ABSTRACT
OBJECTIVE: The purpose of this study was to evaluate the feasibility of a randomized controlled trial investigating the effectiveness of a multimodal program (PAT-Back) compared to best practice advice on pain and disability in older adults with chronic low back pain (LBP) in primary care. METHODS: This feasibility study took place in Fortaleza, Northeast Brazil. The PAT-Back intervention consisted of a program including exercises, pain education, and motivational text messages for the in-home component. The control group received an evidence-based educational booklet. Feasibility outcomes were recruitment, adherence and retention rates, level of difficulty of the education and intervention content, perception of utility of mobile technology, and adverse events. The feasibility criteria were previously defined. RESULTS: A total of 248 people were screened, of which 46 older adults were eligible. The retention rate was high (100% in the PAT-Back group and 95% in the control group). The adherence rate to intervention was partially met (60%), whereas the adherence rate to unsupervised exercises was adequate (75%), and perception about safety to perform home exercise was partially acceptable (70%) in the PAT-Back group. In addition, 100% of older adults reported which text messages motivated them to perform the exercises in the PAT-Back group. Difficulty reported by participants in understanding and performing the intervention was small in both groups. Six participants reported transient adverse events in both groups. CONCLUSION: Older adults accepted both interventions. Results demonstrated that the program is feasible, although minor changes targeting adherence and safety in home exercise are needed. IMPACT: This feasibility study supports progression to a full trial investigating the effectiveness of a multimodal program (PAT-Back) on pain and disability in older adults with chronic LBP within a primary health care setting in low to middle income countries where such data from the older population are scarce and the burden of LBP is increasing.
Subject(s)
Low Back Pain , Text Messaging , Humans , Aged , Feasibility Studies , Exercise , Exercise Therapy/methods , Low Back Pain/therapyABSTRACT
ABSTRACT BACKGROUND AND OBJECTIVES Low back pain is the leading cause of disability in Brazil. Most of the evidence on interventions for chronic low back pain (CLBP) comes from high income countries. The objective was to investigate the feasibility of conducting a program based in exercise and pain education in Primary Health Care supported by low-cost mobile technology for adults with CLBP (versus waiting list) and to explore the profile of patients who adhered compared to those who did not adhere. METHODS This is a feasibility study with adult residents of Fortaleza, Brazil with CLBP. The Intervention Group consisted of strategies such as physical exercises, pain education, phone calls and support messages to participants. The Control Group was based on a waiting list. Primary outcomes included retention and adherence rates, comprehension of the intervention, credibility, and satisfaction with the intervention. Secondary outcomes included clinical and demographic factors such as pain intensity, disability, recovery prognosis, and physical activity, described according to adherence behavior. RESULTS Forty-five individuals were allocated to the Intervention Group and 24 to the Control Group. Overall, 57.8% of participants adhered to the intervention. Retention rates were 53.33% and 58.3% for intervention and control, respectively. The other primary feasibility outcomes were satisfactory. Longer time spent sitting and level of schooling differed the profile of those who adhered to the intervention from those who did not. Higher pain intensity and poorer recovery prognosis, measured at baseline, influenced non-adherence to home exercises. CONCLUSION The feasibility of the protocol was adequate for the comprehension of the components, however, adherence to the protocol and the follow-up of the participants were low. The profile of individuals adhering to the intervention includes higher schooling and more time spent sitting at baseline. Characteristics such as higher pain intensity and the influence of psychosocial factors influenced non-adherence to home exercises. Brazilian Registry of Clinical Trials (REBEC RBR-5wqr2j).
RESUMO JUSTIFICATIVA E OBJETIVOS A dor lombar é a principal causa de incapacidade no Brasil. A maior parte da evidência sobre intervenções para dor lombar crônica (DLC) advém de países desenvolvidos. O objetivo deste estudo foi investigar a viabilidade de conduzir um programa baseado em exercícios e educação em dor na Atenção Primária à Saúde para adultos com DLC (versus lista de espera) e explorar o perfil dos pacientes que aderiram comparado aos que não aderiram à intervenção. MÉTODOS Este é um estudo de viabilidade. Foram incluídos adultos com DLC e residentes em Fortaleza, CE, no Brasil. O Grupo Intervenção foi composto por estratégias como exercícios físicos, educação em dor, ligações telefônicas e mensagens de suporte aos participantes. O Grupo Controle consistiu em lista de espera. Os desfechos primários incluíram taxas de retenção e adesão, entendimento da intervenção, credibilidade e satisfação com a intervenção. Os desfechos secundários incluíram fatores clínicos e demográficos, como intensidade de dor, incapacidade, prognóstico de recuperação e atividade física, descritos segundo comportamento de adesão. RESULTADOS Quarenta e cinco indivíduos foram alocados para o Grupo Intervenção e 24 para o Grupo Controle. Em geral, 57,8% dos participantes aderiram à intervenção. As taxas de retenção foram 53,33% e 58,3% para intervenção e controle, respectivamente. Os demais desfechos primários de viabilidade foram satisfatórios. Maior tempo sentado e o grau de instrução diferiam o perfil dos aderentes dos não aderentes à intervenção. Maior intensidade de dor e pior prognóstico de recuperação, mensurados na avaliação, influenciaram a não adesão aos exercícios domiciliares. CONCLUSÃO A viabilidade do protocolo apresentou-se adequada para entendimento dos componentes. Entretanto, a adesão ao protocolo e o seguimento dos participantes foram baixos. O perfil dos indivíduos aderentes à intervenção incluiu maior instrução e mais tempo sentado na sua avaliação inicial. Características como maior intensidade de dor e influência de fatores psicossociais influenciaram a não adesão aos exercícios domiciliares. Registro Brasileiro de Ensaios Clínicos (REBEC RBR-5wqr2j).
ABSTRACT
Abstract Aim: Low back pain (LBP) is disabling in older adults. Although physical activity interventions positively affect LBP, older adults are underrepresented in the literature. We aim to investigate the feasibility of conducting a study to evaluate a primary care program of exercise therapy and pain education, supported by mobile technology, for older adults with chronic LBP (compared to best practice advice). Methods: In this parallel, two-arm randomized pilot trial, we will recruit adults aged 60 years and older with chronic LBP. The experimental group (Physical Activity supported by low-cost mobile technology for Back pain-PAT-Back) will consist of an 8-week group exercise program based on pain education, exercises, graded activities, and in-home physical activity. Text messages will be sent to promote adherence to home exercises. The control group will receive an evidence-based educational booklet given during one individual consultation. Outcomes will include recruitment rate, adherence and retention rates, level of understanding of the intervention content, perception of the utility of mobile technology, compliance with the accelerometer in a sub-sample of patients, and adverse events. Discussion: The results of this study will form the basis for a large randomized controlled trial. This innovative approach to managing LBP in the primary care setting for older adults, if proven to be effective, can bring an important advance in the knowledge of chronic LBP management to this population.
