Significant Improvement In Pain Intensity Research Articles

Osseofix® System for Percutaneous Stabilization of Osteoporotic and Tumorous Vertebral Compression Fractures – Clinical and Radiological Results After 12 Months

Determining whether implantation of an expandable titanium mesh cage (Osseofix® system) is a successful and safe minimally invasive therapy for osteoporotic and tumorous vertebral compression fractures (VCFs). 32 patients (25 women, 7 men, mean age 71) with 46 osteoporotic or tumorous VCFs (T6 to L4) from June 2010 to January 2012 were included. All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA). The clinical and radiological results were evaluated preop, postop and 12 months postop based on the visual analog scale (VAS) and the Oswestry Disability Index (ODI), X-ray (Beck Index, Cobb angle) and CT. There was a significant improvement in pain intensity (VAS) (7.8 to 1.6) as well as a significant reduction in the mean ODI (71.36 % to 30.4 %) after 12 months. The mean kyphotic angle according to Cobb showed significant improvements (12.3° to 10.8°) after 12 months. Postinterventional imaging showed one case of loss of height in a stabilized lumbar vertebral body (2.2 %) in osteoporosis and one case with adjacent fracture (2.2 %) in osteoporosis. We saw no changes in the posterior vertebral wall. Except for one pronounced postoperative hematoma, we saw no surgical complications including no cement leakage. The clinical mid-term results are good at a low complication rate. The stabilization of symptomatic osteoporotic and tumorous VCFs with the Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation. • The Osseofix® system is well suited for stabilizing osteoporotic and tumorous VCFs.• It is a safe and effective procedure without cement leakage and with a low complication rate.• The procedure is an interesting alternative to established cement augmentation procedures.

COMPARISON OF TWO MANUAL THERAPY TECHNIQUES ON PAIN AND FUNCTION IN SUBJECTS WITH NECK PAIN

Introduction: Neck pain is of the common musculoskeletal disorders. Physical maltreatment may have caused disability and socioeconomic repercussions. However, manual therapy techniques are less costly, with least side effects in treatment of neck pain, but there is a lack of evidence about the efficacy of these methods or a comparison of treatment to suggest the best technique. Materials and Methods: Thirty subjects with neck pain, aged 18-35 years old, were participated in this study. All individuals were randomly classified into two groups. One group received massage therapy and the other strain-counter strain technique. Participants had three therapy sessions every other day. Pain was accessed via pain numerical rating scale (PNRS) and neck disability index (NDI) questionnaire was used to measure the level of functional disability just before and immediately after each technique. Paired and sample t-tests were used to analyze the data. Results: There was a significant improvement in pain intensity and disability level after massage therapy (PNRS = 0.001, NDI = 0) and strain counter-strain (PNRS = 0, NDI = 0.03). Nevertheless no significant differences were found just after intervention in NDI between both groups (P > 0.05). Differences in NRS between both intervention groups were statistically found (P < 0.05). Conclusion: Both massage and Strain-Counter strain alleviate pain and improved function in patients with neck pain, although massage therapy was more effective in these patients. Keywords: Neck pain, Massage, Strain-Counter strain technique, Functional disability

PROPRIOCEPTIVE TRAINING AS AN ADJUNCT IN OSTEOARTHRITIS OF KNEE

Osteoarthritis (OA) is steadily becoming the most common cause of disability with advancing age. So, this study was aimed to prevent and rehabilitate the patient with such disability. Proprioception along with other deficits have been established with threat to the concerned joint. Hence, objective of the study was set to show the efficacy of proprioceptive training with conventional physiotherapy versus conventional physiotherapy. A Pre test- Post test single blind experimental study was designed with 44 patients having knee OA and randomly divided in two groups. Outcome measures were pain intensity on NRS, functional disability on Reduced WOMAC and joint position sense (JPS) error on Electronic Goniometer. Results between group comparisons showed significant improvement in pain intensity (p &lt; 0.05), WOMAC score (p &lt; 0.05) and JPS error (p &lt; 0.05). However both the groups improved significantly but there was more significant improvement in group with proprioception intervention. Hence, it can be concluded that proprioceptive training should be included along with conventional physiotherapy in knee OA rehabilitation.

