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The relationship between pain catastrophizing, coping efficacy and objectively measured physical activity in adolescents with Juvenile Primary Fibromyalgia Syndrome
S16
B07 Joint and Muscle Pain (160) Evaluation of dexamethasone versus clonidine as adjuvants to 1.5% lignocaine with adrenaline in infraclavicular brachial plexus block for upper limb surgeries M Arora and D Shah; All India Institute of Medical Sciences, New Delhi, Delhi, India We conducted a prospective, randomized, placebo controlled study to evaluate the efficacy of clonidine and dexamethasone added as adjuvant to 1.5% lignocaine with 1:200,000 adrenaline in infraclavicular brachial plexus block in patients undergoing upper limb surgery. 53 ASA-I and II patients of 18 to 60 years of age, posted for upper limb surgery, were included in the study. All patients received freshly prepared 1.5% lignocaine with 1:200,000 adrenaline and the adjuvant was added to this solution. Patients were divided in three groups, group L, group D and group C. Group L received normal saline as placebo, group D received dexamethasone and group C received clonidine. The block was assessed for its effectiveness (complete, partial or failed block) until 30 min after giving the ICBPB. The total duration of surgery, use of tourniquet, and tourniquet pain was recorded. The intra-operative and post-operative hemodynamic and respiratory events and post-operative pain score were recorded. Postoperative patients were monitored for 24 hours. For postoperative analgesia, they received intravenous morphine with patient controlled analgesia pump. Total duration of sensory and motor blockade, time to first analgesia, total morphine consumption in 24 hours and numeric rating score at predetermined intervals was noted. Patients were monitored for any complication and treated for the same. Clonidine group had maximum successful blocks and dexamethasone had the least success rate. There was no difference in 24 hours morphine requirement, post operative NRS scores, and time to first analgesia, satisfaction scores between the 3 groups. Group C recorded hypotension postoperatively which was clinically insignificant. We concluded that Clonidine when added as adjuvant results in higher success rate as compared with Dexamethasone. Addition of Dexamethasone did not offer any advantage over Clonidine in terms of increasing the success rate, block characteristics and post operative analgesia requirement.
Abstracts (162) Neurological symptoms in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of phase 3 clinical trials D Petersel and P Bhadra; Pfizer, New York, NY There are an increasing number of reports suggesting the presence of neurological symptoms in patients with fibromyalgia (FM). The current study analyzed the prevalence of these symptoms and their relationship to pregabalin efficacy in FM patients pooled from 4 Phase 3 clinical trials. Patients diagnosed with FM according to ACR criteria, randomized to placebo (n=687) or 300 mg/ day (n=684), 450 mg/day (n=681) or 600 mg/day (n=563) pregabalin and with $1 post-baseline pain score were included in this analysis. Prior to randomization, patient-reported, voluntary medical histories were analyzed for past and present neurological symptoms. The following medical conditions were classified as indicators of neurological symptoms using ICD9 coding (patients could have $1): carpal tunnel syndrome (4.9%), dizziness (3.9%), headache (18.6%), migraine (20%), muscle spasms (4%), paraesthesia (2.6%), restless legs syndrome (2.5%), tension headache (4.4%), tinnitus (2.7%) and vertigo (2.5%). Two efficacy variables were examined: endpoint changes from baseline in weekly mean pain diary scores and Patient Global Impression of Change (PGIC). A large proportion of FM patients exhibited neurological disorders or symptoms, ranging from migraine and restless legs syndrome to dizziness, vertigo, paraethesia and tinnitus as 1163 out of 2615 (44.5%) had $1 of these conditions prior to or at the start of the studies. The efficacy analysis performed only on pregabalin treatment groups showed consistent pain reductions across groups with and without these symptoms (LSMEANS for neurological symptoms: present = -1.71, absent = -1.78 on an 11-point numerical rating scale). There were no statistically significant interactions between treatment groups and neurological symptoms for both pain diary scores and PGIC. This analysis suggests that neurological symptoms are common among FM patients, and that their presence is not associated with diminished pregabalin efficacy. (Funded by Pfizer Inc.)
B09 Myofascial Pain and Fibromyalgia
(163) Improvements in pain associated with fibromyalgia: results from 3 clinical trials of milnacipran
(161) The relationship between pain catastrophizing, coping efficacy and objectively measured physical activity in adolescents with Juvenile Primary Fibromyalgia Syndrome
M Geisser, R Palmer, Y Wang, W Chen, and R Gendreau; Forest Research Institute and Cypress Bioscience, Inc., Jersey City and San Diego, NJ and CA
S Flowers, S Kashikar-Zuck, E Verkamp, A Lynch-Jordan, D Strotman, T Ting, K Schikler, S Spalding, P Hashkes, M Richards, G Banez, L Arnold, S Powers, and D Lovell; Cincinnati Children’s Hospital, Cincinnati, OH Juvenile primary fibromyalgia syndrome (JPFS) is a chronic pain condition diagnosed in children and adolescents and characterized by widespread musculoskeletal pain, sleep difficulties, and fatigue. JPFS is associated with significant impairment in physical functioning. To date, little is known about how pain coping is associated with objectively measured physical activity levels in adolescents with JPFS. The aim of this study was to explore whether pain catastrophizing and coping efficacy were significantly associated with objective and subjective indicators of physical functioning in clinically-referred JPFS patients. Participants were 104 adolescents (ages 11-18; 89% female) recruited from three tertiary care pediatric rheumatology clinics. Physical functioning was assessed by 1) adolescent self-report on the Functional Disability Inventory and 2) activity monitoring for one week using a hip mounted actigraph (Acticalª). Participants also completed a daily pain diary for one week and completed the Pain Coping Questionnaire (PCQ). Two regression analyses were computed to examine whether pain catastrophizing and pain coping efficacy (as measured by the PCQ) significantly predicted functional disability and average daytime activity levels respectively. In each analysis, average pain intensity was controlled prior to entering the coping variables. Results indicated that pain intensity was the only variable significantly associated with self-reported disability, whereas none of the pain or coping variables were associated with activity levels measured by actigraphy. Correlational data showed that higher levels of catastrophizing were significantly related to self-reported physical functioning (r = .23; p < .05) but not actigraphy. These findings indicate that objective activity monitoring is not clearly related to adolescents self-report of physical functioning or subjective sense of coping. Potential sources of bias in adolescents’ self-report are discussed as well as recommendations for future studies in activity monitoring in adolescents with JPFS.
Chronic widespread musculoskeletal pain is the hallmark symptom of fibromyalgia (FM) and can contribute to significant impairment in multidimensional function and quality of life. Milnacipran, a dual serotonin-norepinephrine reuptake inhibitor, is approved for the management of FM. In FM clinical trials, milnacipran treatment was effective in improving pain and multiple symptoms (fatigue, global status, and physical functioning). In order to further characterize the effect of milnacipran on pain, 3-month data were analyzed from 3 FM trials (Study 1, N=888; Study 2, N=1196; Study 3, N=1025). In these studies, patients were randomized to placebo, milnacipran 100 mg/day, or milnacipran 200 mg/day (Studies 1 and 2 only). Pain data included 5 VAS measures collected at various recall intervals via an electronic diary (daily, weekly, or real-time) or by paper or wireless methods at study visits (daily and weekly recall). Brief Pain Inventory (BPI, Study 3 only) was administered at study visits. In OC analyses, milnacipran resulted in improvements in all 5 VAS pain measures with both doses in all studies. The changes were all significant (P<.05) except for the 100 mg/day arm in Study 1, in which the effect size was similar but the treatment arm was underpowered. Significant improvements in BPI pain interference and average pain severity scores were observed with milnacipran 100 mg/day compared with placebo (Study 3; P<.001). A significant reduction in pain scores in the milnacipran groups was observed during the second week of double-blind treatment, which was sustained through the 3-month endpoint. Additionally, a higher percentage of milnacipran-treated patients compared with placebo reported $30% reduction from baseline in pain scores in all 3 studies (P<.01). In 3 FM studies, treatment with milnacipran consistently resulted in significant pain improvements over placebo across a variety of pain measures. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)
