Fibromyalgia: characteristics, diagnosis, and management

Fibromyalgia

More than 50% of patients diagnosed with fibromyalgia (FM) suffer from major depression. In light of this significant statistic, this Evidence-based Practice (EBP) study explores the problem of depression in patients diagnosed with fibromyalgia, the clinical problem selected for this study.

In fibromyalgia, Antai-Otong (2005) stresses, pain management purports a pivotal treatment aspect for patients contending with the disease. To effectively treat FM, a holistic and interdisciplinary team approach focusing on pain management and mitigation of depression, along with other psychiatric symptoms proves pertinent. The most successful treatment strategies integrate: "pharmacotherapy, a graded exercise program, and cognitive behavioral therapy." (Hassett, Cone, Patella, & Sigal, 2000; Millea & Holloway, 2000; Thieme, Turk, & Flor, 2004; cited by Antai-Otong, 2005) Fibromyalgia, not deemed to be a distinct syndrome, reportedly affects approximately five million individuals, primarily women, in the U.S. (APA, 2000; Hudson, Arnold, Keck, Auchenbach, & Pope, 2004; cited by Antai-Otong, 2005) North American research indicates the prevalence estimate of FM to average 3.4% for women and 0.5% for men.

These percentages increase to 7.1 and 1.1%, respectively, for individuals in the 60-69-year age range. (Costal et al., 2005, p. 1422) as a chronic, recurrent, and potentially debilitating syndrome characterized by pain, fatigue and sleep problems, FM appears to constitute "part of an intricate spectrum of other medical conditions classified as somataform disorders," numerous clinicians frequently minimize or misdiagnose and/or under-treated patients. (Antai-Otong, 2005; "FDA Approves First Drug," 2007) in 2005, the FDA had not yet approved any drug for the treatment of FMS. (Antai-Otong, 2005) on June 21, 2007, however, the U.S. Food and Drug Administration approved the first drug to treat fibromyalgia - Lyrica (pregabalin), a disorder characterized by pain, fatigue and sleep problems. "Lyrica reduces pain and improves daily functions for some patients with fibromyalgia."("FDA Approves First Drug," 2007) Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, albeit, stresses that more progress needs to be made for treatment of FM, as a number of patients did not experience a pain relief with Lyrica in clinical trials. ("FDA Approves First Drug," 2007) for the diagnoses of fibromyalgia, which affects approximately three to six million to 6 million people (primarily women in early-to-middle adulthood) in the U.S., doctors conduct physical examinations, evaluate symptoms, and rule out other conditions. "Individuals with fibromyalgia have been shown to experience pain differently from other people." ("FDA Approves First Drug," 2007) Diagnostic criteria for FMS include:

Widespread pain for at least 3 months and not localized in one area -- involves both side of body, over and above the waist, and axial skeletal pain

Presence of 11 out of 18 tender points, including Designated occipital sites Lower cervical trapezius, gluteal area Greater trochanter and knees

Sleep disturbances during non-rapid eye movement (NREM) sleep, reduced delta sleep, and increased arousal, leading to sleep deprivation or unrestful sleep

Depression, emotional distress

Fatigue (American Psychiatric Association, 2000; cited by Antai-Otong, 2005)

The specific cause of FMS is not clearly confirmed, albeit, researchers currently suspect abnormalities in neuroendocrine systems such as hypothalamic-pituitary -- adrenal axis (HPA axis) as contributing causes. "Inquiries into FMS indicate the relationship between neurobiologic, psychosocial, and behavioral factors in pain syndromes." (Antai-Otong, 2005)

