Education and Exercise for Patients With Longstanding Hip and Groin Pain (HIPSTER)

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Pain Chronic; Femoro Acetabular Impingement; Groin Injury
• Intervention / Treatment: Other: Usual care; Other: HIPSTER

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.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Ageberg, PhD; Phone Number: +46046-2224943; Email: eva.ageberg@med.lu.se

Study Locations

• Sweden
  • Malmo, Sweden
    • Recruiting
    • Skane University Hospital
    • Contact: Ioannis Kostogiannis, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Participants in this group will undergo usual care at the orthopedic department and will get a recommendation for physical therapist-led treatment in primary care.	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.
Experimental: HIPSTER; Participants 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This outcome will be collected at baseline and 1,2 and 5 years after baseline.
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?").	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	Treatment failure will be collected using a dichotomized question "Do you consider your current state so unsatisfactory that you think your treatment has failed?".	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	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).	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	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?".	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	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.	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	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.	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	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.	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	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.	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	Employment status will be measured using a Likert scale, from unemployed, student, part time work, full time work or retired.	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.
Surgical interventions	Any performed surgical interventions to the hip and/or groin region will be collected from medical records and self-reported questions.	This outcome will be collected from medical records at 1, 2 and 5 years.
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).	This outcome will be collected from the usual care group, after the primary end-point at 4 months.
Other non-operative treatment	Self-reported documentation of other non-operative treatments, like medications, injections etc.	This data will be collected at baseline, 4 months and 1 year.
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.	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).
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.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
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.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
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.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
Y-balance test	Single leg balance will be assessed using the Y-balance test. Distance (cm) and Limb symmetry index will be collected.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
Single leg balance	Single leg balance will be evaluated by postural sway using markers, 3D-motion capture and force plates.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
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.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
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.	This outcome will be collected at baseline and at the primary endpoint (4 months after baseline).
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.	This measure will be collected at baseline, and 5 year follow up.
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.	This data will be collected as part of standard procedure at the Department of Ortopedics, at baseline.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews - Physical therapists	Physical therapists trained in delivering the intervention in the experimental arm will be interviewed in a semi-standardised fashion, about their experiences of treating this patient population and their experience of delivering the experimental intervention.	The interviews will be conducted during active data collection, when clinicians have treated a minimum of 3 patients in the trial, with an estimated average of 6 months after data collection has started.
Qualitative interviews - Patients	A sub-group of participants (about 15 or until saturation) will be interviewed on-line in a semi-standardised fashion, about their perceptions of living with, and seeking care for, longstanding hip and groin pain. Participants randomized to the experimental arm (n=10), will also be asked to participate in interviews/workshops about their perception of the intervention.	The interviews will be conducted within 1 month of baseline data collection for the perceptions of living with, and seeking care for, longstanding hip and groin pain, and within 6 months of primary end point for the perception of the intervention.
Nested study - psychosocial variables	A subgroup (n=20 from each treatment arm) will answer additional questionnaires, as part of an exploratory nested study on the psychosocial response to patient education and treatment. 17 questions will cover 7 contructs (Support, Fear, Motivation, Self-efficacy, Expectations, Enablement & Acceptability), using Likert scales.	Data will be collected at baseline as well as at primary end-point (4 months).

Collaborators and Investigators

• Sponsor: Lund University
• Investigators: Principal Investigator: Eva Ageberg, PhD, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Longstanding hip and groin pain; Exercise therapy; Hip-related pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Pathological Conditions, Signs and Symptoms; Femoracetabular Impingement
• Other Study ID Numbers: 2022-05023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to Swedish laws and regulations, individual data points cannot be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No