B07 Joint and Muscle Pain (160) Evaluation of dexamethasone versus clonidine as adjuvants to 1.5% lignocaine with adrenaline in infraclavicular brachial plexus block for upper limb surgeries M Arora and D Shah; All India Institute of Medical Sciences, New Delhi, Delhi, India We conducted a prospective, randomized, placebo controlled study to evaluate the efficacy of clonidine and dexamethasone added as adjuvant to 1.5% lignocaine with 1:200,000 adrenaline in infraclavicular brachial plexus block in patients undergoing upper limb surgery. 53 ASA-I and II patients of 18 to 60 years of age, posted for upper limb surgery, were included in the study. All patients received freshly prepared 1.5% lignocaine with 1:200,000 adrenaline and the adjuvant was added to this solution. Patients were divided in three groups, group L, group D and group C. Group L received normal saline as placebo, group D received dexamethasone and group C received clonidine. The block was assessed for its effectiveness (complete, partial or failed block) until 30 min after giving the ICBPB. The total duration of surgery, use of tourniquet, and tourniquet pain was recorded. The intra-operative and post-operative hemodynamic and respiratory events and post-operative pain score were recorded. Postoperative patients were monitored for 24 hours. For postoperative analgesia, they received intravenous morphine with patient controlled analgesia pump. Total duration of sensory and motor blockade, time to first analgesia, total morphine consumption in 24 hours and numeric rating score at predetermined intervals was noted. Patients were monitored for any complication and treated for the same. Clonidine group had maximum successful blocks and dexamethasone had the least success rate. There was no difference in 24 hours morphine requirement, post operative NRS scores, and time to first analgesia, satisfaction scores between the 3 groups. Group C recorded hypotension postoperatively which was clinically insignificant. We concluded that Clonidine when added as adjuvant results in higher success rate as compared with Dexamethasone. Addition of Dexamethasone did not offer any advantage over Clonidine in terms of increasing the success rate, block characteristics and post operative analgesia requirement.
Abstracts (162) Neurological symptoms in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of phase 3 clinical trials D Petersel and P Bhadra; Pfizer, New York, NY There are an increasing number of reports suggesting the presence of neurological symptoms in patients with fibromyalgia (FM). The current study analyzed the prevalence of these symptoms and their relationship to pregabalin efficacy in FM patients pooled from 4 Phase 3 clinical trials. Patients diagnosed with FM according to ACR criteria, randomized to placebo (n=687) or 300 mg/ day (n=684), 450 mg/day (n=681) or 600 mg/day (n=563) pregabalin and with $1 post-baseline pain score were included in this analysis. Prior to randomization, patient-reported, voluntary medical histories were analyzed for past and present neurological symptoms. The following medical conditions were classified as indicators of neurological symptoms using ICD9 coding (patients could have $1): carpal tunnel syndrome (4.9%), dizziness (3.9%), headache (18.6%), migraine (20%), muscle spasms (4%), paraesthesia (2.6%), restless legs syndrome (2.5%), tension headache (4.4%), tinnitus (2.7%) and vertigo (2.5%). Two efficacy variables were examined: endpoint changes from baseline in weekly mean pain diary scores and Patient Global Impression of Change (PGIC). A large proportion of FM patients exhibited neurological disorders or symptoms, ranging from migraine and restless legs syndrome to dizziness, vertigo, paraethesia and tinnitus as 1163 out of 2615 (44.5%) had $1 of these conditions prior to or at the start of the studies. The efficacy analysis performed only on pregabalin treatment groups showed consistent pain reductions across groups with and without these symptoms (LSMEANS for neurological symptoms: present = -1.71, absent = -1.78 on an 11-point numerical rating scale). There were no statistically significant interactions between treatment groups and neurological symptoms for both pain diary scores and PGIC. This analysis suggests that neurological symptoms are common among FM patients, and that their presence is not associated with diminished pregabalin efficacy. (Funded by Pfizer Inc.)
B09 Myofascial Pain and Fibromyalgia
(163) Improvements in pain associated with fibromyalgia: results from 3 clinical trials of milnacipran
(161) The relationship between pain catastrophizing, coping efficacy and objectively measured physical activity in adolescents with Juvenile Primary Fibromyalgia Syndrome
M Geisser, R Palmer, Y Wang, W Chen, and R Gendreau; Forest Research Institute and Cypress Bioscience, Inc., Jersey City and San Diego, NJ and CA
S Flowers, S Kashikar-Zuck, E Verkamp, A Lynch-Jordan, D Strotman, T Ting, K Schikler, S Spalding, P Hashkes, M Richards, G Banez, L Arnold, S Powers, and D Lovell; Cincinnati Children’s Hospital, Cincinnati, OH Juvenile primary fibromyalgia syndrome (JPFS) is a chronic pain condition diagnosed in children and adolescents and characterized by widespread musculoskeletal pain, sleep difficulties, and fatigue. JPFS is associated with significant impairment in physical functioning. To date, little is known about how pain coping is associated with objectively measured physical activity levels in adolescents with JPFS. The aim of this study was to explore whether pain catastrophizing and coping efficacy were significantly associated with objective and subjective indicators of physical functioning in clinically-referred JPFS patients. Participants were 104 adolescents (ages 11-18; 89% female) recruited from three tertiary care pediatric rheumatology clinics. Physical functioning was assessed by 1) adolescent self-report on the Functional Disability Inventory and 2) activity monitoring for one week using a hip mounted actigraph (Acticalª). Participants also completed a daily pain diary for one week and completed the Pain Coping Questionnaire (PCQ). Two regression analyses were computed to examine whether pain catastrophizing and pain coping efficacy (as measured by the PCQ) significantly predicted functional disability and average daytime activity levels respectively. In each analysis, average pain intensity was controlled prior to entering the coping variables. Results indicated that pain intensity was the only variable significantly associated with self-reported disability, whereas none of the pain or coping variables were associated with activity levels measured by actigraphy. Correlational data showed that higher levels of catastrophizing were significantly related to self-reported physical functioning (r = .23; p < .05) but not actigraphy. These findings indicate that objective activity monitoring is not clearly related to adolescents self-report of physical functioning or subjective sense of coping. Potential sources of bias in adolescents’ self-report are discussed as well as recommendations for future studies in activity monitoring in adolescents with JPFS.
Chronic widespread musculoskeletal pain is the hallmark symptom of fibromyalgia (FM) and can contribute to significant impairment in multidimensional function and quality of life. Milnacipran, a dual serotonin-norepinephrine reuptake inhibitor, is approved for the management of FM. In FM clinical trials, milnacipran treatment was effective in improving pain and multiple symptoms (fatigue, global status, and physical functioning). In order to further characterize the effect of milnacipran on pain, 3-month data were analyzed from 3 FM trials (Study 1, N=888; Study 2, N=1196; Study 3, N=1025). In these studies, patients were randomized to placebo, milnacipran 100 mg/day, or milnacipran 200 mg/day (Studies 1 and 2 only). Pain data included 5 VAS measures collected at various recall intervals via an electronic diary (daily, weekly, or real-time) or by paper or wireless methods at study visits (daily and weekly recall). Brief Pain Inventory (BPI, Study 3 only) was administered at study visits. In OC analyses, milnacipran resulted in improvements in all 5 VAS pain measures with both doses in all studies. The changes were all significant (P<.05) except for the 100 mg/day arm in Study 1, in which the effect size was similar but the treatment arm was underpowered. Significant improvements in BPI pain interference and average pain severity scores were observed with milnacipran 100 mg/day compared with placebo (Study 3; P<.001). A significant reduction in pain scores in the milnacipran groups was observed during the second week of double-blind treatment, which was sustained through the 3-month endpoint. Additionally, a higher percentage of milnacipran-treated patients compared with placebo reported $30% reduction from baseline in pain scores in all 3 studies (P<.01). In 3 FM studies, treatment with milnacipran consistently resulted in significant pain improvements over placebo across a variety of pain measures. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)