Greater Trochanteric Pain SyndromeNCT07848971
Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Practice
A study testing Patient advice, Patient advice plus exercise and Patient advice plus exercise plus corticosteroid injection in people with Greater Trochanteric Pain Syndrome and Gluteal Tendinopathy, run by Malene Kjær Bruun at 2 sites in Denmark.
Trial summary
Pain on the outside of the hip, known as greater trochanteric pain syndrome (GTPS), is a common problem. It is caused by irritation of the tendons that attach the buttock muscles to the hip bone. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Greater Trochanteric Pain Syndrome, Gluteal Tendinopathy, Lateral Hip Pain
- What is being tested?
- Patient advice, Patient advice plus exercise and Patient advice plus exercise plus corticosteroid injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2026to Sep 2028
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35+ years of age .
- Self-reported lateral hip pain for at least 12 weeks, with an average intensity (when pain is present) of at least 4/10 over the past week on a Numeric Rating Scale (NRS, 0-10; 0 = no hip pain, 10 = worst imaginable hip pain).
- Access to a computer, smartphone, or tablet with an internet connection.
- Tenderness on palpation of the greater trochanter AND at least one of the following:
- Reproduction of lateral hip pain with a 30-sec single-leg stance test.
- Reproduction of lateral hip pain with the test Flexion, Adduction and External Rotation with Resistance (FADER-R).
- Ability to speak and understand Danish (written and oral).
Who cannot join
- Corticosteroid injection in the affected hip within the last 6 months.
- History of systemic inflammatory diseases, e.g., rheumatoid arthritis, spondylarthritis.
- Weekly intake of oral glucocorticoids.
- Individuals with diabetes characterised by unstable or inadequately controlled blood glucose levels (e.g., due to recent medication adjustments or unstable pharmacological management) will be excluded.
- Received any treatment by a healthcare professional for GTPS within the previous 12 weeks or made any substantial changes to usual self-management of the condition in the last 4 weeks (eg, started performing stretching, made a substantial decrease in physical activity level).
- History of prior hip or lumbar back surgery.
Show all 10Show fewer
- Current low back pain (>5 NRS) or episodes of low back pain within the last 3 months that have caused sick leave and/or treatment by a health professional.
- Physical or mental disabilities that make it impossible to understand and perform exercises and complete questionnaires.
- Current or planned pregnancy or breastfeeding.
- Rupture of gluteal tendon identified on ultrasound.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Forskningsenheden for Almen Praksis i Aalborg
Gistrup, 9260
Malene Kjær Bruun, 24415780, mkbruun@dcm.aau.dk
Institut for idrætsmedicin, Bispebjerg og Frederiksberg Hospital
København NV, 2400
Finn E Johannsen, 31671057, f.e.johannsen@dadlnet.dk
About this study
Official title: Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Prac-tice: A Randomised Clinical Trial
Pain on the outside of the hip, known as greater trochanteric pain syndrome (GTPS), is a common problem. It is caused by irritation of the tendons that attach the buttock muscles to the hip bone. The condition most often affects middle-aged women and makes everyday activities such as walking, climbing stairs, sitting and lying on the painful side difficult. Many people continue to have pain for years. Today, there is no agreed treatment approach for GTPS in general practice, and it is unclear which of the treatments commonly used works best.
This study compares three treatments that are all already used in Danish healthcare. Participants are adults aged 35 or older who have had pain on the outside of the hip for at least 12 weeks and who show typical signs of GTPS on a clinical examination. An ultrasound scan of the hip is performed to rule out a torn tendon. In total, 192 participants will be recruited, mainly through general practice, and also through specialist clinics, a hospital sports medicine department and social media.
Read more
Participants are assigned by chance (randomised) to one of three groups:
- Advice: a leaflet explaining the condition and how to manage daily activities, with a brief verbal explanation.
- Advice plus home exercises: the leaflet plus three simple strength exercises done at home three times a week, with written instructions, online videos and an exercise diary.
- Advice plus home exercises plus a steroid injection: the same as group 2, plus a cortisone injection given with ultrasound guidance into the painful area of the hip within a week of the first visit. The injection can be repeated once after 6 weeks if pain persists.
The main question is how many participants in each group feel much better after 3 months. Participants also answer questions about pain, hip function, quality of life, physical activity, exercise adherence, side effects and use of healthcare. Questionnaires are completed online after 1, 2, 3, 6 and 12 months, and participants attend three visits with a clinical examination and ultrasound scan: at the start, after 6 weeks and after 3 months.
