Implementation of Evidence-based Guidelines for Assessment and Counseling of Patients With Neck and Back Pain in Health Care Centers (ALIGN)
The overall aim is to investigate the health outcomes and consequences, from an individual and a societal perspective, of adding licensed Manual Therapists as first-contact healthcare providers in Primary Health Care centers to triage (not treat) patients seeking care for Neck and Back Pain.
A hybrid, quasi-experimental Target Trial Emulation design employing mixed methods contextualized to participating Primary Health Care centers will be used.
Neck and Back Pain patients with a physician's appointment at a participating Primary Health Care center will be included and followed one year;
- 300 patients with care as usual who see their physician (control group),
- 300 patients who see a licensed naprapath/chiropractor for an initial evidence-based assessment/screening before the physicians' visit.
Patient outcomes include recovery, function and work ability, as well as health economy are compared between the groups.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Many visits to primary healthcare centers (PHCs) concern neck and/or back pain (NBP). Evidence-based clinical guidelines are often not considered, and low-value care, including unnecessary imaging, prescription of medications, injections, unnecessary surgery, and sick leave, is instead used, leading to poor patient outcomes and high societal costs. The primary healthcare system is severely pressured, and there is a need to reduce the burden of this common patient group on the physicians. Licensed naprapaths and chiropractors (manual therapist (MT)) have been part of Swedish healthcare for >30 years, but their competence is seldom utilized at PHCs. MT as first-contact providers within PHCs may reduce the burden of NBP in the population by improving adherence to evidence-based guidelines, reducing the workload on physicians, minimizing unnecessary healthcare procedures, and reducing expenditure.
Patient reported outcomes include pain, function, work ability and satisfaction, and health economy are based on sickness absence, care consumption, referrals and pharmaceutical use will be compared between groups.
Our hypothesis is that the intervention will lead to symptom improvement and work ability, as well as decrease the risk of sickness absence and low value care (sickness absence, care consumption, referrals and pharmaceutical use) for these patients. Thus, we hypothesize positive consequences for the individual and for society.
Advanced epidemiological/statistical methods address confounding when comparing the groups. Physicians' and patients' experiences, facilitators, and barriers to the implementation of the intervention will also be studied.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Iben Axén, PhD
- Номер телефона: +46 70 44 00 618
- Электронная почта: iben.axen@ki.se
Места учебы
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Stockholm, Швеция
- Karolinska Institutet , Stockholm 171 77 Solna
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Контакт:
- Iben Axén, PhD
- Номер телефона: +46 70 44 00 618
- Электронная почта: iben.axen@ki.se
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Patients 18-70 years, with an appointment with a physician at the primary health care center for a new episode of pain or discomfort in the neck, mid-back or lower back with or without radiating symptoms to the head, arms, or leg
Exclusion Criteria:
- Sick-leave for neck- and backpain the preceding three months (at least 50%), having consulted or been treated by licensed healthcare provider for neck- and backpain during the preceding three months, and not mastering the Swedish language
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Н/Д
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: MT management
The intervention in the index group is a triage performed by the licensed manual therapist, MT: take the anamnesis, perform a clinical assessment and examination (including assessment of fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to evidence-based clinical guidelines, i.e., high-value care.
In summary, these guidelines state that patients with no "Red flags" (signs of pathology) or "Yellow flags" (psychological risk factors such as unrealistic beliefs about their pain, catastrophizing, kinesiophobia) shall self-manage when they are adequately informed about their condition and that they need to continue with their usual activities, such as work, physical activity, and social life.
The role of the MT is to triage patients according to the best evidence into three groups: those with little or no risk of persistent pain, those with a moderate risk, and those with a substantial risk of a bad prognosis.
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The intervention in the index group is a triage performed by the licensed manual teerapeut: take the anamnesis, perform a clinical and assessment formula examination (fear/avoidance, pain catastrophizing, and expectations), provide a diagnosis, and give the patient recommendations according to current evidence-based clinical guidelines.
The outcome in this intervention arm will be compared to study participants with "care as usal" included in sthe study earlier.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient-perceived Global Perceived Effect
Временное ограничение: 12 months
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This outcome is measured through a Lickert scale.
The single question is: "compared with the start of the trial, how is your [condition] today?"
Answers from "completely recovered" to "much worse"
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12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Chronic pain
Временное ограничение: 12 months
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12 months
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Activity limitations
Временное ограничение: 12 months
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Roland Morris disability questionnaire, Nordic pain questionnaire.
These are validated instruments assessing the influence of the condition on everyday activities.
Example "my [condition] prevents me from doing household chores" -agree/do not agree.
The instrument then results in a score where high scores mean that the condition highly affects daily activities.
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12 months
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Health-related quality of life
Временное ограничение: 12 months
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EuorQol-5 dimensions is a validated questionnaire that results in a score between 0 and 1(perfect health).
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12 months
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Societal costs
Временное ограничение: 12 months
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Cost related to care consumption, sick-leave, referrals and pharmaceuticals.
Self-reported every three months, participants are reporting all care relating to their condition, number of care visits and cost of visits.
Travel time is attributed to each care visit.
This will also include visits to specialists.
They are reporting the number of days they have been off work due to the condition, and all type of medication consumed for their condition.
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12 months
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Work Ability
Временное ограничение: 12 months
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Measures the balance between a person's individual resources (such as health, skills, and mental energy) and the actual demands of their job
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12 months
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sickness absence
Временное ограничение: 12 months
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The number of days an individual has been off work because of neck and back pain
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12 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Quality of the assessment by manual therapists
Временное ограничение: 12 months
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A qualitative outcome collected in interviews with healthcare personell and patients
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12 months
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Соавторы и исследователи
Спонсор
Соавторы
Публикации и полезные ссылки
Общие публикации
- Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, Turner JA, Maher CG; Lancet Low Back Pain Series Working Group. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018 Jun 9;391(10137):2368-2383. doi: 10.1016/S0140-6736(18)30489-6. Epub 2018 Mar 21.
- Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.
- GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
- Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.
- Bornhoft L, Thorn J, Svensson M, Nordeman L, Eggertsen R, Larsson MEH. More cost-effective management of patients with musculoskeletal disorders in primary care after direct triaging to physiotherapists for initial assessment compared to initial general practitioner assessment. BMC Musculoskelet Disord. 2019 May 1;20(1):186. doi: 10.1186/s12891-019-2553-9.
- Slade SC, Kent P, Patel S, Bucknall T, Buchbinder R. Barriers to Primary Care Clinician Adherence to Clinical Guidelines for the Management of Low Back Pain: A Systematic Review and Metasynthesis of Qualitative Studies. Clin J Pain. 2016 Sep;32(9):800-16. doi: 10.1097/AJP.0000000000000324.
- Egerton T, Diamond LE, Buchbinder R, Bennell KL, Slade SC. A systematic review and evidence synthesis of qualitative studies to identify primary care clinicians' barriers and enablers to the management of osteoarthritis. Osteoarthritis Cartilage. 2017 May;25(5):625-638. doi: 10.1016/j.joca.2016.12.002. Epub 2016 Dec 7.
- Wiitavaara B, Fahlstrom M, Djupsjobacka M. Prevalence, diagnostics and management of musculoskeletal disorders in primary health care in Sweden - an investigation of 2000 randomly selected patient records. J Eval Clin Pract. 2017 Apr;23(2):325-332. doi: 10.1111/jep.12614. Epub 2016 Aug 19.
- Hallberg S, Rolfson O, Karppinen J, Schiottz-Christensen B, Stubhaug A, Rivano Fischer M, Gerdle B, Toresson Grip E, Gustavsson A, Robinson RL, Varenhorst C, Schepman P. Burden of disease and management of osteoarthritis and chronic low back pain: healthcare utilization and sick leave in Sweden, Norway, Finland and Denmark (BISCUITS): study design and patient characteristics of a real world data study. Scand J Pain. 2022 Jul 20;23(1):126-138. doi: 10.1515/sjpain-2021-0212. Print 2023 Jan 27.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KIIMMIIB
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .