Local Injection Under US Control in GTPS.

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesize that local ultrasound guided injection with corticosteroid and local anaesthetic are effective on the symptoms of GTPS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephane Genevay
• Collaborator: University Hospital, Geneva
• Treatments: Anesthetics; Betamethasone; Betamethasone dipropionate, betamethasone sodium phosphate drug combination; Cortisone; Lidocaine

Criteria

Inclusion Criteria:

1. Patients complaining of lateral hip pain for more than 1 month.

2. NRS lateral hip pain score ≥ 4 in the preceding week.

3. Failure of another "standard" treatment:

• Physiotherapy: local therapy or a stretching program, or

• Analgesic treatment (minimum of 5 days of consecutive therapy, including, but not limited to, NSAIDs).

4. Typical lateral hip pain reproduced by palpation of the greater trochanter

Exclusion Criteria:

1. Age younger than 18 years old

2. Concomitant local surgical intervention for tumours, infection or fracture, based on clinical history and physical examination

3. Previous ipsilateral prosthetic hip surgery

4. Scheduled ipsilateral hip surgery within 3 months

5. Fibromyalgia (diagnosis established by a rheumatologist)

6. Flair of chronic inflammatory joint disease (as defined by a rheumatologist)

7. Skin lesions at the injection site

8. Allergy to one of the studied drugs

9. Anticoagulation with internal normalized ration (INR) >3

10. Blood coagulation disorder, such as haemophilia.

11. Serious and uncontrolled psychiatric disease (as assessed by the clinician as a contraindication for steroid)

12. Other contraindications to steroid use, such as:

• uncontrolled diabetes (non-fasting blood glucose > 10 mmol/L)

• unstable hypertension (systolic pressure > 160mmHg or diastolic pressure > 100mmHg), or

• open or closed angle glaucoma.

13. Requirement for systemic steroids (including steroid injections) or dose modification of disease modifying anti-rheumatic drugs during the preceding three months. Oral corticosteroids (< 10mg / day of Prednisone or equivalent) will be permitted providing that the dose has been stable for 4 weeks prior to inclusion and that the patient is expected to remain on the baseline dose for the duration of the study.

14. Presence of a pacemaker or other metallic object that constitutes a CI to MRI, or severe claustrophobia

15. Pregnant women (according to a pregnancy test) or nursing (breastfeeding) mothers.

16. Unwillingness or inability to give informed consent.

17. Unavailability for follow-up