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

Primary Purpose

Hip Pain Chronic, Femoro Acetabular Impingement, Groin Injury

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Usual care
HIPSTER
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Pain Chronic focused on measuring Hip-related pain, Longstanding hip and groin pain, Exercise therapy, Rehabilitation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Skane University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

HIPSTER

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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?").
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?".
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).
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?".
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.
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.
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.
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.
Employment status
Employment status will be measured using a Likert scale, from unemployed, student, part time work, full time work or retired.
Surgical interventions
Any performed surgical interventions to the hip and/or groin region will be collected from medical records and self-reported questions.
Osteoarthritis development
The presence of narrowing joint space will be measured using Tönnis grade, measured on an AP radiograph.
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).
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.
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.
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.
Y-balance test
Single leg balance will be assessed using the Y-balance test. Distance (cm) and Limb symmetry index will be collected.
Single leg balance
Single leg balance will be evaluated by postural sway using markers, 3D-motion capture and force plates.
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.
Step down
Step down 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.
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.

Full Information

First Posted
February 22, 2023
Last Updated
August 24, 2023
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT05853640
Brief Title
Education and Exercise for Patients With Longstanding Hip and Groin Pain
Acronym
HIPSTER
Official Title
Patients With Longstanding HIP and Groin Pain Referred to Orthopedic Care: Effectiveness of Education and exerciSe ThERapy (HIPSTER)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
December 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Pain Chronic, Femoro Acetabular Impingement, Groin Injury
Keywords
Hip-related pain, Longstanding hip and groin pain, Exercise therapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 double blind randomized controlled trial, conforming to the CONSORT statement
Masking
ParticipantOutcomes Assessor
Masking Description
The outcome assessors, and participants will be blinded to group allocation. An independent statistician, blinded to treatment allocation, will perform the statistical analysis. Treatment providers will be blinded to study hypothesis and the content of the different treatment arms.
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIPSTER
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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
Intervention Name(s)
HIPSTER
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in iHOT-33 scores at 4 months
Description
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.
Time Frame
The primary outcome will be collected at baseline and at the primary end-point (4 months after baseline).
Secondary Outcome Measure Information:
Title
Change in iHOT-33 scores at 1, 2 and 5 years
Description
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.
Time Frame
This outcome will be collected at baseline and 1,2 and 5 years after baseline.
Title
Patient acceptable symptom state (PASS)
Description
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?").
Time Frame
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.
Title
Treatment failure
Description
Treatment failure will be collected using a dichotomized question "Do you consider your current state so unsatisfactory that you think your treatment has failed?".
Time Frame
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.
Title
Perceived symptom improvement
Description
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).
Time Frame
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.
Title
Patient desire and beliefs regarding surgical intervention
Description
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?".
Time Frame
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.
Title
Physical activity
Description
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.
Time Frame
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.
Title
Pain catastrophizing
Description
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.
Time Frame
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.
Title
Pain self-efficacy
Description
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.
Time Frame
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.
Title
Health related quality of life
Description
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.
Time Frame
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.
Title
Employment status
Description
Employment status will be measured using a Likert scale, from unemployed, student, part time work, full time work or retired.
Time Frame
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.
Title
Surgical interventions
Description
Any performed surgical interventions to the hip and/or groin region will be collected from medical records and self-reported questions.
Time Frame
This outcome will be collected from medical records at 1, 2 and 5 years.
Title
Osteoarthritis development
Description
The presence of narrowing joint space will be measured using Tönnis grade, measured on an AP radiograph.
Time Frame
This measure will be collected at baseline, and at 2 and 5 year follow ups.
Title
Usual care content
Description
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).
Time Frame
This outcome will be collected from the usual care group, after the primary end-point at 4 months.
Title
Hip range of motion
Description
Hip range of motion (in degrees) will be measured with a digital inclinometer in internal rotation in 90° of hip flexion and zero° flexion.
Time Frame
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.
Title
Isometric hip muscle force production
Description
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.
Time Frame
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.
Title
Hop performance
Description
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.
Time Frame
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.
Title
Y-balance test
Description
Single leg balance will be assessed using the Y-balance test. Distance (cm) and Limb symmetry index will be collected.
Time Frame
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.
Title
Single leg balance
Description
Single leg balance will be evaluated by postural sway using markers, 3D-motion capture and force plates.
Time Frame
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.
Title
Single leg squat
Description
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.
Time Frame
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.
Title
Step down
Description
Step down 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.
Time Frame
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.
Title
Rear foot elevated split squat jump
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Qualitative interviews - Patients
Description
A sub-group of participants (about 10 or until saturation) will be interviewed in a semi-standardised fashion, about their experiences of undergoing the intervention.
Time Frame
The interviews will be conducted between 4 months and 6 months after baseline.
Title
Qualitative interviews - Physical therapists
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Ageberg, PhD
Phone
+46046-2224943
Email
eva.ageberg@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skane University Hospital
City
Malmö
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Kostogiannis, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to Swedish laws and regulations, individual data points cannot be shared.

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Education and Exercise for Patients With Longstanding Hip and Groin Pain

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