Education and Exercise for Patients With Longstanding Hip and Groin Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual care, HIPSTER.
- Who it may be relevant to
- Registry conditions: Hip Pain Chronic, Femoro Acetabular Impingement, Groin Injury. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patients With Longstanding HIP and Groin Pain Referred to Orthopedic Care: Effectiveness of Education and exerciSe ThERapy (HIPSTER)
Overview
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.
Detailed description
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.
Interventions
- Other 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. - Other 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
Primary outcome measures
- Change in iHOT-33 scores at 4 months [Time frame: The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).]
Secondary outcome measures (12)
- Change in iHOT-33 scores at 1, 2 and 5 years [Time frame: This outcome will be collected at baseline and 1,2 and 5 years after baseline.]
- Patient acceptable symptom state (PASS) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: This data will be collected at baseline, 4 months and 1 year.]
- Usual care content [Time frame: This outcome will be collected from the usual care group, after the primary end-point at 4 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Skane University Hospital — Malmö
Publications
- 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
Identifiers
NCT: NCT05853640 · 2022-05023-01