Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia
ConditionHip Dysplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Aarhus
About this trial
This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle >10 degrees
Hip and/or groin pain as primary pain for at least three months
Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
Not candidate for PAO (negative impingement test, BMI >25, hip osteoarthritis, age >45 years or reduced hip range of motion)
Disqualifiers
Self-reported pain score >80 points measured with Copenhagen Hip and Groin outcome score
Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
BMI >35
Acetabular retroversion defined by crossover sign and posterior wall sign
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise and patient education
Other interventionOver a period of 6-months, patients will be offered eight one-to-one supervised training sessions. In these sessions, patients will be instructed in a home-based exercise programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty, allowing for individualised treatment with regard to exercise quality and perceived exertion according to the Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, a focus on exercise adherence and progression, and advice on physical activity.
Usual Care
Other interventionPatients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Exercise and patient educationExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
HAGOS pain sub-item measures degree of hip and/or groin pain through ten individual questions on a score from 0 to 100, higher score indicates lower pain.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)Secondary outcomes
1
Change in self-reported symptoms measured with HAGOS (continuous data)
HAGOS symptoms sub-item measures hip and/or groin symptoms and difficulties through seven individual questions on a score from 0 to 100, higher score indicates lower symptoms.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)2
Change in self-reported physical function, daily living (ADL) measured with HAGOS (continuous data)
HAGOS ADL sub-item measures degree of difficulty due to hip and/or groin problems through five individual questions on a score from 0 to 100, higher score indicates higher function.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)3
Change in self-reported physical function in sports and recreational activities (sport/recreation) measured with HAGOS (continuous data)
HAGOS sport/recreation sub-item measures degree of difficulty due to hip and/or groin problems through eight individual questions on a score from 0 to 100, higher score indicates higher function.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)4
Change in self-reported participation in physical activities (participation) measured with HAGOS (continuous data)
HAGOS participation sub-item measures how degree of ability to participate in physical activities is affected by hip and/or groin problems through two individual questions on a score from 0 to 100, higher score indicates higher ability to participate in physical activities.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)Other outcomes
1
Self-reported acceptable symptom state using the Patient Acceptable Symptom State (PASS) (dichotome data)
PASS measures perceived state of current hip and/or groin symptoms by the following question: Taking into account all the activities the patients are doing in their daily life, their level of pain, and also their functional impairments, do the patients consider that their current state of symptoms is acceptable (yes/no)?
Time frame
Measured at 6- and 12-month follow-up2
Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)
Hip and/or groin pain is measured on an electronic VAS from 0 to 100 mm within the last week.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up3
Change in self-reported hip and/or groin pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain during physical activity (continuous data)
Hip and/or groin pain is measured on an electronic VAS from 0 to 100 mm within the last week.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-up4
Change in self-reported back pain intensity measured with a 100 mm Visual Analogue Scale (VAS) for pain in rest (continuous data)
Back pain is measured on an electronic VAS from 0 to 100 mm within the last week.
Time frame
From baseline to 6-month follow-up. Outcome measured at baseline, 6- and 12-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Research Unit for General Practice, Aarhus University
Collaborator
VIA University College
Collaborator
Copenhagen University Hospital, Hvidovre
Collaborator
Defactum, Central Denmark Region
Collaborator
Source ClinicalTrials.gov