In addition, ongoing evidence reveals doctors routinely recommend antidepressants in the treatment of FMS. As FM is significantly associated with depression (or symptoms of depression), this researcher contends this consideration merits exploration and serves as significant rationale for further study. Increasing evidence suggests that an individual experiencing depression related to FM may also contend with increased pain, consequently adversely affecting his/her to cope with everyday activities. "Exercise training has been used successfully to address a number of conditions that are also commonly experienced by individuals with FMS. Aerobic and strength training have been shown to improve depression in individuals with clinical depression."(Brosse (2002, Dunn 2001; cited by Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 3) When individuals with sleep complaints exercise moderately, this practice can reportedly improve their sleep. (King 1997, Singh 1997; Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 3) Training-induced improvements in cardio-respiratory fitness appears to suggest fatigue may also be decreased with moderate exercise. As one's maximal aerobic capacity improves, a person will be able to perform activities of daily living at lower absolute percentages of maximal capacity. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 3)

Place for participants here ____ treats FM patients or where participants for this study are selected from. During the course of their treatments, nurses fulfill their responsibility to ____ for FM patients, while or something similar? simultaneously seeking to ease pain and decrease depression.

Utilizing the PICO form, this study proposes the relevant practice question: Does the implementation of group therapy sessions contribute to more effective pain management for individuals diagnosed with FM? In the quest to answer this pertinent clinical question, the population (P) is defined as FM patients requiring prescribed medications; the intervention (I) consists of weekly group therapy (support) sessions for 12 weeks; the comparison - constitutes current FM patients not attending weekly group therapy (support) sessions; the outcome (0) denotes decreased pain as a result of participation in the weekly group therapy (support) sessions

II. Methodology

Self-report can be erroneous if the participant wants to be viewed positively by others, or if there is recall bias." (Dobkin, et al., 2006)

To research literature utilized in this study, this researcher chose to utilize Ovid Medline, the Cumulative Index to Nursing and Allied Health and literature one (one CINAHL), and the Cochrane Collection. These databases contain credible, research studies, containing an excellent level of evidence, necessary mandated for evidence-based practice decisions in medicine, as well as in nursing. This researcher initially searched Ovid for information/data for this study. Key words and/or phrases for information/data included "fibromyalgia," "treatment of fibromyalgia," and "fibromyalgia and depression." These key search words and phrases were then connected in a variety of ways, consequently yielding ____ results.

English constituted the language for research studies. Studies completed within last 10 years were selected to review the most contemporary evidence. This researcher purposely focused on studies relating to pain associated with FM as a dearth of literature exists on group thereapy (support) for FM patients. Criteria for exclusion stipulated studies not matching that defined in the PICO question, as well as, studies ____ (need to add what other criteria used to exclude studies). From results retrieved through the literature search, this researcher defined the intervention as the implementation of group therapy (support) with participant journaling.

Ultimately, from retrieved researched results, this researcher identified four studies that met all the established inclusion and exclusion criteria previously identified. An identical search performed in the Cochrane database only yielded one result, which had had been obtained through prior research. This researcher conducted a more intensive search of the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials utilizing the following terms: "____,"

____," and "____," yet found no relevant results such as, meta-analyses, systematic reviews or randomized-controlled clinical trials.

III. Literature Review

Fibromyalgia (FMS) is a syndrome characterized by widespread musculoskeletal pain and multiple tender points (TP)."

Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994)

Study

The first study matching the criteria established for this study: "Exercise for treating fibromyalgia syndrome, an updated systematic review (initially published during 2002), proposes to assess effects evolving from exercise training "including cardio-respiratory (aerobic), muscle strengthening, and/or flexibility exercise on global well-being, selected signs and symptoms, and physical function in individuals with FMS." (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 1) the research design utilized for this study included the analysis of researched literature secured from "MEDLINE, EMBASE, CINAHL, SportDiscus, PubMed, PEDro, and the Cochrane Central Register for Controlled Trials (CENTRAL, Issue 3, 2005) up to and including July 2005." (Busch, Barber, Overend, Peloso, and Schachter, 2007) in addition, Busch, Barber, Overend, Peloso, and Schachter (2007, p. 1) reviewed

Reference List s, retrieved from reviews and meta-analyses of treatment studies.