The study takes place at two sites in Denmark: Bispebjerg Hospital in Copenhagen and the Research Unit for General Practice in Aalborg. We expect that adding exercises, and adding exercises and an injection, will lead to greater improvement than advice alone. The results will help guide treatment of GTPS in general practice.
- Being tested
- Patient advice, Patient advice plus exercise, Patient advice plus exercise plus corticosteroid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient adviceBehavioural
Participants receive a patient information leaflet describing the GTPS condition and emphasising self-management, particularly load management. The leaflet is based on material from a recent randomised trial (the LEAP trial), translated into Danish and adapted to a Danish context through input from clinicians and patients with GTPS. At baseline, the leaflet is handed out together with a brief verbal summary of the key points. A follow-up phone call is made approximately one week after baseline to address any questions regarding the assigned intervention
Patient advice plus exerciseBehavioural
Participants receive a home-based strength exercise programme in addition to the patient information leaflet. The programme consists of three body-weight exercises (hip bridge, hip abduction and squat) to be performed three times per week. At baseline, participants receive a brief standardised verbal introduction of approximately 10 minutes covering key exercises, technique and progression principles. Written instructions with pictures, access to online instruction videos and a training diary are also provided. Participants are instructed to continue exercising until they reach a personally acceptable symptom level, and for an additional four weeks thereafter. Exercise adherence is monitored using the training diary. A follow-up phone call is made approximately one week after baseline to address any questions regarding the exercise programme.
Patient advice plus exercise plus corticosteroid injectionOther
Participants receive an ultrasound-guided corticosteroid injection (1 ml triamcinolone 40 mg/ml and 1 ml lidocaine 10 mg/ml) at the insertion of the gluteal tendons on the greater trochanter of the affected hip, administered by a specialist in rheumatology no later than 7 days after the baseline visit. If pain persists at the 6-week follow-up (NRS >4), a repeat injection may be offered. Participants are instructed to begin the exercise programme the day after the injection or as soon as any post-injection pain flare has resolved.
| Study group | Role | What they receive |
|---|---|---|
| Patient advice | Active comparator | Patient information leaflet on GTPS and load management, handed out at baseline with brief oral information. Receives: Behavioral: Patient advice |
| Patient advice + exercise | Experimental | Patient information leaflet plus a home exercise programme (hip bridge, hip abduction, squat) performed three times a week, with written instructions, online videos and a training diary. Receives: Behavioral: Patient advice; Behavioral: Patient advice plus exercise |
| Patient advice + exercise + corticosteroid injection | Experimental | Patient information leaflet and home exercise programme plus an ultrasound-guided corticosteroid injection at the gluteal tendon insertion no later than 7 days after baseline, with optional repeat injection at 6 weeks if NRS >4. Receives: Behavioral: Patient advice; Behavioral: Patient advice plus exercise; Other: Patient advice plus exercise plus corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Rating of Change (GROC)
Proportion of participants reporting "much better" or "very much better" on the GROC, a 7-point scale ranging from "very much worse" to "very much better"
Measured: 3 months
Secondary outcomes (9)
Numeric Rating Scale (NRS) - average hip pain
Self-reported average hip pain intensity over the previous week on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Measured: 1, 2, 3, 6 and 12 months
Numeric Rating Scale (NRS) - night pain
Self-reported worst experienced night pain over the previous week on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Measured: 1, 2, 3, 6 and 12 months
Percentage of time in pain
Self-reported percentage of time pain has been present during the previous week, ranging from 0% (no time in pain) to 100% (in pain at all times). Higher scores indicate more time spent in pain.
Measured: 1, 2, 3, 6 and 12 months
Victorian Institute of Sports Assessment for Gluteal Tendons (VISA-G)
Self-reported hip-related disability measured on a scale ranging from 0 to 100. Higher scores indicate better function and less pain.
Measured: 1, 2, 3, 6, 12 months
Patient Specific Functional Scale (PSFS)
Self-reported functional level for up to five patient-selected activities, each rated on a scale from 0 (unable to perform) to 10 (able to perform at pre-injury level). A mean score is calculated across activities. Higher scores indicate better function.
Measured: 1, 2, 3, 6, 12 months
Pain Self-Efficacy Questionnaire (PSEQ)
Self-reported confidence in performing activities while in pain, measured on a scale ranging from 0 to 60. Higher scores indicate greater pain self-efficacy.
Measured: 1, 2, 3, 6, 12 months
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Health-related quality of life measured as a utility score ranging from -0.624 (worst imaginable health) to 1 (best imaginable health), calculated using Danish population preference weights, and a visual analogue scale ranging from 0 (worst imaginable health) to 100 (best imaginable health). For both calculations, a higher scores indicates better health.
Measured: 1, 2, 3, 6, 12 months
International Physical Activity Questionnaire (IPAQ)
Self-reported physical activity level expressed as MET-minutes per week, calculated as MET level multiplied by minutes and days per week. Higher scores indicate greater physical activity.
Measured: 1, 2, 3, 6, 12 months
Patient Acceptable Symptom State (PASS)
Proportion of participants reporting a symptom level acceptable enough not to require further treatment. Participants are considered to have achieved PASS if they answer "yes" to the question "Is your lateral hip pain at an acceptable level that does not require any further treatment?" Time to first PASS will also be recorded.
Measured: 1, 2, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malene Kjær Bruun
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)
- Responsible party
- Sponsor-investigator, Malene Kjær Bruun, Aalborg University
- Investigators
- Finn E Johannsen, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848971
- Sponsor's protocol ID
- H-26000025
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Prac-tice: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07848971
- Acronym / sponsor ID
- H-26000025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Malene Kjær BruunUniversity, hospital or other
- Collaborators
- Aalborg University, Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain on the outside of the hip, known as greater trochanteric pain syndrome (GTPS), is a common problem. It is caused by irritation of the tendons that attach the buttock muscles to the hip bone. The condition most often affects middle-aged women and makes everyday activities such as walking, climbing stairs, sitting and lying on the painful side difficult. Many people continue to have pain for years. Today, there is no agreed treatment approach for GTPS in general practice, and it is unclear which of the treatments commonly used works best.
This study compares three treatments that are all already used in Danish healthcare. Participants are adults aged 35 or older who have had pain on the outside of the hip for at least 12 weeks and who show typical signs of GTPS on a clinical examination. An ultrasound scan of the hip is performed to rule out a torn tendon. In total, 192 participants will be recruited, mainly through general practice, and also through specialist clinics, a hospital sports medicine department and social media.
Participants are assigned by chance (randomised) to one of three groups:
- Advice: a leaflet explaining the condition and how to manage daily activities, with a brief verbal explanation.
- Advice plus home exercises: the leaflet plus three simple strength exercises done at home three times a week, with written instructions, online videos and an exercise diary.
- Advice plus home exercises plus a steroid injection: the same as group 2, plus a cortisone injection given with ultrasound guidance into the painful area of the hip within a week of the first visit. The injection can be repeated once after 6 weeks if pain persists.
The main question is how many participants in each group feel much better after 3 months. Participants also answer questions about pain, hip function, quality of life, physical activity, exercise adherence, side effects and use of healthcare. Questionnaires are completed online after 1, 2, 3, 6 and 12 months, and participants attend three visits with a clinical examination and ultrasound scan: at the start, after 6 weeks and after 3 months.
The study takes place at two sites in Denmark: Bispebjerg Hospital in Copenhagen and the Research Unit for General Practice in Aalborg. We expect that adding exercises, and adding exercises and an injection, will lead to greater improvement than advice alone. The results will help guide treatment of GTPS in general practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient advice | Active comparator | Behavioral: Patient advicePatient information leaflet on GTPS and load management, handed out at baseline with brief oral information. |
| Patient advice + exercise | Experimental | Behavioral: Patient advice, Behavioral: Patient advice plus exercisePatient information leaflet plus a home exercise programme (hip bridge, hip abduction, squat) performed three times a week, with written instructions, online videos and a training diary. |
| Patient advice + exercise + corticosteroid injection | Experimental | Behavioral: Patient advice, Behavioral: Patient advice plus exercise, Other: Patient advice plus exercise plus corticosteroid injectionPatient information leaflet and home exercise programme plus an ultrasound-guided corticosteroid injection at the gluteal tendon insertion no later than 7 days after baseline, with optional repeat injection at 6 weeks if NRS >4. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 35+ years of age .
