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Recruiting NCT06418217

Exercise and Patient Education for Patients With Lateral Hip Pain

No phase Interventional Gluteal Tendinitis Greater Trochanteric Pain Syndrome Hip and Thigh Injury Rupture of Hip Abductor Tendon (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise and Patient Education.
Who it may be relevant to
Registry conditions: Gluteal Tendinitis, Greater Trochanteric Pain Syndrome, Hip and Thigh Injury, Rupture of Hip Abductor Tendon (Disorder). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

3 Months Semi-supervised Exercise Intervention for Patients With Hip Abductor Tendon Pathology (HATP): A Prospective Clinical Cohort Study

Overview

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.

Interventions

  • Procedure Exercise and Patient Education
    Patients will undergo a 12-week physiotherapist-led exercise program consisting of 8 supervised sessions and home-based training in between. Patients will keep training diaries, where each session is tracked in regards of completed repetitions and pain before and after the sessions. Each session will consist of four exercises.

Primary outcome measures

  • Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
Secondary outcome measures (12)
  • Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • 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) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes in the patient-reported outcome measure Oxford Hip Score (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes in the patient-reported outcome measure EQ-5D-5L (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Global Rating of Change (GRoC) [Time frame: The outcome is conducted at 6-week and 3-months follow-up.]
  • Lateral hip pain on a numerical pain rating scale (NRS) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes of maximal isometric hip abduction muscle strength (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]
  • Changes of maximal isometric hip adduction muscle strength (continuous data) [Time frame: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Horsens Regional Hospital — Horsens

Publications

  • Hogsholt M, Kierkegaard-Brochner S, Lange J, Thorborg K, Bohn MB. Physiotherapist-led education and exercise for patients with MRI-verified hip abductor tendon pathology: a protocol for a prospective cohort study. BMJ Open. 2025 Sep 11;15(9):e106517. doi: 10.1136/bmjopen-2025-106517. PMID 40940047

Identifiers

NCT: NCT06418217 · 1-16-02-180-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