The journal of pain : official journal of the American Pain Society
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Randomized Controlled Trial Multicenter Study
Early improvement in pain predicts pain response at endpoint in patients with fibromyalgia.
An unanswered, but clinically important question is whether there are early indicators that a patient might respond to duloxetine treatment for fibromyalgia pain. To address this question, pooled data from 4 double-blind, placebo-controlled trials in duloxetine-treated patients (N = 797) with primary fibromyalgia as defined by the American College for Rheumatology were analyzed. Classification and Regression Tree (CART) analysis was used to determine what level of early pain improvement as measured by the 24-hour average pain severity question on the Brief Pain Inventory (BPI) best predicted later response. The predictor variables tested were 10, 15, 20, 25, and 30% decrease in BPI 24-hour average pain from baseline to Week 1 and Week 2. The results of the CART analysis showed that for patients with ≥15% improvement in pain at Week 1 and ≥30% improvement at Week 2, the probability of response at 3 months was 75%. For patients with <15% improvement at both Week 1 and Week 2, the probability of not responding at 3 months was 86%. Quantifiable early improvement in pain during the first 2 weeks of treatment with duloxetine was highly predictive of response or nonresponse after 3 months of treatment. ⋯ This article presents early indicators that can highly predict later pain response or nonresponse in fibromyalgia patients treated with duloxetine. The results may aid clinicians to predict the likelihood of response at 3 months within the first 2 weeks of treatment.
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Adults who suffer from chronic pain are at increased risk for suicide ideation and attempts, but it is not clear whether adolescents with chronic pain are similarly at elevated risk. This study investigates whether chronic pain is associated with an increase in suicidal ideation/attempts independent of depression in a population sample of adolescents. We analyzed data from the National Longitudinal Study of Adolescent Health, a longitudinal study of a nationally representative sample of adolescents in the United States (N = 9,970). Most chronic pain was related to suicide ideation/attempt both in the last year (odds ratio [OR] 1.3-2.1) and during the subsequent year (OR 1.2-1.8). After controlling for depressive symptoms, headaches (OR = 1.3 last year, OR = 1.2 subsequent year) and muscle aches (OR = 1.3 last year) remained associated with suicide ideation but not suicide attempt. These findings show that chronic pain in adolescence is a risk factor for suicide ideation; this effect is partly but not fully explained by depression. Youth with comorbid depression and chronic pain are at increased risk of thinking about and attempting suicide. Clinicians should be alert to suicide ideation/attempt and comorbid depression in this at-risk population. ⋯ Adolescents who suffer from chronic pain are at increased risk for suicide ideation and attempt. Depressive symptoms account for the link between chronic pain and suicide attempt, but do not completely explain why adolescents with chronic pain show suicide ideation.
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Randomized Controlled Trial Multicenter Study Comparative Study
Reciprocal relationship between pain and depression: a 12-month longitudinal analysis in primary care.
Pain and depression are the most prevalent physical and psychological symptom-based disorders, respectively, and co-occur 30 to 50% of the time. However, their reciprocal relationship and potentially causative effects on one another have been inadequately studied. Longitudinal data analysis involving 500 primary care patients with persistent back, hip, or knee pain were enrolled in the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study. Half of the participants had comorbid depression and were randomized to a stepped care intervention (n = 123) or treatment as usual (n = 127). Another 250 nondepressed patients with similar pain were followed in a parallel cohort. Outcomes were assessed at baseline, 3, 6, and 12 months. Mixed effects model repeated measures (MMRM) multivariable analyses were conducted to determine if change in pain severity predicted subsequent depression severity, and vice versa. Change in pain was a strong predictor of subsequent depression severity (t-value = 6.63, P < .0001). Likewise, change in depression severity was an equally strong predictor of subsequent pain severity (t-value = 7.28, P < .0001). Results from the full cohort were similar in the clinical trial subgroup. In summary, pain and depression have strong and similar effects on one another when assessed longitudinally over 12 months. ⋯ This study strengthens the evidence for a bidirectional and potentially causative influence of pain and depression on one another. A change in severity of either symptom predicts subsequent severity of the other symptom. Thus, recognition and management of both conditions may be warranted, particularly when treatment focused on 1 condition is not leading to an optimal response.
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Randomized Controlled Trial Multicenter Study Comparative Study
A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education.
Cognitive behavioral therapy (CBT) is a widely accepted psychosocial treatment for chronic pain. However, the efficacy of CBT has not been investigated within a rural setting. Furthermore, few studies have utilized first-person accounts to qualitatively investigate the key treatment elements and processes of change underlying the well-documented quantitative improvements associated with CBT. To address these gaps, we conducted a randomized controlled trial (RCT) investigating the efficacy of group CBT compared to an active education condition (EDU) within a rural, low-literacy population. Posttreatment semistructured interviews of 28 CBT and 24 EDU treatment completers were qualitatively analyzed. Emerging themes were collated to depict a set of finalized thematic maps to visually represent the patterns inherent in the data. Patterns were separated into procedural elements and presumed change processes of treatment. Key themes, subthemes, and example extracts for CBT and EDU are presented; unique and shared aspects pertaining to the thematic maps are discussed. Results indicate that while both groups benefited from the program, the CBT group described more breadth and depth of change as compared to the EDU group. Importantly, this study identified key treatment elements and explored possible processes of change from the patients' perspective. ⋯ This qualitative article describes patient-identified key procedural elements and change process factors associated with psychosocial approaches for chronic pain management. Results may guide further adaptations to existing treatment protocols for use within unique, underserved chronic pain populations. Continued development of patient-centered approaches may help reduce health, treatment, and ethnicity disparities.
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Randomized Controlled Trial Multicenter Study
Subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with chronic, nonmalignant pain: a randomized controlled study.
Methylnaltrexone is effective for opioid-induced constipation (OIC) in advanced illness patients. This 4-week, double-blind, randomized, placebo-controlled study investigated the effect of subcutaneous methylnaltrexone on OIC in patients receiving opioids for chronic, nonmalignant pain. Patients (N = 460) received subcutaneous methylnaltrexone 12 mg once daily (QD) or every other day (alternating with placebo) compared with placebo. Assessments included bowel movement count, time of bowel movement, straining, sense of complete evacuation, Bristol Stool Form Scales, and quality of life. Within 4 hours of first dose, 34.2% of patients in both methylnaltrexone groups had rescue-free bowel movements (RFBMs) versus 9.9% on placebo (P < .001). The estimated number needed to treat was about 4. On average, 28.9% of methylnaltrexone QD and 30.2% of methylnaltrexone alternate-day dosing resulted in RFBMs within 4 hours versus 9.4% QD and 9.3% alternate-day placebo injections (both P < .001). Both methylnaltrexone groups had significantly shorter time to first RFBM (P < .001) and greater increase in number of weekly RFBMs (P < .05) versus placebo. Adverse events included abdominal pain, diarrhea, nausea, and hyperhidrosis. Bristol Stool Form Scale scores (P = .002) and sensation of complete evacuation (P < .04) were significantly superior with methylnaltrexone QD; both methylnaltrexone groups reported no or mild straining during RFBMs in the first 2 weeks (P < .02). At 4 weeks, a significantly greater improvement in patient-reported, constipation-specific quality of life was seen in the alternate-day dosing (P < .05) and QD (P < .001) groups. ⋯ We present data demonstrating that subcutaneous methylnaltrexone 12 mg given once daily (QD) or every other day provides significant relief of OIC and was generally well tolerated in patients with chronic, nonmalignant pain. These results expand on prior effectiveness observed for the treatment of OIC in advanced illness patients to a broader population.