Motivational interviewing and exercise programme for community‐dwelling older persons with chronic pain: a randomised controlled study

To examine the effectiveness of an integrated motivational interviewing and physical exercise programme on pain, physical and psychological function, quality of life, self-efficacy, and compliance with exercise for community-dwelling older persons with chronic pain. Chronic pain is common among older persons. Indeed, motivation for managing pain is poor, and may cause negative consequences. Motivational interviewing maybe effective in treating chronic pain. Single-blinded randomised control study. Older persons with chronic pain (n = 56) were recruited from two elderly community centres. They were blinded from the group allocation. The programme was conducted by an motivational interviewing-trained physiotherapist and registered nurses. Participants in the experimental group received an 8-week integrated motivational interviewing and physical exercise programme, while the control group received regular activities in the centre. Motivational interviewing used open-ended questions to encourage participants to express and recognise their pain and behaviours and professional feedback was given accordingly. Pain intensity, pain self-efficacy, anxiety, happiness, depression, mobility and quality of life were measured before and after the motivational interviewing and physical exercise programme. Attendance and compliance rate of the programme was calculated in the experimental group. Significant improvements in pain intensity, pain self-efficacy, anxiety, happiness and mobility after the motivational interviewing and physical exercise programme (all p < 0.05) for experimental group, while no significant improvement in control group except on the happiness scale. Regarding group differences in the outcome measures, the change scores on pain intensity, state anxiety and depression were significantly better in the experimental group. Motivational interviewing and physical exercise programme is effective in improving pain, physical mobility, psychological well-being and self-efficacy for community-dwelling older persons with chronic pain. Motivational interviewing is a feasible counselling technique whose content can be modified based on target group to change maladaptive behaviours, elicit ambivalences and enhance self-efficacy for making changes. Thus, promoting motivational interviewing and physical exercise programme to older persons with pain is effective and important.

Bee venom acupuncture for chronic low back pain: A randomised, sham-controlled, triple-blind clinical trial

AimThe aim of this trial was to determine whether bee venom acupuncture (BVA) is more effective than a sham control in reducing pain and disability in subjects suffering from chronic low back pain. Participants and methodsThe trial design was a randomised, sham-controlled, triple-blind, two-group parallel clinical trial. After screening, 60 participants were randomly divided into the BVA group or sham control group (normal saline injection: NSI). Both groups were treated twice a week for 4 weeks; 6 acupoints (BL23, BL24 and BL25 on bilateral sides) were injected with 0.1ml BVA or normal saline, respectively. The primary outcome measurement was the change in pain intensity (as measured with the visual analogue scale: VAS), and the secondary outcomes were assessed using the Oswestry Disability Questionnaire (ODQ) for disability and the SF-36 questionnaire for quality of life. ResultsBoth groups had significant improvements in pain intensity, ODQ, and SF-36 from baseline levels. Measurements of pain intensity showed a statistically significant difference in the VAS score in favour of BVA over control at the 8th treatment (p=0.0087). However, there was no significant difference between the two groups in either the ODQ and SF-36 measurements. All adverse reactions disappeared spontaneously without medical interventions. ConclusionsThese results suggest that BVA is effective for treating chronic low back pain and appears to be a safe therapy. Future trials need to consider more effective controls and blinding.

Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study

This open-label, phase 3b study (ClinicalTrials.gov Identifier: NCT00983073) evaluated the effectiveness, and tolerability of tapentadol for severe, chronic osteoarthritis knee pain that was inadequately managed with World Health Organization (WHO) Step I or II analgesics or co-analgesics, or that was not treated with regular analgesics. Prior to starting study treatment, patients discontinued any WHO Step II analgesics, while Step I analgesics and/or co-analgesics were continued at the same dose. Patients received tapentadol prolonged release (50–250 mg bid) during a 5-week titration period and a 7-week maintenance period. Doses of tapentadol immediate release 50 mg (≤twice/day; ≥4 hours apart) were permitted throughout the study (total daily dose of tapentadol prolonged and immediate release, ≤250 mg bid). The primary endpoint was the change in pain intensity on an 11-point numerical rating scale-3 (NRS-3; recalled average pain intensity [11-point NRS] during the last 3 days) from baseline to Week 6, using the last observation carried forward (LOCF) to impute missing pain intensity scores. The mean (standard deviation) change from baseline to Week 6 (LOCF) in pain intensity was −3.4 (2.10; P < 0.0001) for all patients evaluated for effectiveness (n = 195). Significant decreases in pain intensity were also observed at Weeks 6, 8, and 12 (all P < 0.0001) using observed-case analysis. Corresponding significant improvements from baseline to Weeks 6 and 12 were observed in the Western Ontario and McMaster Universities osteoarthritis index, the EuroQol-5 Dimension health status questionnaire, the Short Form-36 health survey, and the Hospital Anxiety and Depression Scale (all P ≤ 0.0103). Treatment-emergent adverse events were in line with those observed in previous studies of tapentadol prolonged release. Overall, the results of this study indicate that tapentadol treatment results in significant improvements in pain intensity, health-related quality of life, and function in patients with inadequately managed, severe, chronic osteoarthritis knee pain.

Efficacy of Duloxetine in Patients with Chronic Pain Conditions

The primary objective of this study is to review the efficacy of duloxetine in treating chronic pain using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations for clinical significance across chronic pain states. These include pain intensity, patient ratings of overall improvement, physical functioning, and mental functioning. This review comprised the side-by-side analyses of 12 double-blind, placebo-controlled trials of duloxetine in patients with chronic pain (diabetic peripheral neuropathic pain, fibromyalgia, chronic pain due to osteoarthritis, and chronic low back pain). Patients received duloxetine (60 to 120 mg/day) or placebo. Average pain reduction was assessed over 3 months as the primary efficacy outcome. Other measures used were physical function and Patient Global Impression of Improvement. In 10 of the 12 studies, statistically significant greater pain reduction was observed for duloxetine- compared with placebo-treated patients. The response rates based on average pain reduction, improvement of physical function, and global impression were comparable across all 4 chronic pain states. Compared with patients on placebo, significantly more patients treated with duloxetine reported a moderately important pain reduction (≥30% reduction) in 9 of the 12 studies, a minimally important improvement in physical function in 8 of the 12 studies, and a moderately important to substantial improvement in Patient Global Impression of Improvement rating in 11 of the 12 studies. The analyses reported here show that duloxetine is efficacious in treating chronic pain as demonstrated by significant improvement in pain intensity, physical functioning, and patient ratings of overall improvement.

Comparing the Effectiveness of Mindfulness-based Stress Reduction and Multidisciplinary Intervention Programs for Chronic Pain

Research suggests that an 8-week Mindfulness-Based Stress Reduction (MBSR) program (a structured form of meditation) might be effective in the treatment of various health problems including chronic pain. Our objective was to compare the clinical effectiveness of the MBSR program with a multidisciplinary pain intervention (MPI) program in terms of pain intensity, pain-related distress, quality of life, and mood in patients with chronic pain. A randomized, comparative clinical trial was conducted, including 6-month posttreatment follow-up. Ninety-nine participants, aged 24 to 64 years, with pain for a minimum of 3 months, were recruited from community-based clinics, hospitals, and community service centers. Participants were randomly allocated to either the MBSR program (51 participants) or a MPI program (48 participants). The study used validated Chinese versions of self-reported questionnaires measuring pain, mood symptoms, and health-related quality of life. Thirty-nine participants (77%) completed the MBSR program and 44 (90%) completed the MPI program. Patients in both the groups were comparable with regard to demographical characteristics, pain intensity, mood symptoms, and health-related quality-of-life measures before intervention. In both the groups, patients who completed the trial demonstrated statistically significant improvements in pain intensity and pain-related distress. However, no statistically significant differences were observed in overall results between the MBSR and MPI groups. This randomized, clinical trial showed that both MBSR and MPI programs reduced pain intensity and pain-related distress although no statistically significant differences were observed between the 2 groups and the improvements were small.

