significant effect on spontaneous and evoked pain in complete and incomplete spinal cord injury, lamotrigine reduced spontaneous pain in patients with incomplete spinal cord injury and evoked pain in the area of spontaneous pain.     

主动运动与推拿治疗非特异性下腰痛:临床随机对照

目的:主动运动和中医推拿被广泛用于腰痛的治疗,比较主动运动和中医推拿对随机就诊非特异性下腰痛患者的疼痛程度和日常生活活动功能的影响。方法:实验于1996-01/1998-12在阿曼马斯喀特亚洲医学中心完成。189例非特异性下腰痛患者按就诊顺序随机分成A组(137例)主动运动加推拿治疗;B组(52例)按摩治疗;治疗前后用疼痛模拟量尺(visualanalogscale,VAS)和Oswestry腰痛残疾问卷量表Oswestrylow(backpaindisabilityindex,OSW,评定两组患者的疼痛程度和日常生活)活动受限程度。结果:A,B两组VAS和OSW指数都有下降,A组VAS指数下降明显大于B组(t=2.657,P<0.01);A组OSW指数下降亦明显大于B组(t=15.733,P<0.01)。6个月～2年随访表明A组复发率15.08%(19/126)低于B组35.42%17/48),经检验χ2=8.761,P<0.01。(结论:主动运动和按摩治疗均可减轻疼痛、改善日常生活活动功能。主动运动有利于预防复发,运动疗法是经济有效的治疗腰痛方法。     

Nurse practitioners can effectively deliver pain coping skills training to osteoarthritis patients with chronic pain: A randomized,controlled trial

A multisite, randomized, controlled clinical effectiveness trial was conducted for osteoarthritis patients with chronic pain of the knee or hip. Adult health nurse practitioners provided a 10-session intervention, pain coping skills training (PCST), in patients’ doctors’ offices (N = 129 patients); the control group received usual care (N = 127 patients). Primary outcomes assessed at baseline, posttreatment, 6-month follow-up, and 12-month follow-up were: pain intensity, physical functioning, psychological distress, self-efficacy, catastrophizing, use of coping strategies, and quality of life. Secondary measures included fatigue, social functioning, health satisfaction, and use of pain medication. Methods favoring external validity, consistent with pragmatic, effectiveness research, were utilized. Primary ITT and secondary per-protocol analyses were conducted. Attrition was within the expected range: 11% at posttreatment and 29% at 12-month follow-up; rates did not differ between groups. Omnibus ITT analyses across all assessment points indicated significant improvement for the PCST group compared with the control group for pain intensity, physical functioning, psychological distress, use of pain coping strategies, and self-efficacy, as well as fatigue, satisfaction with health, and reduced use of pain medication. Treatment effects were robust to covariates (demographics and clinical sites). Trends in the outcomes across the assessments were examined. All outcomes, except for self-efficacy, were maintained through the 12-month follow-up; effects for self-efficacy degraded over time. Per-protocol analyses did not yield greater effect sizes. Comparisons of PCST patients who were more vs less treatment adherent suggested greater effectiveness for patients with high adherence. Results support the effectiveness of nurse practitioner delivery of PCST for chronic osteoarthritis pain.