- Self-reported lateral hip pain for at least 12 weeks, with an average intensity (when pain is present) of at least 4/10 over the past week on a Numeric Rating Scale (NRS, 0-10; 0 = no hip pain, 10 = worst imaginable hip pain).
- Access to a computer, smartphone, or tablet with an internet connection.
- Tenderness on palpation of the greater trochanter AND at least one of the following:
- Ability to speak and understand Danish (written and oral).
Key exclusion criteria (10 listed)
- Corticosteroid injection in the affected hip within the last 6 months.
- History of systemic inflammatory diseases, e.g., rheumatoid arthritis, spondylarthritis.
- Weekly intake of oral glucocorticoids.
- Individuals with diabetes characterised by unstable or inadequately controlled blood glucose levels (e.g., due to recent medication adjustments or unstable pharmacological management) will be excluded.
- Received any treatment by a healthcare professional for GTPS within the previous 12 weeks or made any substantial changes to usual self-management of the condition in the last 4 weeks (eg, started performing stretching, made a substantial decrease in physical activity level).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient adviceParticipants receive a patient information leaflet describing the GTPS condition and emphasising self-management, particularly load management. The leaflet is based on material from a recent randomised trial (the LEAP trial), translated into Danish and adapted to a Danish context through input from clinicians and patients with GTPS. At baseline, the leaflet is handed out together with a brief verbal summary of the key points. A follow-up phone call is made approximately one week after baseline to address any questions regarding the assigned intervention | Behavioural | Patient advice, Patient advice + exercise, Patient advice + exercise + corticosteroid injection |
| Patient advice plus exerciseParticipants receive a home-based strength exercise programme in addition to the patient information leaflet. The programme consists of three body-weight exercises (hip bridge, hip abduction and squat) to be performed three times per week. At baseline, participants receive a brief standardised verbal introduction of approximately 10 minutes covering key exercises, technique and progression principles. Written instructions with pictures, access to online instruction videos and a training diary are also provided. Participants are instructed to continue exercising until they reach a personally acceptable symptom level, and for an additional four weeks thereafter. Exercise adherence is monitored using the training diary. A follow-up phone call is made approximately one week after baseline to address any questions regarding the exercise programme. | Behavioural | Patient advice + exercise, Patient advice + exercise + corticosteroid injection |
| Patient advice plus exercise plus corticosteroid injectionParticipants receive an ultrasound-guided corticosteroid injection (1 ml triamcinolone 40 mg/ml and 1 ml lidocaine 10 mg/ml) at the insertion of the gluteal tendons on the greater trochanter of the affected hip, administered by a specialist in rheumatology no later than 7 days after the baseline visit. If pain persists at the 6-week follow-up (NRS >4), a repeat injection may be offered. Participants are instructed to begin the exercise programme the day after the injection or as soon as any post-injection pain flare has resolved. | Other | Patient advice + exercise + corticosteroid injection |
Primary outcome
Global Rating of Change (GROC)
Time frame: 3 months
Proportion of participants reporting "much better" or "very much better" on the GROC, a 7-point scale ranging from "very much worse" to "very much better"
9 secondary outcomes
Numeric Rating Scale (NRS) - average hip pain
Time frame: 1, 2, 3, 6 and 12 months
Numeric Rating Scale (NRS) - night pain
Time frame: 1, 2, 3, 6 and 12 months
Percentage of time in pain
Time frame: 1, 2, 3, 6 and 12 months
Victorian Institute of Sports Assessment for Gluteal Tendons (VISA-G)
Time frame: 1, 2, 3, 6, 12 months
Patient Specific Functional Scale (PSFS)
Time frame: 1, 2, 3, 6, 12 months
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 1, 2, 3, 6, 12 months
EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
Time frame: 1, 2, 3, 6, 12 months
International Physical Activity Questionnaire (IPAQ)
Time frame: 1, 2, 3, 6, 12 months
Patient Acceptable Symptom State (PASS)
Time frame: 1, 2, 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Finn E Johannsen principal investigator
Bispebjerg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient advice, Patient advice plus exercise and Patient advice plus exercise plus corticosteroid injection in people with Greater Trochanteric Pain Syndrome and Gluteal Tendinopathy, run by Malene Kjær Bruun at 2 sites 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Finn E Johannsen (31671057, f.e.johannsen@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rating of Change (GROC) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.