Journal of pain and symptom management
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J Pain Symptom Manage · Jan 2005
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy, safety, and steady-state pharmacokinetics of once-a-day controlled-release morphine (MS Contin XL) in cancer pain.
The efficacy, safety, and pharmacokinetics of a novel once-daily morphine formulation (OAD morphine) and a 12-hourly formulation (twice-daily CR morphine) were compared in a double-blind, multi-centered crossover study. Chronic cancer pain patients (n=25) were randomized to OAD morphine (mean 238 +/- 319 mg q24h) or twice-daily CR morphine (mean 119 +/- 159 mg q12h) for one week. They then crossed over to the alternate drug, which also was taken for one week. ⋯ The AUC ratio was 100.3%, indicating equivalent absorption. Fluctuation indices were 93.5 +/- 28.8% and 179.3 +/- 41.3% (P=0.0001) for OAD morphine and twice-daily CR morphine, respectively. OAD morphine provides analgesia similar to twice-daily CR morphine with reduced fluctuation in plasma morphine concentration and more stable pain control.
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J Pain Symptom Manage · Oct 2004
Randomized Controlled Trial Comparative Study Clinical TrialPsychometric update of the Functional Interference Estimate: a brief measure of pain functional interference.
The Functional Interference Estimate (FIE) is a brief, 5-item self-report measure that assesses the degree to which pain interferes with daily functioning. While the FIE has demonstrated reliability and validity with a small normative sample, not much is known about its reliability and validity with a broad sample of individuals with pain. ⋯ The FIE has excellent internal consistency and appears to have strong convergent validity with other well-established measures of function (e.g., SF-36 and Dartmouth COOP Charts). Because of its brevity and flexibility, the FIE may be a useful self-report measure of pain functional interference in clinical research on pain.
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J Pain Symptom Manage · Sep 2004
Randomized Controlled Trial Clinical TrialElectronic pain diary: a randomized crossover study.
Electronic pain diaries and palm-top computers have become increasingly important in clinical research and practice. In a randomized crossover trial, 24 patients suffering from chronic cancer and non-cancer pain completed both the electronic and the paper version of a pain diary based on the Minimal Documentation System (MIDOS) for pain and symptom assessment. This includes daily assessment of pain on an 11-point numeric rating scale and weekly documentation of a short quality-of-life questionnaire. ⋯ The electronic diary was used more frequently and patients said its use supported a more regular pharmacotherapy. We conclude that the use of electronic pain diaries is a valid and feasible method for documenting patients' pain perception, though some patients may not be able to operate such a diary version. Electronic palm-top pain diaries provide a high degree of patient satisfaction and can ease data collection for clinical research and practice.
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J Pain Symptom Manage · Jul 2004
Randomized Controlled Trial Clinical TrialEfficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee.
The efficacy and safety of a once-daily extended-release formulation of tramadol hydrochloride (tramadol ER) was evaluated in patients with moderate to severe chronic pain of osteoarthritis (OA). This was a randomized, double-blind, placebo-controlled, parallel-group, 12-week study. Eligible patients with radiographically confirmed OA of the knee meeting the American College of Rheumatology diagnostic criteria, defined by knee pain and presence of osteophytes, plus at least age >50 years, morning stiffness <30 minutes in duration, and/or crepitus, entered a 2-7 day washout period during which all analgesics were discontinued. ⋯ Similarly, outcomes on the WOMAC Pain, Stiffness and Physical Function subscales, the WOMAC Composite Scale, dropouts due to insufficient therapeutic effect, Patient and Physician Global Assessment of Therapy, and Sleep were all significantly better with tramadol ER than placebo (P < 0.001 to < 0.05). Treatment with tramadol ER results in statistically significant and clinically important and sustained improvements in pain, stiffness, physical function, global status, and sleep in patients with chronic pain. A once-a-day formulation of tramadol has the potential to provide patients increased control over the management of their pain, fewer interruptions in sleep and improved compliance.
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J Pain Symptom Manage · Jun 2004
Randomized Controlled Trial Clinical TrialWhat works for therapists conducting family meetings: treatment integrity in family-focused grief therapy during palliative care and bereavement.
The purpose of this study was to evaluate the treatment integrity of Family-Focused Grief Therapy (FFGT), a preventive intervention designed for families at high risk of poor functioning during palliative care and bereavement. From the 81 families participating in a randomized controlled trial (53 assigned to therapy), 28 were randomly selected for this study of treatment fidelity using the FFGT integrity measure. A total of 109 family sessions were appraised. ⋯ Therapists averaged 10 grief-related questions per session, 7 on communication-related issues during assessment, 7 on conflict late in therapy, and 4 on cohesiveness across the course of therapy. Consistent application of FFGT, with attention to its four key themes of family communication, cohesiveness, conflict resolution, and shared grief has been demonstrated. The model is generalizable when applied by family therapists.