Outcomes Associated with a Cognitive-Behavioral Chronic Pain Management Program Implemented in Three Public HIV Primary Care Clinics

In patients with HIV/AIDS, chronic pain is common and analgesics pose serious risks. Cognitive-behavioral therapies (CBT) provide an alternative. This study evaluated feasibility and impact of a CBT-based pain management program in three public primary care clinics for HIV patients. The program included a workbook and 12-weeks of group CBT sessions. HIV-positive patients with chronic moderate to severe pain were invited to participate in the program and were assessed at enrollment, 6, 12, and 24weeks. Despite only moderate group attendance, program enrollment was associated with significant improvements in pain intensity, pain-related functioning, anxiety and acceptance, and mental health. At 24weeks, effect sizes for pain outcomes were -0.83 for pain intensity and -0.43 for functioning. The pattern of change in outcomes was consistent with predictions based on cognitive-behavioral theory. Effects were observed at all clinics. Adding CBT-based pain management into primary care may provide important benefits for patients with HIV/AIDS.

Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase

BackgroundChronic pain is a significant problem for many individuals following spinal cord injury (SCI). Unfortunately, SCI-related neuropathic pain has proven to be largely refractory to analgesic medications and other available treatments. Cranial electrotherapy stimulation (CES) has been effective in managing some types of pain. It involves the application of a small amount of current through the head via ear clip electrodes.ObjectiveExplore the effectiveness of CES for neuropathic pain in persons with SCI and chronic pain.Study designMulti-site, double-blind, sham-controlled study.ParticipantsAdults with SCI and chronic neuropathic pain at or below the level of injury were randomized to receive active or sham CES.InterventionApplication of active CES or sham CES 1 hour daily for 21 days. Six-month open-label phase to assess ‘as-needed’ CES use.Outcome measuresChange in pre- to post-session pain ratings as well as change in pain intensity, pain interference, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety pre- to post-treatment.ResultsThe active group reported a significantly greater average decrease in pain during daily treatments than the sham group (Kruskal–Wallis chi-square = 4.70, P < 0.05). During the 21-day trial, there was a significant group × time interaction for only one outcome variable; the active group showed larger pre- to post-treatment decreases in pain interference than the sham group did (F = 8.50, P < 0.01, d = 0.59).ConclusionsOn average, CES appears to have provided a small but statistically significant improvement in pain intensity and pain interference with few troublesome side effects. Individual results varied from no pain relief to a great deal of relief.

Specific exercises to treat pregnancy-related low back pain in a South African population

Objective To investigate the effect of an exercise program, including specific stabilizing exercises, on pain intensity and functional ability in women with pregnancy-related low back pain. Methods Fifty women between 16 and 24 weeks of pregnancy were recruited at Tygerberg and Paarl Hospitals, Western Cape, South Africa. Twenty-six women were randomized to a 10-week exercise program and 24 were randomized as controls. Results Overall, the most frequent type of back pain experienced was lumbar pain (36 [72.0%]). Pain intensity ( P = 0.76) and functional ability ( P = 0.29) were comparable between the groups on study entry. In the study group, there was a significant improvement in pain intensity ( P < 0.01) and an improvement in functional ability ( P = 0.06) at the end of the study. In the control group, there were no significant changes in pain intensity ( P = 0.89) or functional ability ( P = 0.70) at the end of the study. Conclusion A specific exercise program decreased back pain intensity and increased functional ability during pregnancy in South African women with lumbar and pelvic girdle pain.

