Long-term effectiveness and costs of a brief self-management intervention in women with pregnancy-related low back pain after delivery.

BACKGROUND: Pregnancy-related low back pain is considered an important health problem and potentially leads to long-lasting pain and disability. Investigators draw particular attention to biomedical factors but there is growing evidence that psychosocial and social factors might be important. It prompted us to start a large cohort study (n = 7526) during pregnancy until one year after delivery and a nested randomized controlled intervention study in the Netherlands. METHODS: A randomized controlled trial (n = 126) nested within a cohort study, of brief self-management techniques versus usual care for treatment of women with persisting non-specific pregnancy-related low back pain three weeks after delivery. Women in the intervention group were referred to a participating physiotherapist. Women in the usual care group were free to choose physiotherapy, guidance by a general practitioner or no treatment. Follow up took place at 3 months, 6 months and one year after delivery.Outcomes included change in limitations in activities (RDQ), pain (VAS), severity of main complaints (MC), global feeling of recovery (GPE), impact on participation and autonomy (IPA), pain-related fear (TSK), SF-36, EuroQol and a cost diary. For the outcome measures, series of mixed models were considered. For the outcome variable global perceived effect (GPE) a logistic regression analysis is performed. RESULTS: Intention-to-treat outcomes showed a statistical significant better estimated regression coefficient RDQ -1.6 {-2.9;-0.5} associated with treatment, as well as better IPA subscale autonomy in self-care -1.0 {-1.9;-0.03} and TSK -2.4 {-3.8;-1.1} but were not clinical relevant over time. Average total costs in the intervention group were much lower than in usual care, primarily due to differences in utilization of sick leave but not statistically significant. CONCLUSION: Brief self-management techniques applied in the first 3 months after delivery may be a more viable first-line approach but further research is needed to draw inference on costs and to determine whether no care is a better option in the long term. TRIAL REGISTRATION: [ISRCTN08477490].

Effectiveness of a tailor-made intervention for pregnancy-related pelvic girdle and/or low back pain after delivery: short-term results of a randomized clinical trial [ISRCTN08477490].

BACKGROUND: For the moment, scientific evaluation of programs on treatment of pregnancy-related pelvic girdle and/or low back pain after delivery is hardly available with only one study with a positive result, suggesting uncertainty about the optimal approach. Investigators draw particular attention to biomedical factors but there is growing evidence that biopsychosocial factors appear to be even more important as a basis of an intervention program. METHODS: We studied the effectiveness of a tailor-made program with respect to biopsychosocial factors (intervention group) in women with pregnancy-related pelvic girdle and/ or low back pain versus usual care based on a pain contingent basis (control group) shortly after delivery in a randomized controlled trial. Women with severe complaints shortly after delivery were selected from a longitudinal prospective cohort study (n = 7526), aimed at pregnancy-related pelvic girdle and/or low back pain in the Netherlands. A concealed block randomization was performed after collecting baseline data. Researchers were blinded to treatment assignment. Outcomes were evaluated within the domains of the biopsychosocial approach. Primary outcome concerned limitations in activities (RDQ). Follow-up measurements were performed 12 weeks after delivery. RESULTS: Since May 2001 until July 2003, 869 women out of the cohort made a request for treatment by a physiotherapist, 10 days after delivery. Because of a quick recovery in two weeks time, we included only 126 women three weeks after delivery. There was a statistically significant and clinically relevant difference in improvement on the primary outcome (RDQ) between the two groups in favor of the experimental intervention. CONCLUSION: The results favored the hypotheses. Women's worries about their condition were major targets in the experimental intervention. The prognosis after delivery, especially in de first weeks, turned out to be favorable.

Health care providers' orientations towards common low back pain predict perceived harmfulness of physical activities and recommendations regarding return to normal activity.

