ORIGINAL ARTICLE
Effectiveness of a Multimodal Treatment Program for Somatoform Pain Disorder Christoph Pieh, MD*,†; Susanne Neumeier, MD‡; Thomas Loew, MD*; J€ urgen ‡ § ¶ Altmeppen, MD ; Michael Angerer, MD ; Volker Busch, MD ; Claas Lahmann, MD** *Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Regensburg, Regensburg, Germany; †Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria; ‡Department of Anaesthesiology, Hospital Weiden, Weiden, Germany; §Department of Neurology, Hospital Weiden, Weiden, Germany; ¶ Department of Psychiatry and Psychotherapy, University Medical Centre Regensburg, Regensburg, Germany; **Department of Psychosomatic Medicine and Psychotherapy, Technische Universitaet Muenchen, Muenchen, Germany
& Abstract: Chronic pain conditions are highly prevalent, with somatoform pain disorder accounting for a large proportion. However, the psychological forms of treatment currently used achieve only small to medium effect sizes. This retrospective study investigated the effectiveness of a 5-week multimodal pain program for patients with somatoform pain disorder. The diagnosis of somatoform pain disorder was confirmed by a specialist for anesthesiology and pain management and a specialist for psychosomatic medicine. Therapy outcome was evaluated with a Numeric Rating Scale (NRS), the Pain Disability Index (PDI), and the Pain Perception Scale. Within the study sample (n = 100), all parameters showed a significant and clinically relevant improvement at the end of therapy (P values < 0.001). The highest effect sizes (d) were found for reduction in average pain rating (NRS: d = 1.00) and the affective items of the Pain Perception Scale (SES-A: d = 0.07). The lowest effect sizes were found for improvement of pain-related disabilities (PDI: d = 0.42) and sensory items of the Pain Perception Scale (SES-S: d = 0.50).
Address correspondence and reprint requests to: Christoph Pieh, MD, Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Dr.-Karl-Dorrek-Straße 30, 3500 Krems, Austria. E-mail: [email protected]. Submitted: June 06, 2013; Revision accepted: September 16, 2013 DOI. 10.1111/papr.12144
© 2013 World Institute of Pain, 1530-7085/14/$15.00 Pain Practice, Volume 14, Issue 3, 2014 E146–E151
Despite high chronification of pain condition, with average pain duration of greater than 8 years, the multimodal treatment program showed medium to large effect sizes on the outcome of patients with somatoform pain disorder. Compared with previous data with small to moderate effect sizes, a multimodal program seems to be more effective than other interventions to address somatoform pain disorder. & Key Words: somatic symptom disorder, somatoform disorder, cognitive behavioral therapy, multimodal treatment, medically unexplained symptoms
INTRODUCTION Medically unexplained symptoms are highly prevalent in both the general population and clinical samples, with pain constituting the most significant cluster among these complaints. Hessel and colleagues focused on medically unexplained pain symptoms and surveyed a representative sample of 2,050 persons in Germany; they reported the following prevalence rates: 30% back pain, 25% joint pain, 20% pain in legs and/or arms, and 20% headache.1 Persistent (> 6 months), severe, and distressing pain that is not fully explained by a physical disorder and leading to preoccupation of the pain symptoms could be classified as persistent somatoform pain disorder
Multimodal Treatment for Somatoform Disorder E147
according to the ICD-10 criteria.2 Besides pain in different locations, specific functional complaints such as dizziness, fatigue, or symptoms related to autonomous arousal are common, and the rate of co-morbid depressive and/or anxiety disorders is high.3 The underlying mechanisms of somatoform pain disorder are still not completely clarified. Psychodynamic-interpersonal models particularly emphasize interpersonal processes, as well as impaired body awareness and self-regulation, already at work in childhood,4 with adverse childhood events leading to an increased rate of somatoform pain complaints.5,6 In addition to traumatic life experiences, gender, socioeconomic status, and education level seem to influence somatoform pain disorder onset and course.7,8 Cognitive-behavioral models focus on the phenomenon of somatosensory amplification,9 which means that due to an interceptive perception style, normal physical sensations tend to be perceived more intensely and are interpreted as signs of a somatic illness.10 