Education and Exercise for Patients With Longstanding Hip and Groin Pain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Usual care, HIPSTER.
- Кому может быть актуально
- Состояния в реестре: Hip Pain Chronic, Femoro Acetabular Impingement, Groin Injury. Базовые параметры: 18 лет — 55 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Patients With Longstanding HIP and Groin Pain Referred to Orthopedic Care: Effectiveness of Education and exerciSe ThERapy (HIPSTER)
Обзор
Longstanding hip and groin pain (LHGP) is a common and debilitating problem in young to middle aged individuals. These patients often get referred to orthopedic departments. Consensus statements on the management of these patients commonly recommend a physical therapist-led intervention as the first line intervention. However, the optimal content and delivery of this intervention is currently unknown. In this study we will compare the effectiveness of usual care (unstructured physical therapist-led intervention) to a semi-structured, progressive individualized physical therapist-led intervention on hip-related quality of life in people with longstanding hip and groin pain referred to an orthopedic department.
Подробное описание
This study is a parallel-group randomized controlled trial, comparing the effectiveness of patient education and exercise therapy to usual care on hip-related quality of life in people with longstanding hip and groin pain referred to an orthopedic department. Participants will be allocated in a 1:1 ratio to either usual care (orthopedic diagnostic pathway and recommendation of physical therapy) or the HIPSTER model, a semi-structured, progressive and individualized physical therapist-led intervention focusing on patient education and exercise therapy.
The primary aim of this trial is to determine the effectiveness of a structured physical therapist-led treatment model (HIPSTER) compared to usual care on hip-related quality of life. The primary hypothesis is that the HIPSTER model will be superior to usual care by at least 10 points between group change in improving self-reported hip-related function and quality of life, measured by iHOT-33.
Secondary aims include comparing group differences in achievement of patient acceptable symptom state (PASS) at 4 months and to compare between group changes in self-reported physical activity, pain self-efficacy, and pain catastrophizing, and physical performance tests regarding ROM, muscle force production, hop performance and balance between the HIPSTER group and usual care (baseline to 4 months), as well as cost-effectiveness of the interventions.
A full trial protocol will be published. The primary analysis will be performed using a t-test, according to intention-to-treat principles. A per protocol analysis will also be conducted, comparing participants who completed usual care or the HIPSTER model with high fidelity. Relevant parametric and non-parametric tests will be performed to compare change in physical performance tests and secondary PROMs.
A subgroup of patients will be included in qualitative study, using a semi-structured interview to capture the experience of participating in the HIPSTER intervention. A subgroup of patients will also answer additional questions regarding psychosocial factors related to hip and groin pain.
Вмешательства
- Другое Usual care
Usual care at the orthopedic department consists of a clinical examination, radiological imaging, and a diagnostic injection. A recommendation to get physical therapy treatment in primary care will be provided, but this intervention will not be controlled by the investigators in any capacity. - Другое HIPSTER
Patients will be provided with usual care at the orthopedic department, which consists of a clinical examination, radiological imaging, and a diagnostic injection. In addition, participants in this group will be referred to physical therapists trained in administering a semi-structured, individualized, progressive treatment. This 16-week intervention targets known physical and psychological impairments in people with long-standing hip and groin pain, using exercise therapy and patient education
Первичные конечные точки
- Change in iHOT-33 scores at 4 months [Срок оценки: The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).]
Вторичные конечные точки (12)
- Change in iHOT-33 scores at 1, 2 and 5 years [Срок оценки: This outcome will be collected at baseline and 1,2 and 5 years after baseline.]
- Patient acceptable symptom state (PASS) [Срок оценки: This outcome will be collected at the primary endpoint (4 months after baseline). In addition it will also be collected at 1,2 and 5 years after baseline.]
- Treatment failure [Срок оценки: This outcome will be collected at the primary endpoint (4 months after baseline). In addition it will also be collected at 1,2 and 5 years after baseline.]
- Perceived symptom improvement [Срок оценки: This outcome will be collected at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Patient desire and beliefs regarding surgical intervention [Срок оценки: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Physical activity [Срок оценки: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Pain catastrophizing [Срок оценки: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Pain self-efficacy [Срок оценки: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Health related quality of life [Срок оценки: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Employment status [Срок оценки: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline). In addition it will also be collected at 1 year after baseline.]
- Other non-operative treatment [Срок оценки: This data will be collected at baseline, 4 months and 1 year.]
- Usual care content [Срок оценки: This outcome will be collected from the usual care group, after the primary end-point at 4 months.]
Критерии участия
Критерии включения
- Men and women aged 18-55 years
- Referred to the Dept of Orthopedics due to hip and/or groin pain
- Activity-related unilateral or bilateral groin pain >3 months
- Pain reproduced with the FADIR test.
Критерии исключения
- Groin pain originating from any diagnosis with other treatment pathways, i.e., i) Acute traumatic hip injuries (such as hip dislocation, hip fractures); ii) Verified moderate or severe OA (Tönnis grade >1); iii) Palpable hernia; iv) Low-back pain with a positive straight leg raise test and/or hip and groin pain provoked primarily by repeated motions of the lumbar spine; v) Sacroiliac joint pain with thigh thrust test.
- Co-morbidities potentially interfering with treatment, i.e., i) Co-morbidities overriding the hip and groin-related symptoms and dysfunction (such as other acute lower limb injuries, rheumatoid arthritis etc), ii) Co-morbidities prohibiting physical activity and training (heart disease etc), iii) Current psycho-social disorders requiring treatment.
- Other: i) History of drug abuse within the last year; ii) Not understanding the language of interest (Scandinavian languages, or English).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Швеция · 1 центр
- Skane University Hospital — Malmö
Публикации
- Estberger A, Kemp J, Thorborg K, Kostogiannis I, Palsson A, Ageberg E. Effectiveness of a structured physical therapist-led intervention compared to usual care in people with longstanding hip and groin pain referred to orthopaedic care in Sweden: protocol for a randomised controlled trial (the HIPSTER trial). BMJ Open. 2026 Apr 6;16(4):e113795. doi: 10.1136/bmjopen-2025-113795. PMID 41942160
Идентификаторы
NCT: NCT05853640 · 2022-05023-01