Author Response to "The Therapeutic Alliance May Yet Prove Effective".

Author response to the JOSPT Letter to the Editor-in-Chief "The Therapeutic Alliance May Yet Prove Effective" J Orthop Sports Phys Ther 2021;51(10):527-528. doi:10.2519/jospt.2021.0203-R.

Education With Therapeutic Alliance Did Not Improve Symptoms in Patients With Chronic Low Back Pain and Low Risk of Poor Prognosis Compared to Education Without Therapeutic Alliance: A Randomized Controlled Trial.

OBJECTIVES: To compare the effectiveness of an education intervention with or without the addition of the therapeutic alliance to no education intervention in patients with nonspecific chronic low back pain (LBP) and low risk of poor prognosis. DESIGN: Randomized controlled trial. Randomization was performed using randomly generated numbers. METHODS: Two hundred twenty-two patients with nonspecific chronic LBP and low risk of poor prognosis from 2 university physical therapy services in Taubaté, Brazil were randomized into 3 groups: education plus therapeutic alliance, education only, and no education. Primary outcomes were pain (measured with the numeric pain-rating scale) and patient-specific disability (measured with the Patient-Specific Functional Scale), assessed 1 month after randomization. The patients, therapists, and assessors were not blinded due to the nature of the intervention and self-reported outcomes. RESULTS: Patients were recruited between November 2015 and February 2017. There was a loss of 17 (7.6%) follow-up assessments at 1 month, 28 (12.6%) at 6 months, and 31 (13.9%) at 12 months after randomization, and intention-to-treat analyses were conducted. There were no significant differences in pain between groups. However, there was a significant improvement in patient-specific disability for the education-plus-therapeutic alliance and education-only groups compared to no education after 1 month (mean difference, -1.41; 95% confidence interval: -2.31, -0.51 and -0.95; 95% confidence interval: -1.85, -0.04, respectively). CONCLUSION: An education intervention did not provide clinically relevant improvements in patient-specific disability and did not influence pain in patients with nonspecific chronic LBP and low risk of poor prognosis. Additionally, there was no difference between interventions with or without emphasis on the therapeutic alliance. J Orthop Sports Phys Ther 2021;51(8):392-400. Epub 7 May 2021. doi:10.2519/jospt.2021.9636.

Translation, Cross-cultural Adaptation to Brazilian Portuguese, and Analysis of Measurement Properties of the Consultation and Relational Empathy Measure.

OBJECTIVE: The purpose of this study was to translate, cross-culturally adapt to Brazilian Portuguese, and analyze the measurement properties of the Consultation and Relational Empathy (CARE) Measure and investigate whether empathy can be a predictor of clinical improvement. METHODS: This psychometric study was divided into 2 stages: the cross-cultural adaptation process included 30 patients, and the evaluation of the measurement properties included 106 patients with chronic musculoskeletal pain. After the third therapy session with the same physical therapist, the following questionnaires were applied to assess internal consistency, construct validity, and ceiling and floor effects: Pain Numerical Rating Scale, Brazilian Portuguese version of the CARE Measure (CARE-Br), MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care, and Global Perceived Effect Scale. To assess reliability and measurement error, the CARE-Br was answered 48 hours later. For prediction analysis of the CARE-Br in relation to clinical improvement, the participants answered the Pain Numerical Rating Scale and Global Perceived Effect Scale 2 months after baseline. RESULTS: The internal consistency was adequate (Cronbach's ɑ = 0.88), reliability was substantial (intraclass correlation coefficient = 0.77), measurement error was good (standard error of the measurement = 5.16%), and a moderate correlation was found with the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (r = 0.50). A ceiling effect was also found (39.6% of participants). Empathy was not considered a predictor of clinical improvement. CONCLUSION: The Brazilian Portuguese version of the CARE Measure is reliable, adequate, and applicable in clinical settings and research in Brazil. However, it is not capable of predicting clinical improvement in patients with chronic musculoskeletal pain.