Because of the patient’s strong belief in an underlying somatic illness, they frequently seek further somatic diagnostics and therapy. This frequently leads to multiple but ineffective therapeutic attempts, resulting in patient frustration and a difficult doctor–patient relationship. Neurobiological research focuses on altered neural pain perception processes; decreased activation of empathetic-affective networks was found in patients with medically unexplained symptoms.11 Medically unexplained physical symptoms such as experienced in somatoform pain are difficult and costly to treat.12 These patients frequently hold negative views of both pharmacotherapy and psychotherapy.13 Despite the epidemiological and economic importance of somatoform pain disorders, there is only very limited evidence regarding efficacious treatment from clinical trials. Cognitive behavioral therapy (CBT) is an effective treatment for patients with somatization or symptom syndromes and therefore the best-established treatment for a variety of somatoform disorders.14 Kroenke and colleagues reported that effective treatments have indeed been established for somatoform disorders in general, but not for conversion and somatoform pain disorder.15 However, the treatment effect (standardized mean difference) ranges from 0.38 to 0.12 and is rather small.16 A meta-analysis showed small levels of efficacy for psychotherapy, and the authors concluded that combined treatments should be examined.12 From a clinical point of view, multimodal pain therapy, which means integrated multidisciplinary treatment in small
groups with a closely coordinated therapeutic approach, is recommended in chronic pain syndromes.17 Therefore, we conducted a retrospective clinical study evaluating the effects of a multimodal treatment program for outpatients with persistent somatoform pain disorder.
METHODS Ethical Considerations This retrospective study was planned and conducted in adherence to Good Clinical Practice and appropriate use of informed consent, as defined by the International Conference on Harmonisation (ICH). The Institutional Review Board (IRB) granted exemption. All participants signed a consensus declaration and agreed to the analysis of their anonymous data. Inclusion Criteria (1) Patients (> 18 years) with a somatoform pain disorder according to the ICD-10 criteria,2 (2) providing written informed consent, (3) participation in and completion of the multimodal program (see treatment), and (4) no other psychiatric disorder. Diagnostics Prior to treatment, every patient was examined by a specialist for psychosomatic medicine and psychotherapy and a specialist for anesthesiology and pain management. Psychiatric examination was based on a standardized semi-structured psychiatric interview according to the ICD-10 symptom checklist for mental disorders. Treatment A 5-week multimodal pain treatment program included treatment by physicians, psychologists, physical therapists, a nutritionist, a social worker, and relaxation therapists. The daily outpatient program lasted from Monday to Friday (8:00 a.m. to 4:00 p.m.) and consisted of individual treatment, as well as standardized group therapy. An average of 8 patients was included in each group. The psychosomatic treatment consisted of 1 hour per week of individual therapy and 6 hours per week of group psychotherapy. The main modules of the CBT group program were (1) acceptance, (2) resource
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development, (3) conflict management and interpersonal skills training, (4) implementation in daily life, and (5) relapse prevention. The individual therapy focused on each patient’s specific impairment. The group treatment was standardized with a manual and was conducted four times a week for 90 minutes each. The multimodal treatment program also included physical therapy (8 hours per week), relaxation techniques (3.5 hours per week), counseling for chronic pain (2 hours per week), nutrition advice, and social counseling (each 1 hour per week). Measurement At the beginning and end of the pain treatment program, the following self-rating instruments were used to assess pain and resulting disabilities:
