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

NCT07848971 | Not Yet Recruiting

• 1 other identifier: H-26000025
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 2

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

Conditions

Greater Trochanteric Pain Syndrome; Gluteal Tendinopathy; Lateral Hip Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Numeric Rating Scale (NRS) - average hip pain

  1, 2, 3, 6 and 12 months

• Numeric Rating Scale (NRS) - night pain

  1, 2, 3, 6 and 12 months

• Percentage of time in pain

  1, 2, 3, 6 and 12 months

• Victorian Institute of Sports Assessment for Gluteal Tendons (VISA-G)

  1, 2, 3, 6, 12 months

• Patient Specific Functional Scale (PSFS)

  1, 2, 3, 6, 12 months

Other Outcomes (2)

• Common Terminology Criteria for Adverse Events (CTCAE v5.0)

  Baseline through 12 months

• Health economic outcomes

  Baseline through 12 months

Study Arms (3)

Patient advice

ACTIVE COMPARATOR

Patient information leaflet on GTPS and load management, handed out at baseline with brief oral information.

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.

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.

Behavioral: Patient advice; Behavioral: Patient advice plus exercise; Other: Patient advice plus exercise plus corticosteroid injection

Interventions

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 + exercise; Patient advice + exercise + corticosteroid injection

Patient advice plus exercise plus corticosteroid injection OTHER

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.

Patient advice + exercise + corticosteroid injection

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; Patient advice + exercise; Patient advice + exercise + corticosteroid injection

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Malene Kjær Bruun: lead
• Aalborg University: collaborator
• Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet): collaborator

Study Sites (2)

Forskningsenheden for Almen Praksis i Aalborg

Gistrup, 9260, Denmark

Location

Institut for idrætsmedicin, Bispebjerg og Frederiksberg Hospital

København NV, 2400, Denmark

Location

MeSH Terms

Interventions

Exercise; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Finn E Johannsen

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn E Johannsen

CONTACT

31671057; f.e.johannsen@dadlnet.dk

Malene K Bruun

CONTACT

24415780; mkbruun@dcm.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person responsible for performing statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

DK (2)