Revisão sistemática sobre exercício no tratamento da dor lombar e pélvica gestacional / Systematic review about exercise in the treatment of pregnancy related lumbar/pelvic pain

Introdução: Várias revisões sistemáticas já foram realizadas com o objetivo de verificar o efeito de tratamentos combinados na melhora da dor lombar e pélvica gestacional. Porém, o efeito da terapia por exercícios no tratamento da dor lombar e pélvica gestacional ainda é incerto. Objetivos: Revisar as evidências de estudos controlados aleatorizados (ECAs) acerca da terapia por exercício na dor, incapacidade, recuperação e saúde geral em mulheres com dor lombar e pélvica gestacional. Métodos: Buscas foram realizadas no MEDLINE, EMBASE, CINAHL, CENTRAL e PEDro em fevereiro de 2018. Algumas palavras-chave utilizadas foram: randomized controlled trial, low back pain e exercise therapy. Apenas ECAs de mulheres com dor lombar e pélvica gestacional foram selecionados, cujo tratamento foi baseado em terapia por exercícios. Os estudos foram analisados de forma descritiva. Resultados: Pela análise dos 21 artigos elegíveis, não se pode confirmar que os exercícios são superiores ao não-tratamento, à intervenção mínima/cuidados usuais, e outros tipos de tratamento para dor lombar e pélvica gestacional. Essa limitação deve-se à grande heterogeneidade dos estudos elegíveis. Conclusão: Há evidência escassa e de baixa qualidade metodológica para a utilização de exercícios no tratamento da dor lombar e pélvica gestacional.

Introduction: Several systematic reviews have already been performed with the aim of verifying the effect of combined treatments on the improvement of gestational low back and pelvic pain. However, the effect of exercise therapy in the treatment of gestational low back and pelvic pain is still unclear. Objectives: To review the evidence from randomized controlled trials (RCTs) of exercise therapy on pain, disability, recovery and overall health in women with gestational low back and pelvic pain. Methods: Searches were conducted on MEDLINE, EMBASE, CINAHL, CENTRAL and PEDro in February 2018. Some keywords used were randomized controlled trial, low back pain and exercise therapy. Only RCTs of women with gestational low back and pelvic pain were selected, whose treatment was based on exercise therapy. Studies were analyzed descriptively. Results: Analyzing the 21 eligible studies, we may not confirm that exercises are superior to no treatment, minimal intervention/usual care, and other types of treatment for gestational low back and pelvic pain. This limitation is due to the high heterogeneity between the eligible studies. Conclusion: Evidence with good methodological quality is scarce for the use of exercises in the treatment of gestational low back and pelvic pain.

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial).

BACKGROUND: The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of the therapeutic alliance to a minimal intervention may be an option for the treatment of low back pain. This paper reports on the rationale, design and protocol for a randomized controlled trial with blind assessor to assess the effectiveness of the addition of therapeutic alliance with minimal intervention on pain and disability in patients with chronic, nonspecific low back pain. METHODS: Two hundred and twenty-two patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors will be assessed and randomly allocated into three groups (n = 74 patients per group). The Positive Therapeutic Alliance group will receive counseling and guidance with an emphasis on therapeutic alliance and empathy. The Usual Treatment group will receive the same information and counseling with limited interaction with the therapist. The Control group will not receive any intervention. The treatment will be composed by two intervention sessions with a 1-week interval. A blinded assessor will collect the following outcomes at baseline, 1 month, 6 months and 12 months after randomization: pain intensity (Pain Numerical Rating Scale), specific disability (Patient-specific Functional Scale), general disability (Oswestry Disability Index), global perceived effect (Global Perceived Effect Scale), empathy (Consultation and Relational Empathy Measure), credibility and expectations related to treatment. The analysis will be performed using linear mixed models. DISCUSSION: This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice (minimal intervention). The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back pain. TRIAL REGISTRATION: ClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015.

Análise eletromiográfica de músculos da coluna vertebral durante a marcha em diferentes formas de carregar o bebê / Electromyographic analysis of the spinal muscles during the gait in different ways to carry a baby

Introdução: A forma de carregar o bebê pode causar desequilíbrios em músculos relacionados à coluna vertebral. Objetivos: Investigar a atividade elétrica dos músculos trapézio fibras descendentes e eretores lombares durante a marcha na simulação de carregar um bebê. Métodos: 20 voluntárias, destras e saudáveis participaram das coletas durante a marcha em esteira na simulação do ato de carregar o bebê em diferentes formas: 1) posição horizontal; 2) posição vertical; 3) suporte tipo "canguru" e 4) suporte tipo "sling". Os resultados eletromiográficos foram analisados pela análise da intensidade do sinal eletromiográfico dos músculos trapézio fibras descendentes e eretores espinhais lombares bilateralmente. Resultados: A ANOVA de dois fatores indicou que a forma de carregar (F(4,59)=17,1 p<0,001) e lado (F(1, 59)=89,6 p<0,001) afetaram a intensidade da atividade do músculo eretor espinhal e também a forma de carregar (F(4, 59)=6,4 p<0,001) e lado (F(1, 59)=59,9 p<0,001) do músculo trapézio fibras descendentes. Conclusões: O suporte canguru gerou menor ativação em músculos espinhais durante a quando comparado a outras situações.

Introduction: The way to carry the baby may cause imbalances in muscles related to the spine. Objectives: To investigate the electrical activity of the muscles trapezius descending fibers and lumbar erector during the simulation of carrying a baby. Methods: 20 volunteers right-handed and healthy participate of the study during walking on a treadmill to simulate the act of carrying the baby in different ways: 1) horizontal position; 2) vertical position; 3) Support Type "kangaroo" and 4) Support Type "sling". The EMG results were analyzed by analysis of the intensity of the electromyographic signal of the muscles trapezius fibers descendants and spinal lumbar erector bilaterally. Results: A two-way ANOVA indicated that the way of loading (F(4, 59)=17.1 p <0,001) and next (F(1, 59)=89.6 p <0.001) affected the intensity of the activity spinal erector muscles and also the way of loading (F(4, 59)=6.4 p <0.001) and next (F(1, 59)=59.9 p <0.001) of the trapezius muscle fibers descendants. Conclusions: Kangaroo support generated less activation in spinal muscles during when compared to other situations.

Örebro Musculoskeletal Pain Screening Questionnaire Short-Form and STarT Back Screening Tool: Correlation and Agreement Analysis.

STUDY DESIGN: Correlation and agreement analysis. OBJECTIVE: The objective of this study was to compare the Brazilian Portuguese versions of the Örebro Musculoskeletal Pain Screening Questionnaire Short-Form (ÖMPSQ-short) and the STarT Back Screening Tool (SBST)-Brazil in patients with low back pain and to verify their correlation with disability, kinesiophobia, and pain. SUMMARY OF BACKGROUND DATA: The ÖMPSQ-short and the SBST were designed to identify patients at risk of developing pain and disability related to psychosocial factors. METHODS: We assessed 130 patients, who answered the ÖMPSQ-short, SBST-Brazil, Roland-Morris disability questionnaire, Tampa scale of kinesiophobia, and Pain Numerical Rating scale. The total scores of the ÖMPSQ-short and the SBST-Brazil were correlated with the other questionnaires. Cross-tabulation and Cohen κ were used to analyze the agreement between the ÖMPSQ-short and the SBST-Brazil for participant classification as low or high risk for involvement of psychosocial factors. RESULTS: The ÖMPSQ-short and the SBST-Brazil presented good correlation between total scores (r = 0.73), good correlation with disability (ÖMPSQ-short: r = 0.72; SBST-Brazil: r = 0.76), and kinesiophobia (ÖMPSQ-short: r = 0.68; SBST-Brazil: r = 0.60) and moderate correlation with pain in the last episode (ÖMPSQ-short: r = 0.39; SBST-Brazil: r = 0.48), in last 2 weeks (ÖMPSQ-short: r = 0.39; SBST: r = 0.43), and current pain (ÖMPSQ-short: r = 0.39; SBST-Brazil: r = 0.31). Participant classification as high or low risk by the two questionnaires showed moderate agreement (κ = 0.49). A total of 83% of participants were classified correctly by the two questionnaires. CONCLUSION: The ÖMPSQ-short and the SBST-Brazil showed good correlation between total scores and moderate agreement for patient classification in relation to the presence of psychosocial factors. LEVEL OF EVIDENCE: 3.

