Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care – study protocol for a randomized clinical trialReport as inadecuate




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Trials

, 15:102

First Online: 02 April 2014Received: 05 June 2013Accepted: 21 March 2014DOI: 10.1186-1745-6215-15-102

Cite this article as: Eklund, A., Axén, I., Kongsted, A. et al. Trials 2014 15: 102. doi:10.1186-1745-6215-15-102

Abstract

BackgroundLow back pain LBP is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes secondary prevention, seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration tertiary prevention, is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies.

Methods-DesignThis study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care chiropractic maintenance care in a population of patients with recurrent or persistent LBP.

Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health EQ-5D, function the Roland Morris Disability Questionnaire, psychological profile the Multidimensional Pain Inventory, pain intensity the Numeric Rating Scale, and work absence.

The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.

Subjects are randomly allocated into two treatment arms: 1 Symptom-guided treatment patient controlled, receiving care when patients feel a need. 2 Preventive treatment clinician controlled, receiving care on a regular basis. Eligibility screening takes place in two phases: first, when assessing the primary inclusion-exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages.

DiscussionThis study investigates a manual strategy chiropractic maintenance care for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach. Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results.

Trial registrationClinical trials.gov; NCT01539863, February 22, 2012. The first patient was randomized into the study on April 13th 2012.

KeywordsChiropractic Low back pain Maintenance care Manual therapy Prevention Randomized controlled trial Secondary prevention Spinal manipulation Tertiary prevention AbbreviationsEQ-5DEuroQol 5 Dimensions

LBPNon-specific low back pain

MCMaintenance care

MPI-SMultidimensional pain inventory

NRS-11Numerical rating scale 11 steps, 0–10

RMDQRoland Morris Disability Questionnaire

WPAI-GHWork productivity and activity impairment questionnaire – general health.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-102 contains supplementary material, which is available to authorized users.

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Author: Andreas Eklund - Iben Axén - Alice Kongsted - Malin Lohela-Karlsson - Charlotte Leboeuf-Yde - Irene Jensen

Source: https://link.springer.com/







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