The procedure for the study by Busch, Barber, Overend, Peloso, and Schachter (2007, p. 1) consisted of the authors selecting, collecting and analyzing randomized trials focusing on "cardio-respiratory endurance, muscle strength and/or flexibility as treatment for FMS.... Two of four reviewers independently extracted data for each study." The reviewers additionally rechecked any/all observed discrepancies noted in trials and subsequently achieved consensus via discussions. Busch, Barber, Overend, Peloso, and Schachter (2007, p. 1)) assessed the reviewed studies methodological quality utilizing two credible instruments: the Jadad, along with, the van Tulder methodological quality criteria. The authors utilized the American College of SportMedicine (ACSM) guidelines to evaluate whether interventions provided a training stimulus to effect changes in physical fitness. The significant clinical heterogeneity among the studies the authors examined contributed to the inclusion of meta-analyze six aerobic-only studies and two strength-only studies.

The initial 2276 total subjects across the 34 included studies were narrowed to 1264 subjects assigned to exercise interventions.

In this review, 47 interventions included exercise in 34 studies. Utilizing standardized mean differences (SMD), the authors then summarized effects of numerous dissimilar interventions on global well-being, selected signs and symptoms, and physical function in individuals with FMS. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 8)

Results from this study relate a moderate quality evidence that aerobic-only exercise training at recommended intensity levels produces positive effects "global well-being (SMD 0.44, 95% confidence interval (CI 0.13 to 0.75) and physical function (SMD 0.68, 95% CI 0.41 to 0.95) and possibly on pain (SMD 0.94, 95% CI -0.15 to 2.03) and tender points (SMD 0.26, 95% CI -0.28 to 0.79)." Results noted that flexibility and strength and flexibility remain under assessed. (Busch, Barber, Overend, Peloso, and Schachter, 2007, pp. 11-13)

According to criteria Melnyk Fineout-Overholt (2005) present, this study is a Level II study. From the Cochrane review, the following relates what research notes regarding the effect of exercise for FMS:

moderate intensity aerobic training for 12 weeks may improve overall well-being slightly and physical function.; moderate intensity aerobic exercise probably leads to little or no difference in pain or tender points.

A strength training for 12 weeks may result in large reductions in pain, tender points and depression, and large improvement in overall well-being but may not lead to any difference in physical function.

A the exercises programs that were studied were safe for most. The intensity of aerobic exercise training should be increased slowly aiming for a moderate level. If exercisers experience increased symptoms, they should cut back until symptoms improve. If in doubt about adverse effects, they should check with a health care professional.

A it is not known whether exercise training for more than 12 weeks improves other symptoms such as fatigue, stiffness or poor sleep.

It is not known whether flexibility training, programs combining types of exercise, and programs combining exercise with nonexercise strategies improve the symptoms of fibromyalgia. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 2)

The primary results of the review by Busch, Barber, Overend, Peloso, and Schachter (2007, pp. 13-14) includes the following:

Moderate quality evidence exists that aerobic-only exercise training at recommended intensity levels has medium-size positive effects on pain, small to medium-sized positive effects on global outcome measures and medium-sized positive effects on measures of physical function; the effect of such exercise on tender points is less certain but we cannot rule out the possibility that aerobic exercise has a large positive effect;

Strength and flexibility remain under-evaluated as exercise prescriptions for people with FMS;

Despite the increasing number of studies investigating the effect of combination treatments with exercise, this question has also received inadequate study, principally because there is underutilization of appropriate research designs;

There is limited evidence on a variety of other outcomes including stiffness, fatigue, and depression;

The analysis of percentage change reinforced the results of metaanalysis. In aerobics-only interventions, clinically significant improvements were found sporadically in six variables: depression, tender points, global well-being, physical function, self-efficacy and symptoms. (Busch, Barber, Overend, Peloso, and Schachter, 2007, pp. 13-14)

One particular strength noted in this study links to the reported "gold" level evidence (www.cochranemsk.org) thatwhen FM patients receive directed support to complete regular aerobic exercise training; the exercise efforts prove to produce positive effects on their physical capacity and FMS symptoms. (Busch, Barber, Overend, Peloso, and Schachter, 2007, p. 16) Several limitations included the fact that as a number of people with FMS experienced difficulty continuing an exercise program, no specific plans to ensure individuals exercise regularly were measured in these studies.