Örebro Questionnaire: short and long forms of the Brazilian-Portuguese version.

PURPOSE: To translate, cross-culturally adapt and test the measurement properties of the Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) short and long versions in Brazilian-Portuguese. METHODS: The ÖMPSQ versions were translated, cross-culturally adapted and pretested in 30 patients with acute and subacute non-specific low back pain. Internal consistency, reproducibility (reliability and agreement), construct validity, and ceiling and floor effects were tested in 100 patients. Construct validity was assessed using the Roland-Morris Disability Questionnaire (RMDQ), the Tampa Scale for Kinesiophobia (TSK), and the Pain Numerical Rating Scale. RESULTS: Internal consistency was adequate (ÖMPSQ: Cronbach's alpha = 0.83; ÖMPSQ-short: Cronbach's alpha = 0.72). Reliability was substantial (ÖMPSQ: ICC2,1 0.76; ÖMPSQ-short: 0.78). Standard error of measurement was very good for the ÖMPSQ (5 %) and good for the ÖMPSQ-short (6.7 %); limits of agreement were 13.07 for the ÖMPSQ and 1.37 for the ÖMPSQ-short; and the minimum detectable change was 25.12 for the ÖMPSQ and 15.51 for the ÖMPSQ-short. The ÖMPSQ total score showed a good correlation with the RMDQ (r = 0.73) and the TSK (r = 0.64) and a moderate correlation with pain intensity (current pain: r = 0.36; last 2 weeks: r = 0.37; last episode: r = 0.46). Moreover, ÖMPSQ-short showed a good correlation with RMDQ (r = 0.69) and a moderate correlation with TSK (r = 0.57) and pain (current pain: r = 0.34; last 2 weeks: r = 0.36; last episode: r = 0.54). No ceiling or floor effects were detected in both versions. CONCLUSION: The Brazilian-Portuguese ÖMPSQ and ÖMPSQ-short showed acceptable measurement properties and provide evidence that the Brazilian-Portuguese versions of ÖMPSQ and ÖMPSQ-short are similar to the original versions.

Evaluation of cross-cultural adaptation and measurement properties of breast cancer-specific quality-of-life questionnaires: a systematic review.

PURPOSE: To assess the procedures of translation, cross-cultural adaptation, and measurement properties of breast cancer-specific quality-of-life questionnaires. METHODS: Searches were conducted in the databases MEDLINE, EMBASE, CINAHL, and SciELO using the keywords: "Questionnaires," "Quality of life," and "Breast cancer." The studies were analyzed in terms of methodological quality according to the guidelines for the procedure of cross-cultural adaptation and the quality criteria for measurement properties of questionnaires. RESULTS: We found 24 eligible studies. Most of the articles assessed the translation and measurement properties of the instrument EORTC QLQ-BR23. Description about translation and cross-cultural adaptation was incomplete in 11 studies. Translation and back translation were the most tested phases, and synthesis of the translation was the most omitted phase in the articles. Information on assessing measurement properties was provided incompletely in 23 articles. Internal consistency was the most tested property in all of the eligible articles, but none of them provided information on agreement. Construct validity was adequately tested in only three studies that used the FACT-B and QLQ-BR23. Eight articles provided information on reliability; however, only four found positive classification. Responsiveness was tested in four articles, and ceiling and floor effects were tested in only three articles. None of the instruments showed fully adequate quality. CONCLUSION: There is limited evidence on cross-cultural adaptations and measurement properties; therefore, it is recommended that caution be exercised when using breast cancer-specific quality-of-life questionnaires that have been translated, adapted, and tested.