Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853640
Status:
RECRUITING
Last Update Posted:
2023-08-25
First Post:
2023-02-22
Brief Title:
Education and Exercise for Patients With Longstanding Hip and Groin Pain
Sponsor:
Lund University
Organization:
Lund University
Study Overview
Official Title:
Patients With Longstanding HIP and Groin Pain Referred to Orthopedic Care Effectiveness of Education and exerciSe ThERapy HIPSTER
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIPSTER
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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None