The researchers state that along with anticipated positive results from supervised regular aerobic exercise training, strength training may additionally contribute to benefits on numerous FMS symptoms.

Along with more research on long-term benefit of exercise for FMS, albeit, Busch, Barber, Overend, Peloso, and Schachter (2007, p. 17) recommend additional study relating to muscle strengthening and flexibility be conducted.

Study

During the second study reviewed, "A randomized clinical trial of an individualized home-based exercise programme (sic) for women with fibromyalgia, in their randomized clinical trial of an individualized home-based exercise program for women with fibromyalgia, conducted by Costal, Abrahamowicz, Lowensteyn, Bernatsky, Dritsa1, Fitzcharles, and Dobki (2005, p. 1422), the authors purposed to determine "the efficacy of a 12-week individualized home-based exercise program on physical functioning, pain severity and psychological distress for women with fibromyalgia (FM)." The research design utilized for this study consisted of the assessment of participants constituting a sample of seventy-nine women with a primary diagnosis of FM, "randomized to a 12-week individualized home-based moderate-intensity exercise programme (sic) or to a usual care control group." (Costal et al., 2005, p. 1422)

Researchers selected participants from two sources:

hospital or community rheumatologists, either directly or by invitation letters, and newspaper ads

Criteria for exclusion of participants included: "(i) concomitant diseases which precluded participation in exercise, (ii) contraindication to exercise identified by the examining physician, (iii) recent change in medication (in the previous 2 weeks) and (iv) regular participation in moderate-intensity exercise (more than 30 min three times per week) at the time of study entry." (Costal et al., 2005, p. 1422) to measure functional capacity, participants completed a "Fibromyalgia Impact Questionnaire" denoting their pain severity and psychological distress. For the procedure, researchers measured outcomes at initial study entry, at the end of the 12-week intervention, and again at three and nine months following completion of the intervention. A rheumatologist examined each consenting subject to confirm diagnosis of FM at study entry. Later, at nine months post-treatment, the same rheumatologist (blinded to randomization status) re-examined the participants. "Eligible participants completed a graded maximal exercise stress test, using the Bruce protocol [19] prior to randomization. This test was used to screen participants, determine baseline fitness and individualize the exercise prescription for participants assigned to the exercise group." Researchers evaluated participants' fitness via time on test, along with maximal metabolic equivalents (METs) capacity.

Results for this study indicate that following treatment, based on the intention-to-treat analyses, the participants who more functionally disabled in the exercise group at study entry experienced a significant improvement in functional capacity at three and nine months for participants. Outcomes for the female FM participants, compared with the control group at the end of the 12-week intervention, and at the three and none month intervals, after the intervention ended, noted statistically significant improvements in participants' upper body pain at post-treatment. The group of study participants, albeit, did not reveal any statistically significant differences regarding lower body pain and/or psychological distress. (Costal et al., 2005, p. 1422)

The key messages from this study, according to Costal et al. (2005, p. 1427) purport:

Home-based moderate intensity exercise improves upper body pain in womenwith fibromyalgia after 12-weeks and overall health status within 6 months of initiation.

The benefits observed were maintained at 9 months post-treatment.

The authors note that, as the primary outcome measures were obtained through participants' self reports, the occurrence of effects relating to subject expectancy cannot be ruled out. In addition, his study y did not include an attention control group.

This researcher purports that the fact the principal outcome measures were acquired through participants' self reports simultaneously serves as a strength and weakness. (Costal et al., 2005, p. 1426)

Study

The purpose of the prospective study, a series of randomized clinical trials (RCT), "Adherence During an Individualized Home-Based 12-Week Exercise Program in Women with Fibromyalgia," by Dobkin, Costa, Abrahamowicl, Dritsa, Du Rger, Fitzcharles, and Lowensteyn (2006) was to explore predictors for adherence to stretching and aerobic exercises in women with fibromyalgia. This study specifically aimed to:

identify predictors of uptake of stretching and aerobic exercises, and elucidate longitudinal changes in exercise, taking into account participants' baseline characteristics.