The Numeric Rating Scale (NRS) is an 11-point numeric scale, scored 0 (no pain) through 10 (worst possible pain) to rate minimum, average, and maximum pain within the past 4 weeks.18,19 The NRS is a valid and reliable method of measuring pain, which is recommended for use in patients with chronic pain.20 The validated German version of the Pain Disability Index (PDI)21,22 is an instrument to assess pain-related disabilities. The respondent rates the degree to which pain interferes with functioning from 0 (no disability) to 10 (total disability) in seven broad areas: family/home, responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity. The Pain Perception Scale (SES) determines sensory and affective pain qualities. Every item is scored from 0 (not appropriate) to 3 (fully appropriate).23 Allgemeine Depressionsskala (ADS) is the German version of the Centre for Epidemiological Studies Depression Scale, which is a validated, self-rating instrument that measures the presence and duration of depressive symptoms.24,25
usage, and life-time use of the health care system.28 Because disability pension is thought to influence therapy outcome,29 the patient’s statement as to whether he or she had applied for such assistance was documented. Medication There is consensus that nonpharmacological treatment approaches are preferable to drug treatment for somatoform disorders.30 Due to their documented lack of efficiency in somatoform pain, peripheral analgesics were not prescribed or were stepwise reduced. Depending on the patient’s comorbidities, co-analgesic medication with antidepressants or mood stabilisers was implemented. As the termination of all peripheral analgesics was not possible during the program, the release medication for nonopioid analgesics (eg, nonsteroidal anti-inflammatory drugs), opiates, and coanalgesics (eg, tricyclic antidepressants or anticonvulsant drugs) was documented. Statistics SPSSâ 18.0 (SPSS Inc., Chicago, IL., U.S.A.) was used for all statistical analyses. Two-tailed significance level was set at 0.05. For multiple testing adjustments, we utilized Bonferroni corrections and adjusted the significance level to 0.007. All variables were tested for normal distribution with Kolmogorov–Smirnov tests. Mean values and standard deviations are presented as descriptive statistics, and cross-tables were used for frequencies in the case of ordinal variables. For pre- and post-treatment comparison, we performed paired t-tests or Wilcoxon tests depending on the normality of the distribution. Therapy outcome was defined as the baseline minus the final values. The effect size (Cohen’s d) was determined as the mean difference of scores divided by the pretreatment standard deviation. We performed a correlation analysis (Pearson) to quantitate the benefit of ADS benefit on pain variables.
RESULTS Pain Chronicity Stage The validated Mainz Pain Staging System (MPSS) was used to determine pain chronicity stage and was collected at the beginning of treatment.26,27 The MPSS distinguishes three pain stages (from 1 to 3), considering temporal and spatial dimensions of pain, medication
Among the patients (n = 103) that started the therapy, three quit early and were excluded from the analysis. Overall, 100 patients fulfilled the inclusion criteria (study sample), and their characteristics are presented in Table 1. The average pain duration before treatment was 100 (83) months, and 82 patients met the criteria for pain stage 3 of pain chronicity staging (MPSS).
Multimodal Treatment for Somatoform Disorder E149
Table 1. Study Sample Study sample Age (years) M (SD) Pain duration (month) M (SD) Sex Female Male Pain chronicity stage (MPSS) 1 2 3 Overall Psychiatric comorbidities (according to ICD-10) F1 F3 F6 Education 13 years Overall Unknown Job situation Working Applied for disability pension Retired Unknown
48.9 (9.1) 100.0 (83.4) 57 43 1 15 82 98 11 68 4 2 68 2 8 80 20
patients took opiates, and 47 patients received coanalgesics. Baseline and end values and improvement and effect size (d) for pain (NRS, SES), pain-related disabilities (PDI), and depression (ADS) are presented in Table 2. All investigated parameters showed significant improvements (P values < 0.001) through therapy with medium to large effect sizes: The highest effect sizes were found for reduction in average pain (NRS, d = 1.00) and the affective items of the Pain Perception Scale (SES-A, d = 0.7). The lowest effect sizes were found in improvement of pain-related disabilities (PDI, d = 0.42), minimum pain (NRS, d = 0.47) and sensory items of the Pain Perception Scale (SES-S, d = 0.50). The ADS benefit was significantly correlated with improvement of the affective items of the SES (Pearson’s, r = 0.40, P < 0.001). There were no correlations with ADS improvement and the other investigated parameters.
