Clinical trial NCT06418217: Exercise and Patient Education for Patients With Lateral Hip Pain
Official title: 3 Months Semi-supervised Exercise Intervention for Patients With Hip Abductor Tendon Pathology (HATP): A Prospective Clinical Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gluteal Tendinitis
Greater Trochanteric Pain Syndrome
Hip and Thigh Injury
Rupture of Hip Abductor Tendon (Disorder)
Keywords: Exercise
Patient education
Lateral Hip Pain
Rehabilitation
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2024-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective cohort trial will investigate a progressive exercise protocol and patient education for patients with hip abductor tendon pathology. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), that will be conducted at baseline and at a 12 week follow-up.

Detailed description: This study protocol describes an interventional pragmatic prospective single-group cohort study, where the primary endpoint is change in hip pain measured with the revised HAGOS pain subscale following a 12 week intervention. Throughout the 12 weeks, eight physiotherapist-led exercise sessions will take place at Horsens Regional Hospital (HRH). Further, at the sessions at HRH patient education will be performed by the supervising physiotherapist. The first supervised sessions will be performed in continuation of the baseline assessment. The patients will be instructed to do the exercises daily at home in the time period between the physiotherapist-led sessions.

The primary aim is to investigate changes in patient-reported hip pain based on the subscale "pain" from the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from baseline to 12 week follow-up.

It is hypothesized that the revised HAGOS pain score will improve from baseline to 12 week follow-up.

Secondarily explorative subgroup analyses regarding whether patients with different MRI findings, pain profiles, age, sex and body mass index (BMI) respond differently to the intervention, will be performed.

All outcomes conducted will be published. That is, patient-reported outcomes, muscle strength, functional capacity and adherence to the exercise protocol.

A full study protocol will be published and made available.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* MRI verified HATP
* Lateral hip pain duration \> 6 months
* Ability to read and understand Danish.

Exclusion Criteria:

* Corticosteroid injection in the affected hip joint within the last six weeks prior to the intervention
* Previous bone-related surgery to the affected hip,
* Signs of bilateral HATP
* X-ray verified hip osteoarthritis
* Pregnancy

Primary outcomes:
measure: Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Secondary outcomes:
measure: Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in the patient-reported outcome measure Oxford Hip Score (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in the patient-reported outcome measure EQ-5D-5L (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Global Rating of Change (GRoC)
timeFrame: The outcome is conducted at 6-week and 3-months follow-up.
measure: Lateral hip pain on a numerical pain rating scale (NRS)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes of maximal isometric hip abduction muscle strength (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes of maximal isometric hip adduction muscle strength (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes of maximal isometric hip flexion muscle strength (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes of maximal isometric hip extension muscle strength (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
measure: Changes of the number of repetitions of a 30 second sit to stand test (continuous data)
timeFrame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.
Other outcomes:
measure: Adherence to the exercise program.
timeFrame: From baseline to 3 months follow-up.
Locations:
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
Study officials:
affiliation: Horsens Regional Hospital; Aarhus University
name: Mathias Høgsholt, PT, PhD.st.
role: PRINCIPAL_INVESTIGATOR
affiliation: Horsens Regional Hospital; Aarhus University
name: Jeppe Lange, MD, PhD
role: STUDY_DIRECTOR
affiliation: Regionshospitalet Horsens
name: Signe Kierkegaard-Brøchner, PhD
role: STUDY_CHAIR
affiliation: Copenhagen University Hospital, Hvidovre
name: Kristian Thorborg, PhD
role: STUDY_CHAIR
affiliation: Regionshospitalet Horsens
name: Marie Bagger Bohn, MD, PhD
role: STUDY_CHAIR
References: