Dataset Information

Expectations influence treatment outcomes in patients with low back pain. A secondary analysis of data from a randomized clinical trial.

ABSTRACT:

Background

Low back pain (LBP) is a global public health challenge, which causes high healthcare costs and the highest burden on society in terms of years lived with disability. While patients' expectations for improvement may have effects on LBP treatment outcomes, it remains unclear if psychological profiles modify this relationship. Therefore, the objectives of this study were to investigate if (a) patients' expectations predicted short-term outcome, and (b) psychological profile, pain intensity and self-rated health modified the relationship between expectations and outcome.

Methods

Data were collected between April 2012 and January 2016 during the inclusion into a randomized controlled trial. Potentially eligible participants were identified through 40 chiropractic clinics located across Sweden. Patients' expectations, psychological profile, pain intensity, activity limitation and self-rated health were collected from patients with recurrent persistent LBP during their first chiropractic visit (n = 593). Subjective improvement was measured at the fourth visit.

Results

Patients with a high expectation of improvement had 58% higher risk to report an improvement at the fourth visit (RR = 1.58, 95% CI: 1.28, 1.95). Controlling for potential confounders only slightly decreased the strength of this association (RR = 1.49, 95% CI: 1.20, 1.86). Baseline pain intensity, psychological profile and self-rated health did not modify the effect of expectation on outcome.

Conclusions

Baseline patients' expectations play an important role when predicting LBP treatment outcomes. Clinicians should consider and address patients' expectations at the first visit to best inform prognosis.

Significance

This study confirms the importance of patients' expectations in a clinical setting. Patients' expectations predict the short-term outcome of chiropractic care for LBP. Pain intensity, psychological profile and self-rated health did not modify this relationship.

SUBMITTER: Eklund A

PROVIDER: S-EPMC6767754 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Expectations influence treatment outcomes in patients with low back pain. A secondary analysis of data from a randomized clinical trial.

Eklund Andreas A De Carvalho Diana D Pagé Isabelle I Wong Arnold A Johansson Melker S MS Pohlman Katherine A KA Hartvigsen Jan J Swain Michael M

European journal of pain (London, England) 20190520 7

<h4>Background</h4>Low back pain (LBP) is a global public health challenge, which causes high healthcare costs and the highest burden on society in terms of years lived with disability. While patients' expectations for improvement may have effects on LBP treatment outcomes, it remains unclear if psychological profiles modify this relationship. Therefore, the objectives of this study were to investigate if (a) patients' expectations predicted short-term outcome, and (b) psychological profile, pai ...[more]

PMID: 31034102

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Project description:BackgroundPain hypersensitivity can be assessed using Quantitative Sensory Testing (QST) and is associated with persistent low back pain. Spinal manipulation appears to modify pain hypersensitivity, and this could function as one mechanism leading to clinical improvements. In the current study, we applied a comprehensive QST battery to assess pain sensitivity in a cohort of low back pain patients before and after spinal manipulation to improve our understanding of the association between QST and clinical improvements. This study addresses two questions: Are clinical improvements following spinal manipulation in low back pain patients contingent on pain hypersensitivity, and does pain sensitivity change following spinal manipulation?MethodsWe performed a secondary analysis of data from a randomized clinical trial. One hundred and thirty-two participants with persistent LBP were treated with spinal manipulation four times over two weeks. Patient-reported outcomes and QST were assessed at baseline, after the fourth spinal manipulation session, and 14-days later. The clinical outcomes were changes in low back pain intensity and disability. Using latent profile analysis, we categorized the participants into clusters depending on their baseline QST scores. We used linear mixed models to examine the association between clusters and changes in patient-reported outcomes and QST.ResultsTwo clusters emerged: a Sensitized and a Not sensitized. The former had significantly lower regional pressure and thermal pain thresholds, remote pressure pain tolerance, and lower inhibitory conditioned pain modulation than the Not sensitized group. However, we only found between-cluster differences for regional pressure pain threshold following spinal manipulation. Thus, the clusters were not associated with patient-reported pain and disability changes or the remaining QST outcomes.ConclusionsWe report that the baseline QST profile was not associated with clinical improvements following spinal manipulation. We did observe a substantial change for regional pressure pain threshold, which suggests that any effect of spinal manipulation on pain sensitivity is most likely to be observed as changes in regional, mechanical pain threshold. However, the mechanism that invokes clinical improvement and pain sensitivity changes appear distinct. Due to methodological caveats, we advise caution when interpreting the results.Trial registrationClinical.Trial.gov identifier: NCT04086667 , registered 11 September 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04086667.

Project description:ImportanceIn observational studies, patients' treatment outcome expectations have been associated with better outcomes (ie, a placebo response), whereas concerns about adverse side effects have been associated with an in increase in the negative effects of treatments (ie, a nocebo response). Some randomized trials have suggested that communication from clinicians could affect the treatment outcomes by changing patients' expectations.ObjectiveTo investigate whether treatment outcome expectations and reported adverse side effects could be affected by different briefing contents before a minimal acupuncture treatment in patients with chronic low back pain (CLBP).Design, setting, and participantsThis randomized single-blinded clinical trial was conducted among patients with CLBP at 1 outpatient clinic in Switzerland who had a pain intensity of at least 4 on a numeric rating scale from 0 to 10. Different recruitment channels were used to enroll patients. Data were collected from May 2016 to December 2017 and were analyzed from June to November 2018.InterventionsPatients were randomized to receive either a regular expectation briefing or a high expectation briefing (effectiveness) and either a regular adverse side effect briefing or an intense adverse side effect briefing (adverse side effect) in a 2 × 2 factorial design. The intervention (briefing sessions and written materials) was standardized and delivered before the acupuncture treatment, with additional booster informative emails provided during the 4-week, 8-session acupuncture course.Main outcomes and measuresThe primary end point was the patients' expectations regarding the effectiveness of the acupuncture treatment (Expectation for Treatment Scale [ETS]) after the briefing and the subsequent pain intensity (numeric rating scale). The primary end point for the adverse side effect briefing was the adverse side effect score at the end of the acupuncture treatment, derived from session-by-session assessments of adverse side effects.ResultsA total of 152 patients with CLBP (mean [SD] age, 39.54 [12.52] years; 100 [65.8%] women) were included. The estimated group difference (regular vs high) for the ETS was -0.16 (95% CI -0.81 to 0.50, P = .64), indicating no evidence for a difference between intervention groups. There was also no evidence for a difference in pain intensity at the end of the acupuncture treatment between the groups with different expectation briefings. The adverse side effects score in the group with the intense adverse side effect briefing were estimated to be 1.31 times higher (95% CI, 0.94 to 1.82; P = .11) than after a regular adverse side effect briefing, but the finding was not statistically significant.Conclusions and relevanceIn this study, suggestions regarding treatment benefits (placebo) and adverse side effects (nocebo) did not affect treatment expectations or adverse side effects. Information regarding adverse side effects might require more research to understand nocebo responses.Trial registrationGerman Clinical Trials Register Identifier: DRKS00010191.

Project description:ObjectiveChronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain.MethodsThis study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes.ResultsSixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01).ConclusionsNaturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain.Trial registrationControlled-Trials.com ISRCTN41920953.

Project description:BackgroundPoor sleep is common among adults with chronic low back pain (cLBP), but the influence of cLBP treatments, such as yoga and physical therapy (PT), on sleep quality is under studied.ObjectiveEvaluate the effectiveness of yoga and PT for improving sleep quality in adults with cLBP.DesignSecondary analysis of a randomized controlled trial.SettingAcademic safety-net hospital and 7 affiliated community health centers.ParticipantsA total of 320 adults with cLBP.InterventionTwelve weekly yoga classes, 1-on-1 PT sessions, or an educational book.Main measuresSleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI) global score (0-21) at baseline, 12 weeks, and 52 weeks. Additionally, we also evaluated how the proportion of participants who achieved a clinically meaningful improvement in sleep quality (> 3-point reduction in PSQI) at 12 weeks varied by changes in pain and physical function at 6 weeks.Key resultsAmong participants (mean age = 46.0, 64% female, 82% non-white), nearly all (92%) reported poor sleep quality (PSQI > 5) at baseline. At 12 weeks, modest improvements in sleep quality were observed among the yoga (PSQI mean difference [MD] = - 1.19, 95% confidence interval [CI] - 1.82, - 0.55) and PT (PSQI MD = - 0.91, 95% CI - 1.61, - 0.20) groups. Participants who reported a ≥ 30% improvement in pain or physical function at 6 weeks, compared with those who improved < 10%, were more likely to be a sleep quality responder at 12 weeks (odds ratio [OR] = 3.51, 95% CI 1.73, 7.11 and OR = 2.16, 95% CI 1.18, 3.95, respectively). Results were similar at 52 weeks.ConclusionIn a sample of adults with cLBP, virtually all with poor sleep quality prior to intervention, modest but statistically significant improvements in sleep quality were observed with both yoga and PT. Irrespective of treatment, clinically important sleep improvements at the end of the intervention were associated with mid-intervention pain and physical function improvements.Trial registrationClinicalTrials.gov Identifier: NCT01343927.

