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Gluteal TendinitisNCT06418217

Exercise and Patient Education for Patients With Lateral Hip Pain

A study testing Exercise and Patient Education in people with Gluteal Tendinitis and Greater Trochanteric Pain Syndrome, run by Jeppe Lange at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Exercise and Patient Education
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
17 May 2024to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mathias Høgsholt, PT,PhD.-st. contact

+45 24205299

mathhg@rm.dk

Jeppe Lange, MD, PhD contact

jepplang@rm.dk

Denmark1 site, 1 recruiting
  • Horsens Regional Hospital

    Horsens, Horsens, 8700

    Mathias Høgsholt, PT,PhD.-st., +45 24205299, mathhg@rm.dk

    Jeppe Lange, MD,PhD., jepplang@rm.dk

    Recruiting

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Exercise and Patient Education
Keywords
Exercise, Patient education, Lateral Hip Pain, Rehabilitation
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise and Patient EducationProcedure or surgery

    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.

Study groups in NCT06418217
Study groupRoleWhat they receive
Physiotherapist-led exerciseExperimentalPhysiotherapy-led exercise of patients with lateral hip pain
Receives: Procedure: Exercise and Patient Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)

    The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

Secondary outcomes (15)
  1. Changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)

    The subscale "symptoms" on HAGOS measures the patients perception of hip and/or groin pain. It consist of seven items. A score from 0 to 100 is calculated, where a higher score is indicating lower symptoms.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  2. Changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)

    The subscale "ADL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  3. 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)

    The subscale "sport/recreation" on HAGOS measures the patients perception of hip and/or groin pain. It consist of eight items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  4. Changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)

    The subscale "PA" on HAGOS measures the patients perception of hip and/or groin pain. It consist of two items. A score from 0 to 100 is calculated, where a higher score is indicating higher ability to participate in physical activity.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  5. Changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)

    The subscale "QOL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher quality of life.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  6. Changes in the patient-reported outcome measure Oxford Hip Score (continuous data)

    Oxford Hip Score (OHS), which consists of 12items. OHS is developed and validated for patients undergoing total hip replacements to access pain and function. It is a composite score ranging from 0 (worst) to 48 (best).

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  7. Changes in the patient-reported outcome measure EQ-5D-5L (continuous data)

    European Questionnaire-5 Dimensions (EQ-5D-5L and EQ-VAS) consists of five items and a visual analogue score (VAS), a vertical line on which the patients score their perception of their overall health from 0 to 100 (worst to best)

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  8. Global Rating of Change (GRoC)

    GRoC consists of a 11-point scale, where the patient rates the perceived overall change of the hip condition from "very much better" to "very much worse" . Responses on GRoC will be considered successful if patients scored "moderately better" to "very much better". Global improvement will be measured as the percentage of successful reports.

    Measured: The outcome is conducted at 6-week and 3-months follow-up.

  9. Lateral hip pain on a numerical pain rating scale (NRS)

    Participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable). Participants will rate their average pain for the past 7 days during rest, at the beginning of activity, during activity, 2 hours after activity and the worst lateral hip pain.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  10. Changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)

    The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) is validated for patients with gluteal tendinopathy and measures the severity of disability related to the condition. VISA-G consist of eight items and appraise the pain in relation to gluteal tendinopathy by a score from 0-100, where a higher score will indicate lower pain and less disability.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  11. Changes of maximal isometric hip abduction muscle strength (continuous data)

    Maximal isometric hip abduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  12. Changes of maximal isometric hip adduction muscle strength (continuous data)

    Maximal isometric hip adduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  13. Changes of maximal isometric hip flexion muscle strength (continuous data)

    Maximal isometric hip flexion strength test measures the maximal voluntary isometric contraction in sitting position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  14. Changes of maximal isometric hip extension muscle strength (continuous data)

    Maximal isometric hip extension strength test measures the maximal voluntary isometric contraction in prone position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

  15. Changes of the number of repetitions of a 30 second sit to stand test (continuous data)

    Number of repetitions (sits to stand) performed during 30 seconds on a chair with a seat height of 45 cm.

    Measured: From baseline to 3 months follow-up. The outcome is also conducted at 6-week follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2024
  2. Study start17 May 2024
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06418217
Sponsor's protocol ID
1-16-02-180-24
Status last verified
Jun 2025
First submitted
13 May 2024
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data\_sharing\_june\_2017.pdf

Publications

  • Hogsholt M, Kierkegaard-Brochner S, Lange J, Lund B, Langgard Jorgensen S, Thorborg K, Bagger Bohn M. Physiotherapist-led education and exercise for patients with MRI-verified hip abductor tendon pathology: a prospective cohort study. BMJ Open. 2026 Sep 11;16(9):e120837. doi: 10.1136/bmjopen-2026-120837.

    PubMed 42727969
  • 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.

    PubMed 40940047

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Patient Education in people with Gluteal Tendinitis and Greater Trochanteric Pain Syndrome, run by Jeppe Lange at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mathias Høgsholt, PT,PhD.-st. (+45 24205299, mathhg@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06418217, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.

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