37 22 13 28
Because of severe chronification of pain symptoms, only one patient met the criteria for pain stage 1 (MPSS). There was a female predominance (57%) of the study sample, as well as a high percentage of comorbid affective disorders (68%). All patients received peripheral analgesics for their chronic pain conditions before treatment. At the end of the multimodal program, 58 (58%) patients still received analgesics, and multiple prescriptions were common. Within the 58 patients who received analgesics, 15 patients received nonopioid analgesics, 44
DISCUSSION Despite average pain duration of more than 8 years before treatment, the multimodal program showed medium to large effect sizes on the outcomes of patients with somatoform pain disorder. However, the improvement differed for the investigated pain parameters. The highest benefit with a large effect size of d = 1.0 was seen in average pain perception (NRS). In comparison, the improvement in pain-related disabilities (PDI) was considerably smaller (d = 0.4), which may be explained by the chronicity of pain conditions. There was a reduction in depressive symptoms (d = 0.5) as a consequence of the treatment. However, as there was no correlation with the majority of the
Table 2. Patient Outcomes Baseline Value M SD (n) PDI ADS SES affective SES sensory
NRS minimum NRS average NRS maximum
40.87 31.65 42.47 27.46
(13.0) (11.3) (9.4) (8.7)
End Value M SD (n) 35.42 25.53 35.84 23.08
(14.2) (12.3) (11.3) (7.5)
Improvement 5.45 6.12 6.63 4.38
Baseline Value M SD (n)
End Value M SD (n)
Improvement
5.24 (2.3) 7.46 (1.6) 8.90 (1.2)
4.17(2.3) 5.86 (2.0) 8.18 (1.77)
1.07 1.60 0.72
d
T
df
0.42 0.54 0.71 0.50
5.062 6.166 5.896 5.369
90 93 95 94
d 0.47 1.00 0.60
Z 4.250 6.087 3.336
P < < <
8 years) corresponding with the high pain chronicity stages of the study sample, the effects were even more remarkable. Compared with previous data with small to moderate effect sizes,15 a multimodal program seems to be more effective than other interventions to address somatoform pain disorder. Further studies should focus on multimodal therapy to improve the treatment for this highly prevalent patient population.
REFERENCES 1. Hessel A, Beutel M, Geyer M, Schumacher J, Br€ ahler E. Prevalence of somatoform pain complaints in the German population. GMS Psycho-Soc-Med. 2005;2:1–10. 2. Dilling H, Mombour W, Schmidt MH, eds. International Classification of Mental and Behavioural Disorders, 5th ed. Bern: Huber; 2008. 3. Pieh C, Lahmann C, Heymann F, et al. Prevalence and comorbidity of somatoform disorder in psychosomatic inpatients: a multicentre study. Z Psychosom Med Psychother. 2011;57:244–250. 4. Sattel H, Lahmann C, G€ undel H, et al. Brief psychodynamic interpersonal psychotherapy for patients with multisomatoform disorder: randomised controlled trial. Br J Psychiatry. 2012;200:60–67. 5. Sack M, Lahmann C, Jaeger B, Henningsen P. Trauma prevalence and somatoform symptoms: are there specific somatoform symptoms related to traumatic experiences? J Nerv Ment Dis. 2007;195:928–933. 6. Paras M, Murad M, Chen L. et a. Sexual abuse and lifetime diagnosis of somatic disorders: a systematic review and meta-analysis. JAMA. 2009;302:550–561. 7. Kroenke K, Spitzer R. Gender differences in the reporting of physical and somatoform symptoms. Psychosom Med. 1998;60:150–155. 8. Gale CR, Deary IJ, Cooper C, Batty GD. Intelligence in childhood and chronic widespread pain in middle age: The National Child Development Survey. Pain. 2012;153:2339– 2344. 9. Lahmann C, Henningsen P, Dinkel A. Somatoform disorders and functional somatic syndromes. Nervenarzt. 2010;81:1383–1394.
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10. Nickel R, Ademmer K, Egle U. Manualized psychodynamic-interactional group therapy for the treatment of somatoform pain disorders. Bull Menninger Clin. 2010;74:219– 237. 11. Noll-Hussong M, Otti A, Wohlschlaeger A, et al. Neural correlates of deficits in pain-related affective meaning construction in patients with chronic pain disorder. Psychosom Med. 2013;75:124–136. 12. Kleinst€auber M, Witth€ oft M, Hiller W. Efficacy of short-term psychotherapy for multiple medically unexplained physical symptoms: a meta-analysis. Clin Psychol Rev. 2011;31:146–160. 13. Balon R. Cognitive-behavioral therapy, psychotherapy and psychosocial interventions in the medically ill. Psychother Psychosom. 2009;78:261–264. 14. Kroenke K, Swindle R. Cognitive-behavioral therapy for Somatization and Symptom Syndromes: a critical review of controlled clinical trials. Psychother Psychosom. 2000;69:205–215. 15. Kroenke K. Efficacy of treatment for somatoform disorders: a review of randomized controlled trials. Psychosom Med. 2007;69:881–888. 16. Schaefert R, Hausteiner-Wiehle C, H€auser W, Ronel J, Herrmann M, Henningsen P. Non-specific, functional, and somatoform bodily complaints. Dtsch Arztebl Int. 2012;109:803–813. 17. Arnold B, Brinkschmidt T, Casser HR, et al. Multimodal pain therapy: principles and indications. Schmerz. 2009;23:112–120. 18. Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990;17:1022–1034. 19. Jensen MP, Turner JA, Romano J, Fisher L. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999;83:157–162. 20. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1996;27:117–126.
21. Tait R, Chibnall J, Krause S. The Pain Disability Index: psychometric properties. Pain. 1990;40:171–182. 22. Dillmann U, Nilges P, Saile H, Gerbershagen HU. Assessing disability in chronic pain patients. Schmerz. 1994;8:100–110. 23. Geissner E. The Pain Perception Scale (SES). G€ ottingen: Hogrefe; 1996. 24. Hautzinger M, Bailer M. Allgemeine Depressions Skala. G€ ottingen: Beltz Test GmbH; 1993. 25. Markush R, Favero R. Epidemiologic assessment of stressful life events, depressed mood, and psychophysiological symptoms: A preliminary report. In: Dohrenwend BS, Dohrenwend BP, eds. Stressful Life Events: Their Nature and Effects. New York: John Wiley and Sons; 1973. 26. Gerbershagen HU. The Mainz Pain Staging System. Vienna: Arachne; 1998:71–95. 27. Frettloh J, Maier C, Gockel H, Huppe M. Validation of the German Mainz Pain Staging System in different pain syndromes. Schmerz. 2003;17:240–251. 28. Gerbershagen HU, Lindena G, Korb J, Kramer S. Health-related quality of life in patients with chronic pain. Schmerz. 2002;16:271–284. 29. Becker N, Højsted J, Sjøgren P, Eriksen J. Sociodemographic predictors of treatment outcome in chronic nonmalignant pain patients. Do patients receiving or applying for disability pension benefit from multidisciplinary pain treatment? Pain. 1998;77:279–287. 30. Henningsen P, Zipfel S, Herzog W. Management of functional somatic syndromes. Lancet. 2007;369:946–955. 31. Schaefert R, Kaufmann C, Wild B, et al. Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial. Psychother Psychosom. 2013;82:106– 119. 32. Arnold B, H€ auser W, Arnold M, et al. Multicomponent therapy of fibromyalgia syndrome. Systematic review, meta-analysis and guideline. Schmerz. 2012;26:287–290.
Effectiveness of a Multimodal Treatment Program for Somatoform Pain Disorder Christoph Pieh, MD*,†; Susanne Neumeier, MD‡; Thomas Loew, MD*; J€ urgen ‡ § ¶ Altmeppen, MD ; Michael Angerer, MD ; Volker Busch, MD ; Claas Lahmann, MD** *Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Regensburg, Regensburg, Germany; †Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria; ‡Department of Anaesthesiology, Hospital Weiden, Weiden, Germany; §Department of Neurology, Hospital Weiden, Weiden, Germany; ¶ Department of Psychiatry and Psychotherapy, University Medical Centre Regensburg, Regensburg, Germany; **Department of Psychosomatic Medicine and Psychotherapy, Technische Universitaet Muenchen, Muenchen, Germany
& Abstract: Chronic pain conditions are highly prevalent, with somatoform pain disorder accounting for a large proportion. However, the psychological forms of treatment currently used achieve only small to medium effect sizes. This retrospective study investigated the effectiveness of a 5-week multimodal pain program for patients with somatoform pain disorder. The diagnosis of somatoform pain disorder was confirmed by a specialist for anesthesiology and pain management and a specialist for psychosomatic medicine. Therapy outcome was evaluated with a Numeric Rating Scale (NRS), the Pain Disability Index (PDI), and the Pain Perception Scale. Within the study sample (n = 100), all parameters showed a significant and clinically relevant improvement at the end of therapy (P values < 0.001). The highest effect sizes (d) were found for reduction in average pain rating (NRS: d = 1.00) and the affective items of the Pain Perception Scale (SES-A: d = 0.07). The lowest effect sizes were found for improvement of pain-related disabilities (PDI: d = 0.42) and sensory items of the Pain Perception Scale (SES-S: d = 0.50).
Address correspondence and reprint requests to: Christoph Pieh, MD, Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Dr.-Karl-Dorrek-Straße 30, 3500 Krems, Austria. E-mail: [email protected]. Submitted: June 06, 2013; Revision accepted: September 16, 2013 DOI. 10.1111/papr.12144
© 2013 World Institute of Pain, 1530-7085/14/$15.00 Pain Practice, Volume 14, Issue 3, 2014 E146–E151
Despite high chronification of pain condition, with average pain duration of greater than 8 years, the multimodal treatment program showed medium to large effect sizes on the outcome of patients with somatoform pain disorder. Compared with previous data with small to moderate effect sizes, a multimodal program seems to be more effective than other interventions to address somatoform pain disorder. & Key Words: somatic symptom disorder, somatoform disorder, cognitive behavioral therapy, multimodal treatment, medically unexplained symptoms
INTRODUCTION Medically unexplained symptoms are highly prevalent in both the general population and clinical samples, with pain constituting the most significant cluster among these complaints. Hessel and colleagues focused on medically unexplained pain symptoms and surveyed a representative sample of 2,050 persons in Germany; they reported the following prevalence rates: 30% back pain, 25% joint pain, 20% pain in legs and/or arms, and 20% headache.1 Persistent (> 6 months), severe, and distressing pain that is not fully explained by a physical disorder and leading to preoccupation of the pain symptoms could be classified as persistent somatoform pain disorder
Multimodal Treatment for Somatoform Disorder E147
according to the ICD-10 criteria.2 Besides pain in different locations, specific functional complaints such as dizziness, fatigue, or symptoms related to autonomous arousal are common, and the rate of co-morbid depressive and/or anxiety disorders is high.3 The underlying mechanisms of somatoform pain disorder are still not completely clarified. Psychodynamic-interpersonal models particularly emphasize interpersonal processes, as well as impaired body awareness and self-regulation, already at work in childhood,4 with adverse childhood events leading to an increased rate of somatoform pain complaints.5,6 In addition to traumatic life experiences, gender, socioeconomic status, and education level seem to influence somatoform pain disorder onset and course.7,8 Cognitive-behavioral models focus on the phenomenon of somatosensory amplification,9 which means that due to an interceptive perception style, normal physical sensations tend to be perceived more intensely and are interpreted as signs of a somatic illness.10 Because of the patient’s strong belief in an underlying somatic illness, they frequently seek further somatic diagnostics and therapy. This frequently leads to multiple but ineffective therapeutic attempts, resulting in patient frustration and a difficult doctor–patient relationship. Neurobiological research focuses on altered neural pain perception processes; decreased activation of empathetic-affective networks was found in patients with medically unexplained symptoms.11 Medically unexplained physical symptoms such as experienced in somatoform pain are difficult and costly to treat.12 These patients frequently hold negative views of both pharmacotherapy and psychotherapy.13 Despite the epidemiological and economic importance of somatoform pain disorders, there is only very limited evidence regarding efficacious treatment from clinical trials. Cognitive behavioral therapy (CBT) is an effective treatment for patients with somatization or symptom syndromes and therefore the best-established treatment for a variety of somatoform disorders.14 Kroenke and colleagues reported that effective treatments have indeed been established for somatoform disorders in general, but not for conversion and somatoform pain disorder.15 However, the treatment effect (standardized mean difference) ranges from 0.38 to 0.12 and is rather small.16 A meta-analysis showed small levels of efficacy for psychotherapy, and the authors concluded that combined treatments should be examined.12 From a clinical point of view, multimodal pain therapy, which means integrated multidisciplinary treatment in small
groups with a closely coordinated therapeutic approach, is recommended in chronic pain syndromes.17 Therefore, we conducted a retrospective clinical study evaluating the effects of a multimodal treatment program for outpatients with persistent somatoform pain disorder.
METHODS Ethical Considerations This retrospective study was planned and conducted in adherence to Good Clinical Practice and appropriate use of informed consent, as defined by the International Conference on Harmonisation (ICH). The Institutional Review Board (IRB) granted exemption. All participants signed a consensus declaration and agreed to the analysis of their anonymous data. Inclusion Criteria (1) Patients (> 18 years) with a somatoform pain disorder according to the ICD-10 criteria,2 (2) providing written informed consent, (3) participation in and completion of the multimodal program (see treatment), and (4) no other psychiatric disorder. Diagnostics Prior to treatment, every patient was examined by a specialist for psychosomatic medicine and psychotherapy and a specialist for anesthesiology and pain management. Psychiatric examination was based on a standardized semi-structured psychiatric interview according to the ICD-10 symptom checklist for mental disorders. Treatment A 5-week multimodal pain treatment program included treatment by physicians, psychologists, physical therapists, a nutritionist, a social worker, and relaxation therapists. The daily outpatient program lasted from Monday to Friday (8:00 a.m. to 4:00 p.m.) and consisted of individual treatment, as well as standardized group therapy. An average of 8 patients was included in each group. The psychosomatic treatment consisted of 1 hour per week of individual therapy and 6 hours per week of group psychotherapy. The main modules of the CBT group program were (1) acceptance, (2) resource
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development, (3) conflict management and interpersonal skills training, (4) implementation in daily life, and (5) relapse prevention. The individual therapy focused on each patient’s specific impairment. The group treatment was standardized with a manual and was conducted four times a week for 90 minutes each. The multimodal treatment program also included physical therapy (8 hours per week), relaxation techniques (3.5 hours per week), counseling for chronic pain (2 hours per week), nutrition advice, and social counseling (each 1 hour per week). Measurement At the beginning and end of the pain treatment program, the following self-rating instruments were used to assess pain and resulting disabilities:
The Numeric Rating Scale (NRS) is an 11-point numeric scale, scored 0 (no pain) through 10 (worst possible pain) to rate minimum, average, and maximum pain within the past 4 weeks.18,19 The NRS is a valid and reliable method of measuring pain, which is recommended for use in patients with chronic pain.20 The validated German version of the Pain Disability Index (PDI)21,22 is an instrument to assess pain-related disabilities. The respondent rates the degree to which pain interferes with functioning from 0 (no disability) to 10 (total disability) in seven broad areas: family/home, responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity. The Pain Perception Scale (SES) determines sensory and affective pain qualities. Every item is scored from 0 (not appropriate) to 3 (fully appropriate).23 Allgemeine Depressionsskala (ADS) is the German version of the Centre for Epidemiological Studies Depression Scale, which is a validated, self-rating instrument that measures the presence and duration of depressive symptoms.24,25
usage, and life-time use of the health care system.28 Because disability pension is thought to influence therapy outcome,29 the patient’s statement as to whether he or she had applied for such assistance was documented. Medication There is consensus that nonpharmacological treatment approaches are preferable to drug treatment for somatoform disorders.30 Due to their documented lack of efficiency in somatoform pain, peripheral analgesics were not prescribed or were stepwise reduced. Depending on the patient’s comorbidities, co-analgesic medication with antidepressants or mood stabilisers was implemented. As the termination of all peripheral analgesics was not possible during the program, the release medication for nonopioid analgesics (eg, nonsteroidal anti-inflammatory drugs), opiates, and coanalgesics (eg, tricyclic antidepressants or anticonvulsant drugs) was documented. Statistics SPSSâ 18.0 (SPSS Inc., Chicago, IL., U.S.A.) was used for all statistical analyses. Two-tailed significance level was set at 0.05. For multiple testing adjustments, we utilized Bonferroni corrections and adjusted the significance level to 0.007. All variables were tested for normal distribution with Kolmogorov–Smirnov tests. Mean values and standard deviations are presented as descriptive statistics, and cross-tables were used for frequencies in the case of ordinal variables. For pre- and post-treatment comparison, we performed paired t-tests or Wilcoxon tests depending on the normality of the distribution. Therapy outcome was defined as the baseline minus the final values. The effect size (Cohen’s d) was determined as the mean difference of scores divided by the pretreatment standard deviation. We performed a correlation analysis (Pearson) to quantitate the benefit of ADS benefit on pain variables.
RESULTS Pain Chronicity Stage The validated Mainz Pain Staging System (MPSS) was used to determine pain chronicity stage and was collected at the beginning of treatment.26,27 The MPSS distinguishes three pain stages (from 1 to 3), considering temporal and spatial dimensions of pain, medication
Among the patients (n = 103) that started the therapy, three quit early and were excluded from the analysis. Overall, 100 patients fulfilled the inclusion criteria (study sample), and their characteristics are presented in Table 1. The average pain duration before treatment was 100 (83) months, and 82 patients met the criteria for pain stage 3 of pain chronicity staging (MPSS).
Multimodal Treatment for Somatoform Disorder E149
Table 1. Study Sample Study sample Age (years) M (SD) Pain duration (month) M (SD) Sex Female Male Pain chronicity stage (MPSS) 1 2 3 Overall Psychiatric comorbidities (according to ICD-10) F1 F3 F6 Education 13 years Overall Unknown Job situation Working Applied for disability pension Retired Unknown
48.9 (9.1) 100.0 (83.4) 57 43 1 15 82 98 11 68 4 2 68 2 8 80 20
patients took opiates, and 47 patients received coanalgesics. Baseline and end values and improvement and effect size (d) for pain (NRS, SES), pain-related disabilities (PDI), and depression (ADS) are presented in Table 2. All investigated parameters showed significant improvements (P values < 0.001) through therapy with medium to large effect sizes: The highest effect sizes were found for reduction in average pain (NRS, d = 1.00) and the affective items of the Pain Perception Scale (SES-A, d = 0.7). The lowest effect sizes were found in improvement of pain-related disabilities (PDI, d = 0.42), minimum pain (NRS, d = 0.47) and sensory items of the Pain Perception Scale (SES-S, d = 0.50). The ADS benefit was significantly correlated with improvement of the affective items of the SES (Pearson’s, r = 0.40, P < 0.001). There were no correlations with ADS improvement and the other investigated parameters.
37 22 13 28
Because of severe chronification of pain symptoms, only one patient met the criteria for pain stage 1 (MPSS). There was a female predominance (57%) of the study sample, as well as a high percentage of comorbid affective disorders (68%). All patients received peripheral analgesics for their chronic pain conditions before treatment. At the end of the multimodal program, 58 (58%) patients still received analgesics, and multiple prescriptions were common. Within the 58 patients who received analgesics, 15 patients received nonopioid analgesics, 44
DISCUSSION Despite average pain duration of more than 8 years before treatment, the multimodal program showed medium to large effect sizes on the outcomes of patients with somatoform pain disorder. However, the improvement differed for the investigated pain parameters. The highest benefit with a large effect size of d = 1.0 was seen in average pain perception (NRS). In comparison, the improvement in pain-related disabilities (PDI) was considerably smaller (d = 0.4), which may be explained by the chronicity of pain conditions. There was a reduction in depressive symptoms (d = 0.5) as a consequence of the treatment. However, as there was no correlation with the majority of the
Table 2. Patient Outcomes Baseline Value M SD (n) PDI ADS SES affective SES sensory
NRS minimum NRS average NRS maximum
40.87 31.65 42.47 27.46
(13.0) (11.3) (9.4) (8.7)
End Value M SD (n) 35.42 25.53 35.84 23.08
(14.2) (12.3) (11.3) (7.5)
Improvement 5.45 6.12 6.63 4.38
Baseline Value M SD (n)
End Value M SD (n)
Improvement
5.24 (2.3) 7.46 (1.6) 8.90 (1.2)
4.17(2.3) 5.86 (2.0) 8.18 (1.77)
1.07 1.60 0.72
d
T
df
0.42 0.54 0.71 0.50
5.062 6.166 5.896 5.369
90 93 95 94
d 0.47 1.00 0.60
Z 4.250 6.087 3.336
P < < <
8 years) corresponding with the high pain chronicity stages of the study sample, the effects were even more remarkable. Compared with previous data with small to moderate effect sizes,15 a multimodal program seems to be more effective than other interventions to address somatoform pain disorder. Further studies should focus on multimodal therapy to improve the treatment for this highly prevalent patient population.
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