Project description:The purpose of this secondary analysis was 1) to examine patient expectations related to a variety of common interventions for low back pain (LBP) and 2) to determine the influence that specific expectations about spinal manipulation might have had on self-report of disability.We collected patients' expectations about the benefit of specific interventions for low back pain. We also collected patients' general expectations about treatment and tested the relationships among the expectation of benefit from an intervention, receiving that intervention and disability-related outcomes.Patients expected exercise and manual therapy interventions to provide more benefit than surgery and medication. There was a statistical association between expecting relief from thrust techniques and receiving thrust techniques, related to meeting the general expectation for treatment (chi-square: 15.5, P ?=? 0.008). This was not the case for patients who expected relief from thrust techniques but did not receive it (chi-square: 6.9, P ?=?0.4). Logistic regression modeling was used to predict change in disability at treatment visit 5. When controlling for whether the general expectations for treatment were met, intervention assignment and the interaction between intervention assignment and expectations regarding thrust techniques, the parsimonious model only included intervention as the significant contributor to the model (P < 0.001). The adjusted odds ratio of success comparing thrust techniques to non-thrust in this study was 41.2 (11.0, 201.7).The findings of this secondary analysis indicate that patients seeking intervention for LBP expect active interventions and manual therapy to significantly help improve their pain more than interventions like traction, rest, surgery, or medication. Additionally, in patients who meet the clinical prediction rule for good prognosis when managed with thrust techniques, treating with thrust techniques is more important than matching treatment to patient expectation.

Project description:ImportanceAntidepressants at low dose are commonly prescribed for the management of chronic low back pain and their use is recommended in international clinical guidelines. However, there is no evidence for their efficacy.ObjectiveTo examine the efficacy of a low-dose antidepressant compared with an active comparator in reducing pain, disability, and work absence and hindrance in individuals with chronic low back pain.Design, setting, and participantsA double-blind, randomized clinical trial with a 6-month follow-up of adults with chronic, nonspecific, low back pain who were recruited through hospital/medical clinics and advertising was carried out.InterventionLow-dose amitriptyline (25 mg/d) or an active comparator (benztropine mesylate, 1 mg/d) for 6 months.Main outcomes and measuresThe primary outcome was pain intensity measured at 3 and 6 months using the visual analog scale and Descriptor Differential Scale. Secondary outcomes included disability assessed using the Roland Morris Disability Questionnaire and work absence and hindrance assessed using the Short Form Health and Labour Questionnaire.ResultsOf the 146 randomized participants (90 [61.6%] male; mean [SD] age, 54.8 [13.7] years), 118 (81%) completed 6-month follow-up. Treatment with low-dose amitriptyline did not result in greater pain reduction than the comparator at 6 (adjusted difference, -7.81; 95% CI, -15.7 to 0.10) or 3 months (adjusted difference, -1.05; 95% CI, -7.87 to 5.78), independent of baseline pain. There was no statistically significant difference in disability between the groups at 6 months (adjusted difference, -0.98; 95% CI, -2.42 to 0.46); however, there was a statistically significant improvement in disability for the low-dose amitriptyline group at 3 months (adjusted difference, -1.62; 95% CI, -2.88 to -0.36). There were no differences between the groups in work outcomes at 6 months (adjusted difference, absence: 1.51; 95% CI, 0.43-5.38; hindrance: 0.53; 95% CI, 0.19-1.51), or 3 months (adjusted difference, absence: 0.86; 95% CI, 0.32-2.31; hindrance: 0.78; 95% CI, 0.29-2.08), or in the number of participants who withdrew owing to adverse events (9 [12%] in each group; χ2 = 0.004; P = .95).Conclusions and relevanceThis trial suggests that amitriptyline may be an effective treatment for chronic low back pain. There were no significant improvements in outcomes at 6 months, but there was a reduction in disability at 3 months, an improvement in pain intensity that was nonsignificant at 6 months, and minimal adverse events reported with a low-dose, modest sample size and active comparator. Although large-scale clinical trials that include dose escalation are needed, it may be worth considering low-dose amitriptyline if the only alternative is an opioid.Trial registrationanzctr.org.au Identifier: ACTRN12612000131853.

Project description:Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines.This study evaluated the efficacy of a mobile-Web intervention called "FitBack" to help users implement self-tailored strategies to manage and prevent NLBP occurrences.A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments.Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain.This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users' preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement.Clinicaltrials.gov NCT01950091; http://clinicaltrials.gov/ct2/show/NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77).

Dataset Information

Expectations influence treatment outcomes in patients with low back pain. A secondary analysis of data from a randomized clinical trial.

Background

Methods

Results

Conclusions

Significance

Publications

Expectations influence treatment outcomes in patients with low back pain. A secondary analysis of data from a randomized clinical trial.

Similar Datasets

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