Dennis C. Ang

Objectives: To evaluate the feasibility of a randomized-controlled trial and to obtain estimates of the effects of combined cognitive-behavioral therapy (CBT) and milnacipran for the treatment of fibromyalgia. Methods: Fifty-eight patients with fibromyalgia were randomized to 1 of the 3 treatment arms: (1) combination therapy (n=20); (2) milnacipran+education (n=19); and (3) placebo+CBT (n=19). Patients received either milnacipran (100 mg/d) or placebo. Patients also received 8 sessions of phone-delivered CBT or educational instructions, but only from baseline to week 9. Assessments were conducted at baseline, week 9, and 21. The primary endpoints were baseline to week 21 changes in weekly average pain intensity and physical function (SF-36 physical function scale). Results: Compared with milnacipran, combination therapy demonstrated a moderate effect on improving SF-36 physical function (SE=9.42 [5.48], P=0.09, effect size=0.60) and in reducing weekly average pain intensity (mean difference [SE]=−1.18 [0.62], P=0.07, effect size=0.67). Compared with milnacipran, CBT had a moderate to large effect in improving SF-36 physical function (mean difference [SE]=11.0 [5.66], P=0.06, effect size=0.70). Despite the presence of concomitant centrally acting therapies, dropout rate was lower than anticipated (15% at week 21). Importantly, at least 6 out of the 8 phone-based therapy sessions were successfully completed by 89% of the patients; and adherence to the treatment protocols was >95%. Conclusions: In this pilot study, a therapeutic approach that combines phone-based CBT and milnacipran was feasible and acceptable. Moreover, the preliminary data supports conducting a fully powered randomized-controlled trial. Clinical Trial Registration: NCT01038323.

Objectives: Regular exercise is associated with important benefits in patients with fibromyalgia (FM). Unfortunately, long-term maintenance of exercise after a structured program is rare. The present study tested the efficacy of Motivational Interviewing (MI) to promote exercise and improve symptoms in patients with FM. Methods: A total of 216 patients with FM were randomized to 6 MI sessions (n=107) or an equal number of FM self-management lessons (education control/EC, n=109). Co-primary endpoints were an increase of 30 minutes in moderate-vigorous physical activity and improvement in the Fibromyalgia Impact Questionnaire (FIQ)-Physical Impairment score, assessed at pretreatment, posttreatment, and 3-month and 6-month follow-up. Secondary outcomes included clinically meaningful improvements in FIQ score, pain severity ratings, and a 6-minute walk test. Results: There were no significant treatment group differences in either co-primary endpoint at 6-month follow-up. However, more MI participants than controls exhibited meaningful improvements in FIQ score at 6-month follow-up (62.9% vs. 49.5%, P=0.06). Compared with EC participants, MI participants also displayed a larger increment in their 6-minute walk test (43.9 vs. 24.8 m, P=0.03). In addition, MI was superior to EC in increasing the number of hours of physical activity immediately postintervention and in reducing pain severity both immediately after the intervention and at 3-month follow-up. Conclusions: Despite a lack of benefits on long-term outcome, MI seems to have short-term benefits with respect to self-report physical activity and clinical outcomes. This is the first study in FM that explicitly addresses exercise maintenance as a primary aim. Clinical Trial Registration: NCT00573612.

Approximately 20% of patients report persistent and disabling pain following total knee arthroplasty (TKA) despite an apparently normally functioning prosthesis. One potential risk factor for unexplained persistent pain is high levels of pain catastrophizing. We designed a three-arm trial to determine if a pain coping skills training program, delivered prior to TKA, effectively reduces function-limiting pain following the procedure in patients with high levels of pain catastrophizing. The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. NCT01620983

Objective. Although fibromyalgia (FM) is traditionally a non-inflammatory condition, emerging data also suggest that FM has an immunologic component.

Objective: To explore the possibility that cognitive–behavioral therapy (CBT) influences fibromyalgia symptoms via descending inhibition of nociception, we evaluated the effects of CBT on the nociceptive flexion reflex (NFR) threshold, an objective measure of spinal nociceptive transmission.Methods: Female fibromyalgia patients (n = 32) were randomized to 6 weekly sessions of telephone‐delivered CBT or usual care (UC). Assessments of the NFR threshold and clinical outcomes were conducted at baseline, week 6 (post‐CBT), and week 12.Results: From baseline to week 6, the NFR threshold increased in the CBT group and decreased in the UC group (mean ± SD 4.4 ± 13.7 mA versus −10.2 ± 9.9 mA; P = 0.005). This difference was also apparent at week 12 (mean ± SD 7.3 ± 9.2 mA for CBT versus −5.4 ± 13.5 mA for UC; P = 0.01). The groups reported similar reductions in NFR pain ratings at week 6 (mean ± SD −20.2 ± 23.9 for CBT versus −14.9 ± 16.4 for UC; P = 0.8) and week 12 (mean ± SD −8.9 ± 25.3 for CBT versus −10.8 ± 24.1 for UC; P = 0.4).Conclusion: Compared with UC, CBT reduced nociceptive responding in fibromyalgia patients. Moreover, while the UC group exhibited longitudinal decreases in both the stimulation level and pain associated with the NFR threshold, those receiving CBT required more intense stimulation to elicit the NFR as well as rated that stimulation as less painful than at baseline. These data indicate the need for a larger study to confirm that changes in nociceptive responsivity may underlie the benefits of CBT in fibromyalgia patients.

Objective. The combination of chronic musculoskeletal pain and depression is associated with worse clinical outcomes than either condition alone. In

Objective: To understand the reasons behind racial disparities in the use of total joint arthroplasty (TJA), we sought to examine the predictors of time to referral to orthopedic surgery for consideration of joint replacement.Methods: In this prospective, longitudinal study of 676 primary care clinic patients with at least a moderately severe degree of hip or knee osteoarthritis (OA), we examined the effects of race, health beliefs (i.e., perceived benefits and risks) of TJA, and clinical appropriateness of TJA on referral to orthopedic surgery.Results: The sample included 255 African Americans (38%) and 421 whites (62%); 523 patients had knee OA (78%) and 153 had hip OA (22%). Subjects were 60% male, with a mean ± SD age of 64 ± 9 years, a mean ± SD body mass index of 33.6 ± 8 kg/m², and a mean ± SD summary Western Ontario and McMaster Universities Osteoarthritis Index score of 56 ± 14, suggesting moderately severe OA. At baseline, African Americans perceived fewer benefits and greater risk from TJA than whites. There were no significant racial group differences in the proportions of cases deemed clinically appropriate for TJA. After controlling for potential confounders, clinical appropriateness (hazard ratio [HR] 1.95, 95% confidence interval [95% CI] 1.15–3.32; P = 0.01) predicted referral to orthopedic surgery. Neither race (HR 1.30, 95% CI 0.94–2.05; P = 0.1) nor health beliefs (HR 1.0, P = 0.5) were associated with referral status.Conclusion: In this sample of primary care clinic patients, African Americans and whites were equally likely to be referred by their physicians to orthopedic surgery. Clinical appropriateness predicted future referral to orthopedic surgery, and not race or TJA‐specific health beliefs.

Objective.: Ethnic disparities in the use of total joint arthroplasty (TJA) may be attributed to differences in the clinical appropriateness to undergo TJA. We sought to determine if racial differences in clinical appropriateness for surgery existed among a sample of primary care clinic patients with moderately to severely symptomatic knee or hip osteoarthritis (OA).Methods.: We used the cross-sectional data of 684 patients who are potential candidates for TJA. Using a validated TJA appropriateness algorithm, an appropriateness factor was derived using the following variables: age (50–70 or > 70 yrs), Charlson comorbidity (≤ 1 or > 1), Western Ontario and McMaster Universities OA Index (WOMAC) pain and physical function, and adequacy of previous medical management. We used logistic regression to estimate the association of race with the dichotomous outcome of clinical appropriateness for TJA consideration.Results.: Sample consisted of 425 (62%) whites and 260 (38%) African Americans; 532 (78%) had knee OA and 153 (22%) had hip OA. The mean age was 64 ± 9 years and the mean body mass index was 33.6 ± 8 kg/m². The mean overall WOMAC score was 56 ± 14 (range 30–96), suggesting moderately severe OA. There were no significant racial group differences (p = 0.3) in the proportions of those deemed clinically appropriate for TJA. After controlling for potential confounders, race was not a predictor of clinical appropriateness for TJA (odds ratio 1.2, 95% confidence interval 0.8–1.8, p = 0.3).Conclusion.: African Americans and whites were equally appropriate to be considered for TJA.