The research design included the provision of an individualized home-based program for each of the participants. For the procedure utilized in this study, 39 women (average age 49.2 years) recorded their progress in exercise diaries for 12 weeks. Participants recruited included women matching American College of Rheumatology criteria for a diagnosis of primary FM. Rheumatologists invited participants through letters, and they were also solicited through individuals working with FM patients followed at a hospital rheumatology clinic and/or community rheumatology practice, as well as through newspaper ads. Exclusion criteria for this study included (Dobkin, et al., 2006):

Concomitant diseases that precluded participation in an exercise program, contraindication to exercise identified by the examining physician, recent change in medication (prior 2 weeks), and regular participation in moderate intensity exercise (i.e., 3.0-6.0 MET, where one MET represents the metabolic activity of an individual at rest: 3.5 ml oxygen consumed per kg body mass per min, or about 1 kcal/kg/h) for at least 30 minutes, 3 times a week at the time of study entry. (Dobkin, et al., 2006)

Participants filled out an in-session questionnaire each weekly reporting whether they practiced respective interventions three or more times per week (yes/no). At the end of six weeks, researchers calculated a summary score for the consecutive weeks to determine adherence to the program. (Dobkin, et al., 2006)

Researchers reported each of the participant's pain intensity at baseline and then weekly during the 12-week training phase. Each of the participants related her pain intensity each week "on 100 mm VAS 24 in 6 areas: neck and shoulders, chest, upper/lower back, arms, buttocks, aid legs. End descriptors were 0 = no pain to 100 = severe pain," (Dobkin, et al., 2006) with the higher values denoting higher levels of pain. Researchers summed scores across body sites to yield total upper and total lower body pain intensity scores. VAS analyzes included fatigue, disturbed sleep, and global illness to examine the effect of symptoms on exercise engagement during ensuing weeks. The Weekly Stress Inventory (WS1), a self report instrument, assesses the frequency and stressfulness of minor stressors that participants experienced during each week. "This 87-item questionnaire asks respondents to indicate for each item whether the event occurred in the past week, and to rate the perceived stressfulness of the experienced event on a 7-point scale (1 = occurred but was not stressful, to 7 = extremely stressful)." (Dobkin, et al., 2006)

The WSI, designed to avoid problems such as items confounded with psychological distress symptoms, insensitivity to subtle fluctuations in stress levels, and contamination from retrospective reports, yields a Total WSI-Impact derived by summing the perceived stress ratings.

Results from this study relate that for stretching and aerobic exercises, women with fibromyalgia, who were less physically fit at baseline, "engaged in more exercise during the program. Yet for stretching, lower body pain at baseline predicted engaging in less stretching exercise over time, whereas for aerobic exercise, more baseline upper body pain predicted more exercise over time." (Dobkin, et al., 2006) in time older women or those who possessed higher baseline physical fitness reduced their aerobic exercise practice at significantly faster rates, than participants reporting higher baseline stress. In regard to depressive symptoms, the depression subscale of the Symptom checklist 90-R (SCL-90-R), a widely used measure validated with medical patients, assessed depressive symptoms at baseline.

The biofeedback group reflected best adherence. "The model that best explained 22% of the variance predicting adherence included the following variables: less depression, lower outcome expectancy, and more education, as well as interactions between the following: less self-efficacy and biofeedback group, less self-efficacy and exercise group, and age (older) and exercise group - indicating that in the exercise and biofeedback groups, older patients adhered more to their respective programs." The researchers did not examine changes in adherence over time were not examined. (Dobkin, et al., 2006) the authors admit that even though treatment recommendations for fibromyalgia (FM) include regular physical exercise, for this study, for both types of exercise, adequate levels of adherence proved to be limited to approximately half the participants. As no steps to reduce barriers to exercise (e.g., stress) were implemented, this study was not able to fully asses exercise results.