Efficacy and Safety of Tapentadol Extended Release Compared with Oxycodone Controlled Release for the Management of Moderate to Severe Chronic Pain Related to Osteoarthritis of the Knee

Tapentadol is a novel, centrally acting analgesic with mu-opioid receptor agonist and norepinephrine reuptake inhibitor activity. to evaluate the efficacy and safety of Tapentadol extended release (ER) compared with oxycodone controlled release (CR) for management of moderate to severe chronic osteoarthritis-related knee pain. this was a randomized, double-blind, active- and placebo-controlled, parallel-arm, multicentre, phase III study during which patients received Tapentadol ER, oxycodone CR or placebo for a 3-week titration period followed by a 12-week maintenance period. The study was carried out at sites in Australia, Canada, New Zealand and the US. A total of 1030 patients with chronic osteoarthritis-related knee pain were randomized to receive Tapentadol ER 100-250 mg twice daily, oxycodone HCl CR 20-50 mg twice daily or placebo. Primary endpoints (as determined prior to initiation of the study) were the changes from baseline in average daily pain intensity (rated by patients on an 11-point numerical rating scale) over the last week of maintenance and over the entire 12-week maintenance period; last observation carried forward was used to impute missing values after early treatment discontinuation. efficacy and safety were evaluated for 1023 patients. Tapentadol ER significantly reduced average pain intensity from baseline to week 12 of the maintenance period versus placebo (least squares mean [LSM] difference [95% CI], -0.7 [-1.04, -0.33]), and throughout the maintenance period (-0.7 [-1.00, -0.33]). Oxycodone CR significantly reduced average pain intensity from baseline throughout the maintenance period versus placebo (LSM difference [95% CI], -0.3 [-0.67, -0.00]) but not at week 12 (-0.3 [-0.68, 0.02]). A significantly higher percentage of patients achieved > or =50% improvement in pain intensity in the Tapentadol ER group (32.0% [110/344]) compared with the placebo group (24.3% [82/337]; p = 0.027), indicating a clinically significant improvement in pain intensity, while a significantly lower percentage of patients achieved > or =50% improvement in pain intensity in the oxycodone CR group (17.3% [59/342]; p = 0.023 vs placebo). In the placebo, Tapentadol ER and oxycodone CR groups, respectively, 61.1% (206/337), 75.9% (261/344) and 87.4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26.1% (88/337), 43.0% (148/344) and 67.3% (230/342). treatment with Tapentadol ER 100-250 mg twice daily or oxycodone HCl CR 20-50 mg twice daily was effective for the management of moderate to severe chronic osteoarthritis-related knee pain, with substantially lower incidences of gastrointestinal-related TEAEs associated with treatment with Tapentadol ER than with oxycodone CR.

Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain

Background and objectives:Breakthrough cancer pain (BTcP) represents an important clinical challenge in the care of patients with cancer. This trial evaluated the efficacy and long-term tolerability of a sublingual formulation of the fast-acting opioid fentanyl, for the treatment of BTcP in opioid-tolerant patients with cancer.Research design and methods:This was a randomized, placebo-controlled, multi-center, phase III trial, conducted in opioid-tolerant male and female patients (aged ≥17 years) with BTcP. The study was conducted at 36 centers across the USA. The study comprised a 2-week open-label titration phase, followed by a double-blind efficacy phase, during which patients received sublingual fentanyl citrate orally disintegrating tablet (sublingual fentanyl ODT) or placebo, in a random order. The primary efficacy endpoint was the sum of pain intensity difference (SPID) over 30 min post-administration. Secondary efficacy endpoints included pain intensity difference (PID) and pain relief (PR) throughout the 60-min post-dose assessment period. Following efficacy evaluation, patients entered a long-term safety phase of up to 12 months. Adverse events were recorded throughout the study. [Clinical trial registration: NCT00262678]Results:A total of 131 patients entered the titration phase, of whom 61 were included in the primary efficacy analysis. Sublingual fentanyl ODT provided significant improvements in SPID relative to placebo at 30 min (49.5 vs. 36.6, p = 0.0004) and 60 min post-administration (143.0 vs. 104.5, p = 0.0002). Furthermore, sublingual fentanyl ODT provided significant improvements in PID and PR compared to placebo, from 10 min post-dose (p = 0.0055 and p = 0.049 for PID and PR, respectively). Patient recruitment was stopped early, due to positive interim analysis results (significant at prespecified level, p ≤ 0.0414). Overall, sublingual fentanyl ODT was well-tolerated both systemically and sublingually, with 41 patients experiencing ≥1 study drug-related adverse event (AE). The most common AEs included nausea (12.2%), vomiting (5.3%) and somnolence (4.6%). One serious AE (mild affect lability) was considered possibly related to study medication. The observed pattern of AEs was consistent with that previously observed with fentanyl.Conclusions:Sublingual fentanyl ODT was efficacious and well-tolerated for the treatment of BTcP in opioid-tolerant patients with cancer. Sublingual fentanyl ODT provided significant improvements in pain intensity compared to placebo, from 10 min post-administration and throughout the 60-min post-dose assessment period. Sublingual fentanyl ODT was well tolerated over 12 months of treatment.

SP154 – Dexamethasone effect on post-tonsillectomy recovery period

OBJECTIVES: To assess the effectiveness of dexamethasone at induction of anesthesia on post-tonsillectomy. METHODS: Study prospectively involved 379 adult and children tonsillectomy cases. Cases were randomized into two groups. First group received an intravenous single dose of dexamethasone at induction of anesthesia and second was a control group. The FLACC Pain Scale, episodes of vomiting, need for analgesia or antiemetics, and time and volume of oral intake were used to determine the early post-operative morbidity. Post-discharge, the Wong-Baker faces pain rating scale and patient care diary sheets were used to collect data for 10 days, mainly about post-operative nausea and vomiting. RESULTS: There were statistical significant improvement in PONV due to the use of dexamethasone in all ages (p 0.035 in adults and 0.025 in children), significant improvement in pain intensity only early post-operatively (p 0.02) and significant reduction in the use of pain medications early postoperatively (p 0.04). The time until first oral fluid and soft diet intake significantly shortened (p 0.04 and 0.01). The incidence of post-operative bleeding was higher in the dexamethasone group. CONCLUSIONS: A single dexamethasone dose at induction of anesthesia during both adults and children tonsillectomies significantly reduces the PONV and to some extent pain intensity and improves the post-operative oral intake. Although the study found this method for reducing post-tonsillectomy morbidity safe and inexpensive, the increased risk of postoperative bleeding needs further review.

Fentanyl buccal tablet: rapid relief from breakthrough pain

Breakthrough pain – a transient increase in pain occurring over a baseline of controlled persistent pain – represents an important clinical challenge in the management of cancer and other chronic pain conditions. The fentanyl buccal tablet is a new sugar-free, easily-administered formulation that uses an effervescent drug delivery system to enhance the rate and extent of fentanyl absorption across the buccal mucosa. Clinical trials indicate that the rapid systemic exposure provided by fentanyl buccal tablets translates into clinically significant improvements in pain intensity. Pain relief is observed within 10 – 15 min of administration. Fentanyl buccal tablets are generally well tolerated, with the most commonly observed adverse events being typical opioid side effects. Fentanyl buccal tablets represent a convenient and effective treatment for the control of breakthrough pain.

Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial

Objective To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee.Design Multicentre, randomised...

