Education and Exercise for Patients With Longstanding Hip and Groin Pain

NCT ID: NCT05853640

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2030-12-01

Brief 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. 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. Another subgroup will perform more advanced biomechanical analysis, including 3d-motion analysis.

Conditions

Hip Pain Chronic; Femoro Acetabular Impingement; Groin Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

HIPSTER

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Ageberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Skane University Hospital

Malmo, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Eva Ageberg, PhD

Role: CONTACT

eva.ageberg@med.lu.se

+46046-2224943

Facility Contacts

Ioannis Kostogiannis, PhD

Role: primary

Other Identifiers

2022-05023-01

Identifier Type: -

Identifier Source: org_study_id