The authors stress that when exercise constitutes a part of the treatment of FM, clinician's need to incorporated steps to help patients implement to help them decrease exercise barriers, (Dobkin, et al., 2006) Dobkin, et al. (2006) report that at the end of their12-week study, "33 (84.6%) women still participated in the study protocol. For both types of exercise, the authors found, exercise duration initially increased, but then subsequently slightly declined. The most common type stressor, "time pressure," may be perceived as a barrier to engagement in exercise, the authors note.

One strength of this study, this author notes, is that it is reportedly the first to meticulously examine both uptake and persistence in exercise behaviors in women with FM. (Dobkin, et al., 2006) Other strengths of study 3 include the intensity of the data collection and the analytic techniques the authors used, which in turn, enabled them to examine changes over time and predict changes.

Their findings, albeit, invite questions as they are based on self-report, as noted in the quote introducing the Methodology section of this study: "self-report can be erroneous if the participant wants to be viewed positively by others, or if there is recall bias." (Dobkin, et al., 2006)

One limitation the authors admit, as no set criterion existed for them to compare the results (program varied across participants, as well as, over time), consequently, this researcher purports, the "global standard" participants were to reach, contributed to inconclusive results for the 12-week training phase.

Approximately half the participants, albeit, adhered to stretching exercising throughout the program, for stretching exercises, but fewer (about 40%) adhered to the aerobics regime. Another weakness, this researcher notes, is that women participants included only those willing to start an exercise program (no male participants) and consequently, did not adequately represent patients with FM.

Study

Most [patients with fibromyalgia] have impaired functional ability, reduced ability to sustain intensive exercise and low levels of aerobic fitness." (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 714) in the fourth study, "A Randomized, Controlled Clinical Trial of Education and Physical Training for Women with Fibromyalgia," published in. The Journal of Rheumatology, authored by Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, (1994, p. 714) set out to verify "the effectiveness of self-management education and physical training in decreasing fibromyalgia (FMS) symptoms and increasing physical and psychological well being."

The research design utilized for this study included a pretest-posttest control group design. For the participants, researchers solicited and randomly assigned 99 women with FMS to one of three groups. For the procedure, the "education only group received a 6-week self-management course. The education plus physical training group received the course and 6 h of training designed to assist them to exercise independently. The control group got treatment after 3 months." (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 714) Baseline comparisons were made between groups to look for pretreatment differences form computations of descriptive statistics of all variables in the study. (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 715) Initially, researchers screened 128 female patients physicians had diagnosed with FMS, using the 1990 criteria for classification of FIMS22 at the occupational health and primary health clinics in Gothenburg, Sweden, as potential participants for the study. These women must have experienced widespread pain in three of four quadrants of the body for longer than three months, along with, "at least 11 of 18 TP, normal results on the following laboratory tests: hemoglobin, free thyroxine, erythrocyte sedimentation rate (ESR), antinuclear antibodies, rheumatoid factor (RF), and creative phosphokinase, and no other rheumatic diseases." Of the 128 original potential participants, 99 were selected.

Out of the 99 selected to participated 86 women completed the study. The results note participants in the experimental programs experienced a significant positive impact on their quality of life and self-efficacy. When participants were retested six weeks after the end of the program, in one or both the treated groups, they reported that helplessness, number of days feeling bad, physical dysfunction, and pain in the tender points had significantly decreased significantly. Additionally, primarily in the physical training group, long-term follow-up of 67 treated subjects "showed significant positive changes on the Fibromyalgia Impact Questionnaire." (Burckhardt, Mannerkorpi, Hedenberg, and Bjelle, 1994, p. 714) at the end of the study by Burckhardt, Mannerkorpi, Hedenberg, and Bjelle (1994, p. 714), 87% of participants were exercising at least 3 times/week for at least 20 minutes, while 46% reported increased exercise levels since they began to participate in the program. Of the participants, 70% practiced relaxation strategies as needed, with 46% working at least half time, compared to 37% at pretest. The treated group of participants experienced significant, enhanced self-efficacy from their involvement in the program. Other changes, albeit, proved not as significant and arrived later than anticipated.