A randomized, double-blind, 8-week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain

Objective: The purpose of this study was to evaluate the efficacy of controlled-release (CR) tramadol and immediate-release (IR) tramadol in patients with moderate or greater intensity chronic noncancer pain. Methods: A total of 122 patients underwent washout from all opioids 2 to 7 days before randomization to 1 of 2 groups: active CR tramadol 200 mg every morning plus placebo IR tramadol 50 mg every 4 to 6 hours PRN rescue, or placebo CR tramadol 200 mg every morning plus active IR tramadol 50 mg every 4 to 6 hours PRN rescue. After 2 weeks, the doses were increased to CR tramadol 400 mg or placebo and IR tramadol 100 mg every 4 to 6 hours PRN or placebo, as rescue. After 4 weeks in the first phase, patients crossed over to the alternative treatment for another 4 weeks. Pain intensity (100-mm visual analog scale [VAS] and 5-point ordinal scales) was assessed twice daily in diaries. Pain intensity, Pain and Disability Index (PDI; 0–10 ordinal scale), Pain and Sleep Questionnaire (100-mm VAS), and analgesic effectiveness (7-point ordinal scale) were assessed at biweekly clinic visits. Results: Sixty-five patients (35 men, 30 women) completed the study. Mean (SD) age was 56.5 (12.7) years; mean (SD) weight was 82.0 (18.5) kg. Daily diary pain intensity (mean [SD]) was significantly lower in the CR tramadol group than in the IR tramadol group in the last 2 weeks of each phase (completers: VAS, 29.9 [20.5] vs 36.2 [20.4] mm, P < 0.001; ordinal scale, 1.41 [0.7] vs 1.64 [0.6], P < 0.001; intent-to-treat [ITT] population: VAS, 32.5 [22.9] vs 38.6 [21.2] mm, P < 0.003; ordinal scale, 1.50 [0.8] vs 1.72 [0.7], P < 0.002). The overall pain intensity scores from the daily diary were also significantly better with CR tramadol for both the completers and ITT. Similar results were obtained on the biweekly VAS pain intensity questionnaire. No differences were found between treatments in total PDI or overall Pain and Sleep scores in either population. For the completers, both patients and investigators rated effectiveness higher for CR tramadol than for IR tramadol ( P < 0.004 and P < 0.008 for patients and investigators, respectively). Conclusion: This study reports significant improvement in pain intensity with CR tramadol as compared with IR tramadol.

Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled Efficacy and Tolerability Study of Tramadol Extended Release for the Treatment of Osteoarthritis Pain in Geriatric Patients

Background: Once-daily tramadol extended release (ER) was evaluated for 12 weeks in a randomized, double-blind, placebo-controlled, parallel-group study in 1020 patients with osteoarthritis of the knee or hip. As previously reported, compared with placebo, the results of the study showed that patients treated with tramadol ER had significant improvement in the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and in pain-related sleep parameters. Objective: Because chronic/persistent arthritis pain is common in geriatric patients, this post hoc analysis evaluated the efficacy and tolerability of tramadol ER in geriatric patients 65 years or older (n = 317) from this study. Methods: In the original study, the co-primary efficacy variables to evaluate the efficacy and tolerability of 100-, 200-, 300-, and 400-mg doses of tramadol ER were the WOMAC Osteoarthritis Index subscale scores for pain (0-500) and physical function (0-1700), and patient global assessment of disease (0-100). Secondary efficacy variables included arthritis pain intensity, 36-Item Short-Form Health Survey, daily pain diaries, sleep parameters, and tolerability assessments. Patients rated their arthritis pain utilizing a 100-mm visual analog scale (VAS) (0 = no pain, 100 = extreme pain). Sleep parameters were evaluated based on a 100-mm VAS (0 = never, 100 = always). Results: A total of 317 patients 65 years or older were included in the analysis (186 women, 131 men). Compared with placebo, this analysis found a significant improvement from baseline to the final visit in the co-primary efficacy variables of pain (least-squares [LS] mean [SE], 108.7 [16.9]; P ≤ 0.05) and physical function (LS mean [SE], 366.4 [57.7]; P ≤ 0.05) subscale scores of the WOMAC Osteoarthritis Index; the patient global assessment of disease activity (LS mean [SE], 27.9 [3.9]; P ≤ 0.01) for the tramadol ER 300-mg group; and for the pain-related sleep effects for less awakenings by pain in the morning (100-, 200-, and 300-mg groups; P ≤ 0.05), less awakenings by pain during the night (200- and 300-mg groups; P ≤ 0.035), significantly better overall sleep quality (200-mg group only; P = 0.037), and less trouble falling asleep due to pain (200-mg group only; P = 0.025). Commonly reported adverse events in patients 65 years or older treated with tramadol ER included constipation (27.5%), nausea (23.4%), dizziness (22.7%), and headache (15.6%). Conclusions: This post hoc analysis suggests that the tramadol ER 300-mg dose was associated with statistically significant improvement in pain intensity and physical function, and for most of the pain-related sleep effects among these geriatric patients with moderate chronic/persistent pain.

Intramuscular and nerve root stimulation vs lidocaine injection to trigger points in myofascial pain syndrome

To compare the efficacies of an intramuscular stimulation technique and 0.5% lidocaine injection to trigger points in myofascial pain syndrome. Forty-three people with myofascial pain syndrome of the upper trapezius muscle. Twenty-two subjects were treated with intramuscular stimulation and another 21 with 0.5% lidocaine injection at all the trigger points on days 0, 7 and 14. Intramuscular stimulation resulted in a significant reduction in Wong-Baker FACES pain scale scores at all visits and was more effective than trigger point injection. Intramuscular stimulation also resulted in significant improvement on the Geriatric Depression Scale - Short Form. Local twitch responses occurred in 97.7% (42/43) of patients. All the passive cervical ranges of motion were significantly increased. Post-treatment soreness was noted in 54.6% of patients in the intramuscular stimulation group and 38.1% in the trigger point injection group, respectively, and gross subcutaneous haemorrhage (> 4 cm2) was seen in only one patient in the trigger point injection group. In managing myofascial pain syndrome, after one month intramuscular stimulation resulted in more significant improvements in pain intensity, cervical range of motion and depression scales than did 0.5% lidocaine injection of trigger points. Intramuscular stimulation is therefore recommended for myofascial pain syndrome.

The natural history of chronic painful peripheral neuropathy in a community diabetes population

To examine the natural history of chronic painful diabetic neuropathy (CPDN). A cross-sectional study of 350 people with diabetes was performed during 1998-1999 to assess the prevalence of CPDN in the community. Fifty-six patients with CPDN were identified and were followed up an average of 5 years later. From the original cohort, 12 patients had died and 14 had moved away or were unable to participate in the follow-up study. Thus 30 patients with CPDN [21 male, mean (SD) age 68.6 years (9.4), mean (SD) duration of diabetes 15.4 years (8.7)] were re-assessed. Seven (23%) had been pain free for at least 12 months and 23 continued to report neuropathic pain of similar quality and severity [total McGill Pain Questionnaire Score median (interquartile range) at follow-up 22 (16-39) vs. 20 (16-33) at baseline, P = 0.3; mean (SD) visual analogue scale (VAS) score for pain over the preceding 24 h 5.3 cm (2.9) vs. 4.6 cm (2.5) at baseline, P = 0.1]. Only 65% had ever received treatment for CPDN despite 96% (22/23) reporting pain to their physician; 43.5% had received antidepressants, 17.4% anticonvulsants, 39% opiates and 30% had tried complementary therapies. The neuropathic pain of CPDN can resolve completely over time in a minority (23%). In those in whom painful neuropathic symptoms had persisted over 5 years, no significant improvement in pain intensity was observed. Despite the improvement in treatment modalities for chronic pain in recent years, patients with CPDN continue to be inadequately treated.