Clinical trial NCT05853640: Education and Exercise for Patients With Longstanding Hip and Groin Pain
Official title: Patients With Longstanding HIP and Groin Pain Referred to Orthopedic Care: Effectiveness of Education and exerciSe ThERapy (HIPSTER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Pain Chronic
Femoro Acetabular Impingement
Groin Injury
Keywords: Hip-related pain
Longstanding hip and groin pain
Exercise therapy
Rehabilitation
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 double blind randomized controlled trial, conforming to the CONSORT statement
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in iHOT-33 scores at 4 months
timeFrame: The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).
Secondary outcomes:
measure: Change in iHOT-33 scores at 1, 2 and 5 years
timeFrame: This outcome will be collected at baseline and 1,2 and 5 years after baseline.
measure: Patient acceptable symptom state (PASS)
timeFrame: 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.
measure: Treatment failure
timeFrame: 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.
measure: Perceived symptom improvement
timeFrame: 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.
measure: Patient desire and beliefs regarding surgical intervention
timeFrame: 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.
measure: Physical activity
timeFrame: 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.
measure: Pain catastrophizing
timeFrame: 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.
measure: Pain self-efficacy
timeFrame: 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.
measure: Health related quality of life
timeFrame: 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.
measure: Employment status
timeFrame: 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.
measure: Surgical interventions
timeFrame: This outcome will be collected from medical records at 1, 2 and 5 years.
measure: Osteoarthritis development
timeFrame: This measure will be collected at baseline, and at 2 and 5 year follow ups.
measure: Usual care content
timeFrame: This outcome will be collected from the usual care group, after the primary end-point at 4 months.
measure: Hip range of motion
timeFrame: 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.
measure: Isometric hip muscle force production
timeFrame: 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.
measure: Hop performance
timeFrame: 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.
measure: Y-balance test
timeFrame: 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.
measure: Single leg balance
timeFrame: 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.
measure: Single leg squat
timeFrame: 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.
measure: Step down
timeFrame: 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.
measure: Rear foot elevated split squat jump
timeFrame: 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 outcomes:
measure: Qualitative interviews - Patients
timeFrame: The interviews will be conducted between 4 months and 6 months after baseline.
measure: Qualitative interviews - Physical therapists
timeFrame: 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.
Locations:
city: Malmö
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Lund University
name: Eva Ageberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: