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Hip Pain ChronicHIPSTERNCT05853640

Education and Exercise for Patients With Longstanding Hip and Groin Pain

A study testing HIPSTER in people with Hip Pain Chronic and Femoro Acetabular Impingement, run by Lund University at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 years
What is being tested?
HIPSTER
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteSweden
Study dates
24 Jul 2023to Dec 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Ageberg, PhD contact

+46046-2224943

eva.ageberg@med.lu.se

Sweden1 site, 1 recruiting
  • Skane University Hospital

    Malmö

    Ioannis Kostogiannis, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: Patients With Longstanding HIP and Groin Pain Referred to Orthopedic Care: Effectiveness of Education and exerciSe ThERapy (HIPSTER)

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.

Read the 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.

Being tested
Usual care, HIPSTER
Keywords
Hip-related pain, Longstanding hip and groin pain, Exercise therapy, Rehabilitation
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual careOther

    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.

  • HIPSTEROther

    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.

Study groups in NCT05853640
Study groupRoleWhat they receive
Usual careActive comparatorParticipants in this group will undergo usual care at the orthopedic department and will get a recommendation for physical therapist-led treatment in primary care.
Receives: Other: Usual care
HIPSTERExperimentalParticipants in this group will undergo usual care at the orthopedic department and will also receive a semi-structured intervention according to the HIPSTER treatment model.
Receives: Other: HIPSTER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in iHOT-33 scores at 4 months

    iHOT-33 is a 33 question self-reported outcome scale, measuring hip-related quality of life. This outcome measure has been validated and translated to Swedish. The scores are summed on a 0 (worst)-100 (best) scale.

    Measured: The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).

Secondary outcomes (23)
  1. Change in iHOT-33 scores at 1, 2 and 5 years

    iHOT-33 is a 33 question self-reported outcome scale, measuring hip-related quality of life. This outcome measure has been validated and translated to Swedish. The scores are summed on a 0 (worst)-100 (best) scale.

    Measured: This outcome will be collected at baseline and 1,2 and 5 years after baseline.

  2. Patient acceptable symptom state (PASS)

    The patient acceptable symptom state (PASS) will be collected using a dichotomized question ("Taking into account your hip and groin function and pain, and how it affects your daily life, including your ability to participate in sport and social activities, do you consider that your current state is acceptable if it remained like that for the rest of your life?").

    Measured: 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.

  3. Treatment failure

    Treatment failure will be collected using a dichotomized question "Do you consider your current state so unsatisfactory that you think your treatment has failed?".

    Measured: 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.

  4. Perceived symptom improvement

    Perceived symptom improvement will be collected using a 7-point Global rating of change (GROC) scale, ranging from -3 (a lot worse), to +3 (a lot better).

    Measured: 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.

  5. Patient desire and beliefs regarding surgical intervention

    Patient desire and beliefs regarding surgical intervention will be collected using two dichotomized questions; "Do you want to undergo surgery?" and "Do you believe surgery is needed for you to get better?".

    Measured: 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.

  6. Physical activity

    Physical activity and return to sport/exercise will be collected using questions based on the Swedish National Board of Health and Welfare (Socialstyrelsen) physical activity screening, a self-reported measure of minutes spent doing strenuous and everyday activities.

    Measured: 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.

  7. Pain catastrophizing

    Pain catastrophizing will be measured with the Pain Catastrophizing Scale (PCS), a valid patient-reported outcome with 13 items. It is scored 0 to 52, with higher values indicating higher degrees of catastrophizing.

    Measured: 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.

  8. Pain self-efficacy

    Pain-related self-efficacy will be collected with the short-form Pain Self-efficacy Questionnaire (PSEQ-2), a commonly used measure of self-efficacy in musculoskeletal pain. PSEQ-2 consists of 2 questions. It is scored 0 to 12, with higher score indicating a greater degree of pain self-efficacy.

    Measured: 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.

  9. Health related quality of life

    Generic health-related quality of life will be measured using EQ5D. It is scored from 0 to 1, where 1 corresponds to perfect health, and is available in Swedish.

    Measured: 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.

  10. Employment status

    Employment status will be measured using a Likert scale, from unemployed, student, part time work, full time work or retired.

    Measured: 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.

  11. Other non-operative treatment

    Self-reported documentation of other non-operative treatments, like medications, injections etc.

    Measured: This data will be collected at baseline, 4 months and 1 year.

  12. Usual care content

    Any physical therapist-led intervention in the usual care group will be collected using self-reported questions regarding volume (number of sessions), content (overall focus of intervention) and adherence (patient compliance to prescribed intervention).

    Measured: This outcome will be collected from the usual care group, after the primary end-point at 4 months.

  13. Adherence

    Adherence will be collected by reporting of the number of supervised visits to a treating physical therapist as well as percentage of prescribed exercises completed, and any educational resources accessed.

    Measured: Adherence will be collected weekly from baseline until primary end-point (4 months) in the HIPSTER group. In the usual care group adherence will be collected at primary end-point (4 months).

  14. Hip range of motion

    Hip range of motion (in degrees) will be measured with a digital inclinometer in internal rotation in 90° of hip flexion and zero° flexion.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  15. Isometric hip muscle force production

    Isometric hip muscle force production will be measured (in Newton and nm/kg) with a belt-fixated handheld dynamometer for hip adduction, flexion and hip extension.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  16. Hop performance

    Hop performance will be assessed using the single leg hop for distance test. Distance (cm) and kinematics (joint angles) and forces (joint moments) will be measured.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  17. Y-balance test

    Single leg balance will be assessed using the Y-balance test. Distance (cm) and Limb symmetry index will be collected.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  18. Single leg balance

    Single leg balance will be evaluated by postural sway using markers, 3D-motion capture and force plates.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  19. Single leg squat

    Single leg squat performance will be evaluated using markers, 3D-motion capture and force plates to calculate kinematics (joint angles) and kinetics (joint moments) related to the task.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  20. Rear foot elevated split squat jump

    Lower body power will be evaluated using markers, 3D-motion capture and force plats to collect kinematics (joint angles) and kinetics (joint moments) during the task.

    Measured: This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).

  21. AP pelvic radiograph

    As part of standard procedure at the Department of Orthopedics at Skåne University hospital, an AP pelvic radiograph is used to measure the Lateral Centre Edge Angle and the Tönnis grade.

    Measured: This measure will be collected at baseline, and 5 year follow up.

  22. Alpha angle

    As part of standard procedure at the Department of Orthopedics at Skåne University Hospital, the modified Dunn projection will be used to calculate the alpha angle.

    Measured: This data will be collected as part of standard procedure at the Department of Ortopedics, at baseline.

  23. Surgical interventions

    Any performed surgical interventions to the hip and/or groin region will be collected from medical records and self-reported questions.

    Measured: This outcome will be collected from medical records at 1, 2 and 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start24 Jul 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 double blind randomized controlled trial, conforming to the CONSORT statement
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853640
Sponsor's protocol ID
2022-05023-01
Acronym
HIPSTER
Status last verified
Mar 2026
First submitted
22 Feb 2023
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to Swedish laws and regulations, individual data points cannot be shared.

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.

    PubMed 41942160

Questions about this trial

What is this clinical trial studying?

A study testing HIPSTER in people with Hip Pain Chronic and Femoro Acetabular Impingement, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Ageberg, PhD (+46046-2224943, eva.ageberg@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853640, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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