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

ConditionsGreater Trochanteric Pain Syndrome Gluteal Tendinopathy Lateral Hip Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35+

SponsorMalene Kjær Bruun

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Reproduction of lateral hip pain with a 30-sec single-leg stance test.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Patient advice
Behavioral
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 exercise
Behavioral
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 injection
Other intervention
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.

Treatment groups

192 Participants

are divided into 3 treatment groups

Group A: Patient adviceActive comparator 1 intervention

Group B: Patient advice + exerciseExperimental treatment 2 interventions

Group C: Patient advice + exercise + corticosteroid injectionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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"

Time frame

3 months

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

1, 2, 3, 6, 12 months

Other outcomes

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).

Time frame

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.

Time frame

Baseline through 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malene Kjær Bruun

Lead sponsor

Aalborg University

Sponsor institution

Aalborg University

Collaborator

Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)

Collaborator

Source ClinicalTrials.gov

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