The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) differentiates between a biomedical versus a biopsychosocial treatment orientation with regard to common low back pain. This study re-examined the factor structure and psychometric properties of the PABS-PT, along with the relationship between PABS-PT scores and the perceived harmfulness of physical activities and treatment recommendations for common low back pain. Two hundred and ninety-seven paramedical therapists completed the PABS-PT and questionnaires measuring related concepts, rated the perceived harmfulness of 41 daily physical activities depicted in photographs and gave recommendations for return to normal activity for three patients with low back pain. Analysis revealed two factors labelled 'biomedical' and 'biopsychosocial treatment orientation'. Furthermore, scores on both factors of the PABS-PT were related to measures of related concepts (statistically significant Pearson correlation coefficients between 0.30 and 0.65) such as the HC-PAIRS and a therapist version of the TSK. Regression analyses revealed that both factors were consistent predictors of judgements of the harmfulness of physical activities (PHODA) and of recommendations for return to work and normal activity.

Health care providers' attitudes and beliefs towards common low back pain: factor structure and psychometric properties of the HC-PAIRS.

OBJECTIVE: The factor structure, reliability and validity of the Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) were determined in the current study. Furthermore, the ability of the HC-PAIRS to serve as a predictor for work and activity recommendations of paramedical health care providers was examined. DESIGN: For the current study, 156 therapists from several paramedical disciplines (mostly physiotherapy, manual therapy, chiropractic, and McKenzie) completed the HC-PAIRS and questionnaires measuring the perceived harmfulness of physical activities. Furthermore, the therapists gave recommendations for work and physical activity for patients described in vignettes. Since a factor structure was already known for the HC-PAIRS a confirmatory factor analysis was carried out. Reliability of the HC-PAIRS was determined by computing Cronbach's alpha. Validity was examined by reviewing associations between scores on the HC-PAIRS and scores on measures of the harmfulness of physical activities and recommendations for work and physical activity. Regression analyses were carried out to determine whether scores on the HC-PAIRS were a predictor of recommendations for work and physical activity while controlling for other variables. RESULTS: In contrast to previous research, factor analysis revealed only 1 factor and suggested that 2 items should be removed from the HC-PAIRS. This factor had a Cronbach's alpha of 0.84. The HC-PAIRS showed adequate validity. All associations between scores on the HC-PAIRS and scores on measures of the harmfulness of physical activities and recommendations for work and physical activity were in the expected directions and ranged between 0.25 and 0.62 (P < 0.01). Scores on the HC-PAIRS were the only significant predictor of recommendations for work and physical activity when controlling for possible confounders including gender, years of experience in the treatment of back pain, judgments of severity of symptoms, and judgments of severity of pathology. CONCLUSION: The HC-PAIRS appears to be a reliable and valid measure of health care providers' attitudes and beliefs about the relationship between pain and impairment. The role of health care providers' attitudes in the treatment of low back pain is discussed.

Treatment of pregnancy-related pelvic girdle and/or low back pain after delivery design of a randomized clinical trial within a comprehensive prognostic cohort study [ISRCTN08477490].

BACKGROUND: Pregnancy-related pelvic girdle and/or low back pain is a controversial syndrome because insight in etiology and prognosis is lacking. The controversy relates to factors eliciting pain and some prognostic factors such as the interpretation of pain at the symphysis. Recent research about treatment strategies also reflects those various opinions, in fact suggesting there is professional uncertainty about the optimal approach. Currently, physiotherapists often prescribe a pain-contingent treatment regime of relative rest and avoiding several day-to-day activities. Additionally, treatment more often includes an exercise program to guide rectification of the muscle imbalance and alignment of the pelvic girdle. Effectiveness of those interventions is not proven and the majority of the studies are methodologically flawed. Investigators draw particular attention to biomedical factors but there is growing evidence that important prognostic issues such as biopsychosocial factors appear to be even more important as point of action in a treatment program. METHODS/DESIGN: This pragmatic randomized controlled trial is designed to evaluate the effectiveness of a tailor-made treatment program with respect to biopsychosocial factors in primary care. The effect of the experimental intervention and usual care are evaluated as they are applied in primary health care. The trial is embedded in a cohort study that is designed as a longitudinal, prospective study, which studies prevalence, etiology, severity and prognosis during pregnancy until one year after delivery. The present paper focuses on choices regarding recruitment procedures, in-/exclusion criteria and the development of a well-timed intervention. DISCUSSION: This section briefly discusses the actions taken to minimize bias in the design, the proper time-window for the experimental intervention and the contrast between the experimental intervention and usual care.

Reproducibility and validity of the Dutch Life Habits Questionnaire (LIFE-H 3.0) in older adults.

OBJECTIVE: To examine the reproducibility, the discriminant and convergent validity and feasibility of the Dutch translation of the self-administered Life Habits Questionnaire (LIFE-H). DESIGN: Three cross-sectional community-based studies on clinimetric properties of a measurement instrument. SUBJECTS: Older adults (n=85) with functional limitations due to various chronic illnesses and healthy older adults (n=40). MEASUREMENT PROTOCOL: Participants of the reproducibility study (n=35) filled out the LIFE-H twice in a two-week time period. In the discriminant validity study (n=120), LIFE-H scores of healthy and ill subjects were compared. In the convergent validity study (n=63), correlations were examined between LIFE-H, the Impact on Participation and Autonomy questionnaire and the London Handicap Scale. RESULTS: The test-retest reliability showed a satisfactory intraclass correlation coefficient for the total overall score (0.80) but not for the categories scores. The discriminant validity study showed significant differences between the healthy and ill subjects for the 10 separate categories (P<0.01) and the total score (P<0.001). The correlations between the LIFE-H categories and total scores and the Impact on Participation and Autonomy Questionnaire (0.80-0.82) and London Handicap Scale (0.89-0.92) were strong. Feasibility testing showed that the subjects experienced difficulties due to the long and fairly complex instructions and structure of the LIFE-H. CONCLUSIONS: The clinimetric properties of the LIFE-H were moderate to good. The validity of LIFE-H was as good as the validity of the Impact on Autonomy and Participation and the London Handicap Scale, but the latter questionnaires were shorter and much easier to administer.

Behavioral graded activity following first-time lumbar disc surgery: 1-year results of a randomized clinical trial.

STUDY DESIGN AND OBJECTIVES: In a randomized clinical trial, the effectiveness of behavioral graded activity was assessed as compared to usual care provided by physiotherapists for patients after first-time lumbar disc surgery (n = 105). SUMMARY OF BACKGROUND DATA: Little is known about the effectiveness of rehabilitation programs following lumbar disc surgery. Most programs focus on biomechanical aspects, whereas psychosocial factors are hardly addressed. The aim of the behavioral graded activity program, which is an operant treatment, is to alter psycho-social factors such as fear of movement and pain catastrophizing, which might subsequently lead to improved functional status and higher rates of recovery. Behavioral treatments for patients following lumbar disc surgery have not yet been assessed in a randomized clinical trial. INCLUSION CRITERIA: age between 18 and 65 years; first-time lumbar disc surgery; restrictions in normal activities of daily living. EXCLUSION CRITERIA: surgical complications and confirmed and relevant underlying diseases. Outcome assessment took place at 6 and 12 months after randomization. RESULTS: Six months after randomization, 62% of the patients had recovered following usual care versus 65% of the patients following behavioral graded activity. After 12 months, 73% and 75%, respectively, had recovered. Differences between intervention groups, 3% and 2% respectively, after 6 and 12 months are not statistically significant. Furthermore, there were no differences between the two groups regarding functional status, pain, pain catastrophizing, fear of movement, range of motion, general health, social functioning or return to work. After 1 year, 4 of the behavioral graded activity cases had undergone another operation versus 2 of usual care cases. CONCLUSION: Both fear of movement and pain catastrophizing seem to be unaffected by either treatment in these patients. It is concluded that treatment principles derived from theories within the field of chronic low back pain might not apply to these patients. After 1 year of follow-up, there were no statistically significant or clinically relevant differences between the behavioral graded activity program and usual care as provided by physiotherapists for patients following first-time lumbar disc surgery.