Comparing Standard Care Approaches for Greater Trochanteric Pain Syndrome in General Practice

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.

Participants are assigned by chance (randomised) to one of three groups:

1. Advice: a leaflet explaining the condition and how to manage daily activities, with a brief verbal explanation.
2. 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.
3. 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 Overview

• Status: Not yet recruiting
• Conditions: Gluteal Tendinopathy; Greater Trochanteric Pain Syndrome; Lateral Hip Pain
• Intervention / Treatment: Behavioral: Patient advice; Behavioral: Patient advice plus exercise; Other: Patient advice plus exercise plus corticosteroid injection

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Finn E Johannsen; Phone Number: 31671057; Email: f.e.johannsen@dadlnet.dk
• Study Contact Backup: Name: Malene K Bruun; Phone Number: 24415780; Email: mkbruun@dcm.aau.dk

Study Locations

• Denmark
  • Gistrup, Denmark, 9260
    • Forskningsenheden for Almen Praksis i Aalborg
    • Contact: Malene Kjær Bruun; Phone Number: 24415780; Email: mkbruun@dcm.aau.dk
  • København NV, Denmark, 2400
    • Institut for idrætsmedicin, Bispebjerg og Frederiksberg Hospital
    • Contact: Finn E Johannsen; Phone Number: 31671057; Email: f.e.johannsen@dadlnet.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 35+ years of age .

2. 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).

3. Access to a computer, smartphone, or tablet with an internet connection.

4. Tenderness on palpation of the greater trochanter AND at least one of the following:

   1. Reproduction of lateral hip pain with a 30-sec single-leg stance test.
   2. Reproduction of lateral hip pain with the test Flexion, Adduction and External Rotation with Resistance (FADER-R).

5. Ability to speak and understand Danish (written and oral).

Exclusion Criteria:

1. Corticosteroid injection in the affected hip within the last 6 months.
2. History of systemic inflammatory diseases, e.g., rheumatoid arthritis, spondylarthritis.
3. Weekly intake of oral glucocorticoids.
4. 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.
5. 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).
6. History of prior hip or lumbar back surgery.
7. 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.
8. Physical or mental disabilities that make it impossible to understand and perform exercises and complete questionnaires.
9. Current or planned pregnancy or breastfeeding.
10. Rupture of gluteal tendon identified on ultrasound.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient advice; Patient information leaflet on GTPS and load management, handed out at baseline with brief oral information.	Behavioral: Patient advice; 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
Experimental: Patient advice + exercise; 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.	Behavioral: Patient advice; 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; Behavioral: Patient advice plus exercise; 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.
Experimental: Patient advice + exercise + corticosteroid injection; 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.	Behavioral: Patient advice; 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; Behavioral: Patient advice plus exercise; 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.; Other: Patient advice plus exercise plus corticosteroid injection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	1, 2, 3, 6, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Common Terminology Criteria for Adverse Events (CTCAE v5.0)	Number of participants with adverse events graded by type, severity and causality. Severity is graded on a scale from 1 (mild) to 5 (death).	Baseline through 12 months
Health economic outcomes	Healthcare utilisation, productivity losses and out-of-pocket expenses captured via patient-reported questionnaires, including a modified version of the Oslo Cost Questionnaire (OCC-Q). Quality-adjusted life years (QALYs) calculated from EQ-5D-5L responses using Danish population preference weights, summarised at societal and healthcare system level.	Baseline through 12 months

Collaborators and Investigators

• Sponsor: Malene Kjær Bruun
• Collaborators: Aalborg University; Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)
• Investigators: Principal Investigator: Finn E Johannsen, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 29, 2026
• First Posted (Actual): September 30, 2026

Study Record Updates

• Last Update Posted (Actual): September 30, 2026
• Last Update Submitted That Met QC Criteria: September 29, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Adrenal Cortex Hormones
• Other Study ID Numbers: H-26000025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No